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Dupilumab - Regeneron/Sanofi

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Drug Profile

Dupilumab - Regeneron/Sanofi

Alternative Names: Dupilumab-Sanofi/Regeneron; Dupixent; REGN-668; SAR-231893

Latest Information Update: 03 Apr 2024

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At a glance

  • Originator Regeneron Pharmaceuticals; sanofi-aventis
  • Developer Aimmune Therapeutics; Mayo Clinic; Regeneron Pharmaceuticals; Sanofi; Sanofi-Aventis GmbH
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Antifungals; Antineoplastics; Antipruritics; Immunotherapies; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Interleukin 13 receptor antagonists; Interleukin 4 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Bullous pemphigoid; Eosinophilic oesophagitis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Asthma; Atopic dermatitis; Chronic urticaria; Eosinophilic oesophagitis; Prurigo nodularis; Rhinosinusitis
  • Preregistration Chronic obstructive pulmonary disease
  • Phase III Bullous pemphigoid; Pruritus; Wheezing
  • Phase II/III Eosinophilic gastroenteritis
  • Phase II Aspergillosis; Eczema; Milk hypersensitivity; Prostate cancer; Ulcerative colitis; Urticaria
  • No development reported Allergic asthma
  • Discontinued Grass pollen hypersensitivity; Peanut hypersensitivity

Most Recent Events

  • 03 Apr 2024 Launched for Asthma (Adjunctive treatment, In children) in Norway (SC)
  • 03 Apr 2024 Launched for Atopic dermatitis (Adjunctive treatment, In adolescents) in Norway (SC)
  • 03 Apr 2024 Launched for Atopic dermatitis (Adjunctive treatment, In children) in United Kingdom (SC)

Development Overview

Introduction

Dupilumab, an interleukin-4 receptor alpha (IL-4Rα) antagonist, is a fully human monoclonal antibody, developed by Regeneron Pharmaceuticals and Sanofi (formerly sanofi-aventis), for the treatment of asthma, wheezing, atopic dermatitis, eosinophilic oesophagitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) [rhinosinusitis in development table], chronic obstructive pulmonary disease, pruritus, grass allergy, food allergy, urticaria and chronic spontaneous urticaria [chronic urticaria in development table] and cow's milk allergy [milk hypersensitivity in development table]. It inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. The antibody inhibits IL-4 signaling through the Type I receptor, and both IL-4 and IL-13 signaling through the type II receptor. Inhibition of IL-4 and IL-13 signaling leads to further inhibition of downstream targets such as JAK1/2, JAK1/3, Tyrk2 tyrosine kinases and subsequently STAT6. These pro-inflammatory cytokines are considered as key components in the development of airway inflammation, mucus production, and airway hyper-responsiveness in asthma. Blocking IL-4Rα, inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The product is commercially available for the treatment of atopic dermatitis, in Austria, Australia, Canada, China, Denmark, Germany, Ireland, Japan, Israel, Ireland, Hong Kong, Hungary, Malaysia, Sweden, Finland, Poland, Netherlands, Norway, UK and the US. Dupilumab is launched as an add-on treatment in adults and adolescents with inadequately controlled moderate-to-severe asthma, in USA, UK, Canada, Austria, Australia, Denmark, Finland, France, Germany, Sweden, Ireland, Japan, Netherlands and Norway. It is also available as an adjunctive treatment for chronic rhinosinusitis with nasal polyposis (CRSwNP), in the US and Canada, Japan and Norway and approved in the EU, Lichenstein, Iceland. The candidate is launched for eosinophilic oesophagitis in the US, Canada, Denmark, Sweden, France, Austria, Spain, Netherlands, Hungary, Germany, Czech Republic, Poland, and Ireland. The drug is available in Japan for chronic spontaneous urticaria. The drug is approved in the UK, EU, Lichenstein, Norway and Iceland for the treatment of moderate-to-severe atopic dermatitis in adults. The product is approved in the US and the EU for the treatment of atopic dermatitis as an add-on maintenance treatment for children. It is also approved in Canada as an add-on treatment of severe asthma in children. The product is approved for asthma in children in the US and EU, Lichenstein, Norway and Iceland. The candidate is approved in the EU and Canada for moderate-to-severe atopic dermatitis in infants and children, and under review in eosinophilic oesophagitis in children, adolescents and adults. The candidate is launched in the US, Norway and Japan and approved in EU, Lichenstein, Iceland for the treatment of prurigo nodualris. The is under regulatory review in the US for chronic spontaneous urticaria and in the US, EU and China for chronic obstructive pulmonary disease. Clinical development for prostate cancer, pruritus, allergic asthma, atopic dermatitis, eosinophilic oesophagitis, eosinophilic gastroenteritis, allergic bronchopulmonary aspergillosis, grass pollen hypersensitivity, chronic obstructive pulmonary disease, bullous pemphigoid, prurigo nodualris, chronic urticaria, atopic dermatitis, ulcerative colitis and milk hypersensitivity is underway in several countries worldwide.

As of May 2023, development in chronic cold induced urticaria has been discontinued [1] .

A 300 mg pre-filled pen and 200mg pre-filled pen designed to support more convenient self-administration is approved by the US FDA and 300mg pre-filled pen in Canada.

As of April 2023, dupilumab was discontinued for allergic fungal rhinosinusitis (AFRS) and chronic rhinosinusitis without nasal polyps.

As of July 2022, dupilumab was discontinued for peanut hypersensitivity [2] .Phase II development was underway for grass pollen hypersensitivity. However as March 2021, development of dupilumab for the indication was discontinued. The company was also developing an intravenous formulation of dupilumab in the US, however, the development was discontinued. As at May 2020, no recent reports of development had been identified for phase I development of dupilumab as combination therapy and monotherapy for the treatment of allergic asthma was conducted in the US and the UK.

The antibody emerged as a lead candidate from a research programme aimed at the development of therapeutic antibodies using Regeneron's proprietary VelocImmune® technology, that utilises a proprietary genetically-engineered mouse platform endowed with a genetically-humanised immune system to produce optimised fully-human antibodies.

Sanofi-aventis was renamed as Sanofi in May 2011 [3] .

In October 2020, Aimmune Therapeutics was acquired by Nestle [4] .

Company Agreements

In January 2018, Regeneron and Sanofi entered an agreement to expand and extend a previous agreement signed in November 2007, for the discovery, development and commercialisation of fully-human therapeutic antibodies. The additional investment in the development programme is intended to advance new studies in chronic obstructive pulmonary disease, peanut allergy and grass allergy as well as in patients who have multiple allergic conditions. In November 2009, sanofi-aventis had increased its annual funding from $US100 million to $US160 million from 2010, with an option for an extra three-year extension. The companies aim to advance four to five antibodies into clinical development annually. Under the 2007 agreement, sanofi-aventis increased its ownership in Regeneron from 4% to 19%. It made an upfront payment of $US85 million and was to fund up to $US475 million of research over the following 5 years. sanofi-aventis has the exclusive option to co-develop each drug candidate, where development costs will be shared. Regeneron has the right to co-promote all products worldwide. In the US, profits will be shared equally; outside the US, profits will be split on a sliding scale with sanofi-aventis' share ranging from 65% to 55%. Regeneron will be entitled to receive up to $US250 million in sales milestones when the collaboration achieves certain aggregate annual sales outside the US, starting at $US1 billion [5] [6] [7] .

Key Development Milestones

Atopic dermatitis (AD)

As of January 2024, regulatory submissions are underway in additional countries [8] .

In July 2021, Sanofi reported that the US FDA approved 200mg single-dose pre-filled pen for dupilumab injection (Dupixent®) for the treatment of patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). The 200 mg pre-filled pen is anticipated to be available in the US in August 2021 [9] .

In April 2023, Sanofi announced that Health Canada issued a Notice of Compliance for dupilumab for the treatment of patients with moderate-to-severe atopic dermatitis, aged 6 months to 5 years, whose condition is not well controlled with topical prescription therapies or when those therapies are not recommended [10] .

In March 2023, European Commission approved dupilumab (Dupixent®) in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who were candidates for systemic therapy [11] . Earlier in January 2023, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for dupilumab (Dupixent® ) recommending expanded approval in the European Union (EU). The positive CHMP opinion is supported by data from a Phase III trial in children 6 months to 5 years of age. The European Commission was expected to announce a final decision on the dupixent application in the coming months. As of May 2022, a regulatory application was submitted in the European Union (EU) for dupilumab (Dupixent®) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis [12] [13] .

In June 2022, Regeneron Pharmaceuticals and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved dupilumab (Dupixent®) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable [14] . Earlier, in February 2022, the US FDA had accepted for priority review the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent®) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The target action date for the FDA decision on this investigational use is June 9, 2022. The sBLA application was supported by results from a phase III Liberty AD PRESCHOOL trial (See below) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis [15] ​ (Sanofi pipeline, February 2022).

In June 2021, Sanofi Canada announced that a 300 mg single-dose (single-use) pre-filled pen for dupilumab injection (DUPIXENT®) is available in Canada. The pre-filled pen is approved for all DUPIXENT® indications in patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD), severe asthma and severe chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration [16] .

In February 2021, Sanofi announced that the Health Canada approved dupilumab injection (Dupixent®) for the treatment of moderate-to-severe atopic dermatitis (AD) in children (aged 6 to 11 years), with disease not adequately controlled with topical prescription therapies or when therapies are not
advisable. Later in June 2021, Sanofi announced that Quebec extended public reimbursement of the drug for the Canadians aged 12 years and older and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The decision is taken under the Régie de l'assurance maladie du Québec (RAMQ) [17] [18] .

As of October 2022, Dupixent® (dupilumab) is available in China for the treatment of moderate-to-severe atopic dermatitis [19] . In June 2020, the National Medical Products Administration (NMPA) in China has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The NMPA identified Dupixent as an overseas medicine considered urgently needed in clinical practice, leading to an expedited review and approval process. The approval was based on positive data from the global LIBERTY AD clinical trial [see below] [20] .

In May 2020, the US FDA approved dupilumab (Dupixent®) for children aged six to eleven years with moderate to severe atopic dermatitis. The approval is based on data that included pivotal phase III results on the efficacy and safety of Dupixent combined with topical corticosteroids (TCS) compared to TCS alone [21] .

Dupilumab had been launched in 17 countries including Austria, Ireland and Norway for the treatment of atopic dermatitis in adults and adolescents by the end of 2018 [22] .

Dupilumab was launched in the Netherlands and Denmark for the treatment of moderate to severe atopic dermatitis in adults during the first quarter of 2018 [23] .

As of October 2023, US FDA approved the inclusion of dupilumab data from the 5-year open-label extension study AD-1225 [see below] to the product label for the treatment of adults with moderate-to-severe atopic dermatitis [24] . In May 2017, Regeneron reported that dupilumab (Dupixent®) has been launched in the US, for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescript ion therapies, or when those therapies are not advisable [25] . The product was approved in the US in March 2017. Dupilumab can be used with or without topical corticosteroids. The approval was based on the data from the global LIBERTY AD clinical programme, which included three randomised phase III pivotal trials known as SOLO 1, SOLO 2 and CHRONOS [see below]. In August 2016, Regeneron and Sanofi announced submission of a Biologics License Application (BLA) for inadequately controlled moderate-to-severe atopic dermatitis to the US FDA. The BLA was accepted for priority review in September 2016 and was granted a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2017 [26] [27] [28] [29] .

In January 2024, Regeneron Pharmaceuticals and Sanofi announced that the US FDA has updated the label for dupilumab (Dupixent®) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement [8] . The US FDA, in March 2019, approved dupilumab for the treatment of adolescent patients aged 12-17 years, with moderate-to-severe atopic dermatitis whose disease is inadequately controlled with topical prescription therapies (corticosteroids), or when those therapies are medically inadvisable. Earlier, in October 2018, the FDA accepted and granted priority review for the supplemental Biologics License Application (sBLA) associated with this approval. The sBLA submission was based on data from a pivotal phase III trial [see below] that evaluated the efficacy and safety of dupixent monotherapy in adolescent patients with moderate-to-severe atopic dermatitis [30] [31] .

In February 2021, the European Commission (EC) extended the marketing authorization for dupilumab (Dupixent®) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy [32] . In November 2020, Sanofi announced th at the European Commission (EC) has approved dupilumab for the treatment of atopic dermatitis in children aged six to 11 years. Earlier, in October 2020, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended extension of approval of marketing authorization of dupilumab (Dupixent®) as an add-on maintenance treatment for children aged six to 11 years with severe atopic dermatitis who are candidates for systemic therapy. The recommendation was based on data from a phase III pivotal trial [see below] [21] [33] . In January 2020, Sanofi and Regeneron Pharmaceuticals submitted a Marketing Authorisation Application with the European Medicines Agency (EMA), for dupilumab (Dupixent®) as an add-on maintenance treatment for children aged six to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable [34] .

In August 2019, the European Commission extended marketing authorisation for dupilumab in the European Union (EU) to include adolescents 12 to 17 years of age with moderate to severe atopic dermatitis who are candidates for systemic therapy. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for dupilumab recommending extending its approval in the European Union (EU), in June 2019. The positive opinion was based on clinical data from the LIBERTY AD programme (see below), including a pivotal phase III trial and an open-label extension trial evaluating the efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis [35] [36] .

In September 2017, the EMA granted approv al to dupilumab for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The approval was recommended by Committee for Medicinal Products for Human Use (CHMP) in July 2017, and was based on results from global LIBERTY AD clinical trial programme consisting of SOLO 1, SOLO 2, CHRONOS, SOLO-CONTINUE and CAFÉ phase III trials [see below]. In December 2016, Sanofi and Regeneron reported that the EMA had accepted for review an MAA for dupilumab, which was supported by data from phase III SOLO 1, SOLO 2 and CHRONOS trials [37] [38] [39] .

In October 2018, Sanofi reported the approval of dupilumab for the treatment of adolescent patients (aged 12-17 years) with atopic dermatitis, in the US (Sanofi pipeline, November 2018) [40] .

In February 2018, Sanofi reported that dupilumab (Dupixent®) has been launched in Canada, for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. The product was approved by Health Canada in November 2017. Dupilumab can be used with or without topical corticosteroids. The approval was based on data from the global LIBERTY AD clinical programme, which included three phase III pivotal trials known as SOLO 1, SOLO 2 and CHRONOS. In all the three trials, dupilumab alone or with topical corticosteroids demonstrated rapid and sustained improvement in lesion extent and severity, itch intensity and health-related quality of life measures, specifically. In September 2019, Health Canada expanded the approval for usage of dupilumab subcutaneous injection as a monotherapy for the treatment of adolescent patients, aged 12-17 years, with moderate-to-severe atopic dermatitis whose disease is inadequately controlled with topical prescription therapies, or when those therapies are medically inadvisable. The product was subsequently lauched in Canada for the expanded indication. The approval was based on a phase III trial in which dupilumab showed significantly improve the constant itch and certain quality of life measures in the patients population [41] [42] [43] .

In January 2018, dupilumab was approved in Australia for the treatment of patients with moderate-to-severe atopic dermatitis who are candidates for chronic systemic therapy. The approval was based on data from the global LIBERTY AD clinical programme, which included three phase III pivotal trials known as SOLO 1, SOLO 2 and CHRONOS [44] .

In May 2018, Regeneron announced that the dupilumab was launched in Japan for the treatment of atopic dermatitis. As of February 2023, Ministry of Health, Labor and Welfare in Japan approved dupilumab for the treatment of atopic dermatitis in adolescent patients [45] . Previously, In January 2018, Regeneron announced that the Ministry of Health, Labor and Welfare in Japan granted marketing and manufacturing authorisation for dupilumab (Dupixent®). The product, being commercialised in Japan by Sanofi, can be used with or without topical corticosteroids [46] [47] .

In September 2023, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Dupixent for the treatment of pediatric and adolescent patients with atopic dermatitis [48] . As of February 2023, Regeneron Pharmaceuticals in collaboration with Sanofi filed a sBLA for the approval of dupilumab for the treatment of atopic dermatitis in paediatric patients aged 6 months to 14 years in Japan [45]

In July 2018, Sanofi reported that the Canadian Agency for Drugs and Technologies in Health (CADTH) did not recommend to reimburse dupilumab (Dupixent®), for the treatment of patients with moderate-to-severe atopic dermatitis [49] .

In January 2020, Sanofi and Regeneron Pharmaceuticals announced that the US FDA has accepted its Biologics License Application (sBLA) for priority review for dupilumab as an add-on maintenance treatment for children aged six to 11 year s with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The US FDA has assigned a target action date of May 26, 2020 [50] .

In June 2018, The National Institute for Health and Care Excellence (NICE) provided positive recommendation in Final Appraisal Determination (FAD) for use of dupilumab (Dupixent®) in combination with topical corticosteroids, on the National Health Service (NHS) in England for the treatment of moderate to severe atopic dermatitis in adults with poor response and intolerant to at least one systemic therapy. Healthcare systems in Wales and northern Ireland will implement the NICE guidance. The recommendation is expected to provide access to dupilumab through the NHS and the Early Access to Medicines Scheme (EAMS) in England. NICE is expected to provide final Technology Appraisal Guidance (TAG) for the use of dupilumab on 1 August 2018809243739. Earlier in April 2018, the National Institute for Health and Care Excellence (NICE) issued a draft guidance not recommending dupilumab (Dupixent®) for the treatment of moderate to severe atopic dermatitis in adults when systemic therapy was suitable. Sanofi plans to submit a formal response to the draft NICE guidance [51] .

In March 2017, dupilumab was granted a positive scientific opinion through the Early Access to Medicines Scheme (EAMS), by UK's Medicines and Healthcare Products Regulatory Agency (MHRA). This decision will enable eligible adult patients who have severe AD that has failed to respond to currently approved therapies, and patients with severe AD who are intolerant of, or ineligible for, all approved treatments, in the United Kingdom [52] .

In October 201 6, the US FDA granted Breakthrough therapy designation for dupilumab, for the treatment of moderate to severe (12 to less than 18 years of age) and severe (6 months to less than 12 years of age) atopic dermatitis in paediatric patients, who are not adequately controlled with, or who are intolerant to, topical medication [53] . In November 2014, the Breakthrough therapy designation was granted by the US FDA for dupilumab, for the treatment of patients with moderate-to-severe AD who are not adequately controlled with topical therapy and/or for whom such treatments are inappropriate. The designation was based on results from phase I and II studies [54] .

In December 2015, dupilumab received Promising Innovative Medicine (PIM) status for the treatment of severe atopic dermatitis by the Medicines and Healthcare Products Regulatory Agency (MHRA) [51] .

In June 2021, Regeneron Pharmaceuticals reinitiated an expanded access trial of dupilumab for the treatment of atopic dermatitis, asthma, allergic bronchopulmonary aspergillosis, bullous pemphigoid, eosinophilic oesophagitis, prurigo nodularis and rhinosinusitis (NCT04776694; R668-Dupilumab). The trial was suspended in April 2021 and was earlier initiated in March 2021 [55] .

As of February 2023, Regeneron Pharmaceuticals announced their intention to submit additional sBLA for eosinophilic oesophagitis in paediatric population by mid 2023 [45]

In February 2022, pooled data from the phase III SINUS-24 and SINUS-52 trials in chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma presented at Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology 2022 (ACAAI-2022). In November 2021, pooled data from the phase III SINUS-24 and SINUS-52 trials in chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma presented at Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology 2021 (ACAAI-2021) [56] [57] [58] .

In October 2023, Sanofi and Regeneron Pharmaceuticals completed a phase III trial which was designed to evaluate the efficacy, safety and pharmacokinetics of dupilumab in patients with atopic dermatitis whose disease is not adequately controlled with existing therapies (NCT04678882; EudraCT2020-002601-26; EFC16823). The randomised, double-blind, placebo-controlled trial was initiated in January 2021 and enrolled 62 participants in Japan [59] .

In March 2023, Regeneron Pharmaceuticals reported that the phase III Liberty-AD-HAFT trial that evaluated the efficacy and safety of dupilumab in adult and adolescent patients with moderate-to-severe atopic hand and foot dermatitis, met its primary and secondary end points (NCT04417894; R668-AD-1924; EudraCT2019-003088-22; R668-AD-1924). In November 2022, Regeneron Pharmaceuticals and Sanofi completed the phase III Liberty-AD-HAFT. The open-label trial was initiated in January 2021 and enrolled 133 patients in the US, Poland, Japan and Germany [60] . In March 2023, Regeneron Pharmaceuticals released efficacy and adverse event data from the trial [61] [62] .

In December 2018, Regeneron Pharmaceuticals in collaboration with Sanofi initiated a phase III trial to evaluate the safety and efficacy of dupilumab monotherapy in adult patients with moderate to severe atopic dermatitis (NCT03912259; EFC15116; U1111-1190-7728). The randomised, double blind, placebo controlled trial intends to enrol 160 patients in China [63] .

In February 2023, Regeneron Pharmaceuticals presented biomarker data from the three pivotal phase III LIBERTY AD PEDS, LIBERTY AD PRESCHOOL and LIBERTY AD ADOL trials [see below] at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2023) [64] .

In August 2019, Regeneron Pharmaceuticals and Sanofi reported that the phase III LIBERTY AD PEDS trial evaluating the efficacy of dupilumab in paediatric patients (6-11 year-olds) for the treatment of atopic dermatitis, met its primary and secondary end points (NCT03345914; R668AD1652; EudraCT2016-004997-16; P069-2017; P219-2016) [65] . The primary endpoints were proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75) at 16 weeks. The double-blind, randomised trial, completed in September 2019, enrolled 367 patients in the US, Canada, Czech Republic, Germany, Poland and the UK [66] . In August 2019, the company released positive topline safety and efficacy data of dupilumab from the trial [67] . In April 2020, efficacy and safety data from the trial was released by Regeneron Pharmaceuticals [68] . In February 2021, the company presented efficacy and safety data at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021) [69] [70] [66] . In December, updated efficacy and adverse events data from the trial released by Sanofi [71] .

In March 2017, Regeneron Pharmaceuticals completed the phase III CAFE trial, that investigated the efficacy, safety and tolerability of dupilumab 150 mg/ml SC injection in patients with severe atopic dermatitis, who are inadequately controlled with or are intolerant to oral cyclosporine A, or when this treatment is not medically advisable (R668-AD-1424; NCT02755649; EudraCT2015-002653-35). The primary endpoint was the proportion of patients with EASI 75 (≥ 75% improvement from baseline) at week 16. The double-blind, p arallel, randomised, placebo-controlled trial was initiated in November 2015 and enrolled 325 patients in Poland, Austria, Belgium, Germany, Russia, Spain, Netherlands, Ireland, Russia, Slovakia and the UK [72] . In September 2017, the company released updated efficacy and safety results of the trial [73] [74] .

Regeneron Pharmaceuticals initiated a phase III LIBERTY AD PED-OLE trial in October 2015, to assess the long-term safety and efficacy of dupilumab in children and adolescents with atopic dermatitis (NCT02612454; OLE, R668-AD-1434; EudraCT2015-001396-40). This open-label trial is designed to enrol 880 patients in the US, Canada, Czech Republic, Germany, Hungary, Poland and the UK700261647. In March 2023, Regeneron Pharmaceuticals presented safety data in American Academy of Dermatology annual Meeting 2023 (AAD-2023) [75] . In May 2023, the company presented efficacy and safety data at the American Academy of Dermatology annual Meeting 2023 [76] .

In October 2016, Regeneron Pharmaceuticals completed the phase III LIBERTY AD SOLO-CONTINUE trial, that assessed the efficacy and safety of different dupilumab subcutaneous injection dose regimens, administered as a monotherapy, in patients with atopic dermatitis (Liberty AD Solo-Continue; R668-AD-1415; NCT02395133; EudraCT2014-003384-38). The randomised, double-blind, placebo-controlled, parallel study was initiated in February 2015, and enrolled 475 patients in Lithuania, Estonia, Germany, Finland, Sweden, the UK, Denmark, Spain, Bulgaria, Poland and Italy [77] . In August 2019, the company released efficacy data from the trial [35] . In November 2021, the company presented updated results from this trial at the 2021 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2021) [78] .

Regeneron and Sanofi in October 2016, reported that the phase III LIBERTY AD SOLO 1 and SOLO 2 trials met their secondary endpoints, including itch reduction, improvement in patient anxiety and depression symptoms, and life quality measu res. Earlier, in April 2016, the trials had met their primary endpoints, that assessed the extent and severity of the disease [79] [29] .

In January 2016, Regeneron Pharmaceuticals, in collaboration with Sanofi, completed the phase III LIBERTY AD SOLO 2 trial which investigated the safety and efficacy of dupilumab monotherapy in patients with moderate-to-severe atopic dermatitis (Liberty AD Solo, UKCRN18733, R668-AD-1416; NCT02277769). The randomised, double-blind, placebo-controlled trial was initiated in November 2014, enrolled 708 patients in the US, France, Canada, Germany, Hong Kong, Italy, Lithuania, Poland, South Korea, Sweden and the UK [79] [80] .

In March 2017, Sanofi and Regeneron Pharmaceuticals presented results from the one-year phase III CHRONOS study in patients with moderate-to-severe atopic dermatitis, at the Annual Meeting of the American Academy of Dermatology (AAD-2017)(R668-AD-1224; NCT02260986; EudraCT2013-003254-24; UKCRN17837; CCRN2927) [81] [82] . In October 2016, Regeneron and Sanofi completed the phase III LIBERTY AD CHRONOS trial that evaluated the long-term safety and efficacy of subcutaneous dupilumab, and met its primary endpoints. The randomised, double-blind, placebo-controlled trial compared the combination of dupilumab and topical corticosteroids (TCS) with TCS alone in patients, who had failed or were intolerant to topical steroids with or without topical calcineurin inhibitors. The trial was initiated by Regeneron in July 2014 and enrolled 740 patients in Germany, the Netherlands, Belgium, Hungary, Latvia, Poland, Spain, the UK, Czech Republic, France, Italy, Romania, the US, Canada, Australia, New Zealand, Japan, South Korea and Russia [83] [84] [85] [86] . In February 2024, clinical data was presented at the 2024 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAI-2024) [87] .

Regeneron and Sanofi, in June 2022, completed an open-label phase III extension trial (R668-AD-1225 trial) for patients with moderate-to-severe atopic dermatitis who have previously participated in controlled trials of dupilumab (NCT01949311; EudraCT2013-001449-15). The trial assessed the long-term safety and efficacy, and the primary endpoint of number of treatment-emergent adverse events at weeks 52 and 116. The trial was initiated October 2013, and enroled 2733 patients, by invitation only, in the US, Austria, Belgium, Bulgaria, Canada, China, Denmark, Estonia, Japan, Finland, the Czech Republic, France, Germany, Hungary, Italy, Poland, South Korea, Lithuania, Netherlands, Romania, Russia, Singapore, Slovakia, Spain, the UK, Australia and New Zealand [88] . Data from first-step safety and efficacy analysis were presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2017) [89] . In February 2022, Regeneron presented updated 172 week safety data from the trial at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [90] . Updated adverse event data from the trial was presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [91] . In November 2023, efficacy data was presented at the 2023 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI - 2023). In February 2024, results from this trial were presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024) [92] [93]

In February 2016, Regeneron Pharmaceuticals, in collaboration with Sanofi completed the phase III SOLO 1 trial that evaluated the safety and efficacy of dupilumab monotherapy for the treatment of patients with moderate-to-severe atopic dermatitis (R668-AD-1334; NCT02277743; EudraCT2014-001198-15; IND107969). The primary endpoint was the proportion of patients who achieved an Investigator Global Assessment of 0 to 1 and a reduction of ≥ 2 points from baseline , at week 16. Patients, who were not controlled with topical medications, or for whom, topical treatment was medically forbidden, were enrolled. Evaluation was conducted using the Investigator's Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe), and entry criteria required a baseline score of 3 or 4. Patients were also measured on Eczema Area and Severity Index (EASI). The trial included randomisation of patients across three treatment groups, dupilumab 300mg subcutaneously once per week, dupilumab 300mg subcutaneously every two weeks, or treatment with placebo for 16 weeks following an initial dupilumab loading dose of 600mg subcutaneously, or placebo. The randomized, double-blind, placebo-controlled trial was initiated in October 2014, that enrolled 674 patients in the US, Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Japan, Singapore and Spain [79] [94] .

In the first quarter of 2016, Regeneron Pharmaceuticals initiated the phase III LIBERTY AD CAFÉ trial of dupilumab in severe atopic dermatitis. The trial investigated two dose regimens of dupilumab (300 mg weekly and 300 mg every two weeks) with concomitant topical corticosteroids in adult patients with severe atopic dermatitis who are not adequately controlled with, or are intolerant to or ineligible for, oral cyclosporine A therapy. The primary endpoint of this trial is the proportion of patients with a 75% or greater improvement from baseline in their EASI score. In April 2017, Sanofi reported positive results form the trial and demonstrated an acceptable safety profile. These results will be submitted to the EMA [95] .

The global phase III LIBERTY AD clinical programme will consist of at least five trials of dupilumab in patients with moderate-to-severe atopic dermatitis [84] [85] .

In September 2018, Sanofi released positive phase III trial results of dupilumab monotherapy in adolescent patients with moderate-to-severe atopic dermatitis.

In June 2018, Regeneron Pharmaceuticals and Sanofi completed the phase III LIBERTY AD ADOL trial which met its primary and key secondary endpoints of the proportion of participants with Investigator Global Assessment (IGA) 0 to 1 and proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline), respectively. The trial evaluated the efficacy and safety of dupilumab subcutaneous injection as a monotherapy in adolescent patients with moderate-to-severe atopic dermatitis, whose disease could not be adequately controlled with topical medications or for whom topical treatment was medically inadvisable (R668-AD-1526; EudraCT2015-004458-16; NCT03054428). The randomised, double blind, placebo controlled, parallel-group trial was initiated in April 2017, and enrolled 251 patients in Canada and the US [96] . In March 2019, safety and efficacy data from this trial were presented at the 77th Annual Meeting of the American Academy of Dermatology (AAD-2019) [97] [98] [99] [100] [101] . In November 2021, the company presented updated results from this trial at the 2021 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2021) [102] .

In July 2021, Regeneron completed the phase II/III LIBERTY AD PRESCHOOL trial that evaluated the pharmacokinetics, safety and efficacy of dupilumab in patients aged ≥ 6 months to < 6 years with severe atopic dermatitis (R668-AD-1539; NCT03346434; EudraCT2016-000955-28; P219-2016; P374-2019). The non-randomised, open-label extension& #160;trial was initiated in November 2017 and enrolled 162 patients in the US, Germany, Poland and UK. In August 2021, the company reported that the pivotal phase III trial of dupilumab for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitisb met its primary and all secondary endpoints and released positive safety and efficacy data from this trial [103] [104] [105] . In December 2021, Regeneron announced that the data from the trial will form the basis of global regulatory submissions for this age group in the US and in the EU [105] . In September 2022, company released the efficacy and safety data from the trial [106] . In February 2023, the company presented efficacy results from the trial at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2023) [107] . In March 2023, company released the efficacy data from the trial [108] . In March 2023, Regeneron Pharmaceuticals presented efficacy and safety data in American Academy of Dermatology annual Meeting 2023 (AAD-2023) [62] . In November 2023, the company presented efficacy data from the trial at the Annual Scientific Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2023) [109] .

In March 2020, Regeneron Pharmaceuticals completed a phase II trial to assess the efficacy and safety of REGN 3500 monotherapy and combination of REGN 3500 plus dupilumab in adult patients with moderate-to-severe atopic dermatitis (NCT03736967; R3500AD1798; EudraCT2018-001543-30). The double-blind, randomised trial initiated in November 2018 enrolled 280 patients in the US, Netherlands, Germany and Spain. The trial was prematurely ended in Germany and Spain [110] .

Regeneron, in March 2016, completed a phase IIa trial that assessed the safety, pharmacokinetics, immunogenicity and efficacy of dupilumab in paediatric patients with AD (R668-AD-1412; EudraCT2014-003263-37; NCT02407756). The study enrolled 78 patients in Canada, Hungary, Poland, Czech Republic, Germany and the UK [111] [112] .

In August 2014, Regeneron and Sanofi initiated a 32-week, double-blinded phase II trial to evaluate the immune response to subcutaneous dupilumab in patients with moderate to severe atopic dermatitis (R668-AD-1314; NCT02210780). The trial was completed in the US in September 2015. The trial enrolled 194 patients who were randomised to receive either dupilumab or placebo [113] .

Regeneron and Sanofi completed a randomised, double-blind, placebo-controlled phase II trial designed to assess the safety, efficacy, serum concentration and biomarker profile of dupilumab in adult patients with moderate-to-severe atopic dermatitis in January 2015 (R668-AD-1307; NCT01979016). The primary endpoint is the change in Eczema Area and Severity Index score to week 16. The trial was initiated in December 2013 and enrolled 54 patients in the US and Canada [114] .

Regeneron and Sanofi completed a randomised, double-blind, placebo-controlled phase IIb trial in September 2014, which assessed the efficacy, safety, pharmacokinetic and biomarker profiles of multiple dose regimens of subcutaneous dupilumab in patients with moderate-to-severe atopic dermatitis (R668-AD-1021; NCT01859988; EudraCT2012-003651-11). The primary endpoint was the percent change in Eczema Area and Severity Index score from baseline to week 16. The trial was initiated in May 2013 and enrolment of 380 patients was completed in the US, Canada, Japan, Czech Republic, Hungary, Germany and Poland. Results from the study were reported in July 2014 [115] [116] .

In July 2012, Regeneron and Sanofi initiated a randomised, double-blind, placebo-controlled phase II trial to assess the safety of subcutaneous dupilumab, administered concomitantly with topical cortic osteroids, in patients with moderate-to-severe atopic dermatitis (NCT01639040; Eudra2012-000946-37). Dupilumab was administered four times, and adverse events were monitored for 78 days. The trial enrolled 31 adult patients in Germany, Hungary and Poland, and was completed in December 2012 [117] .

Regeneron, in collaboration with Sanofi, conducted a randomised, double-blind, placebo-controlled phase II trial of repeated subcutaneous doses of dupilumab in patients with extrinsic moderate-to-severe atopic dermatitis (NCT01548404; EudraCT2011-003836-29). The primary outcome measure was the change in Eczema Area and Severity Index score to week 12. The trial enrolled 109 patients in the Czech Republic, France, Germany, Hungary and Poland, and was completed in July 2013. Regeneron released clinical data from the trial demonstrating that statistically significant clinical outcomes including rapid and marked sustained improvements in Eczema Severe Score Index (EASI), Scoring of Atopic Dermatitis (SCORAD), Investigator's Global Assessment Score (IGA), baseline Body Surface Area (BSA) and pruritus were observed in the duplimab arm, when compared with placebo arm (Regeneron, Form 10-K, February 2015) [118] .

A randomised, double-blind, placebo-controlled phase I/II trial of subcutaneous dupilumab in adult patients with moderate-to-severe atopic dermatitis was completed by Regeneron and Sanofi in March 2012 (R668-AD-1026; NCT01385657). The 12-week trial assessed treatment-emergent adverse events in 37 patients in Germany, Australia and New Zealand [119] .

In February 2018, Regeneron and Sanofi completed a phase I actual use study that assessed the technical performance and user injections of dupilumab auto-injection device, by patients with moderate-to-severe atopic dermatitis (R668-AD-1607; NCT03050151). Evaluation of the number of vali dated AI device-associated product technical failures (PTFs) and type of validated AI device-associated PTFs were the primary endpoints of the trial. The randomised, open label trial was initiated in March 2017, and enrolled 176 patients in the US [120] .

Regeneron Pharmaceuticals, in July 2016, completed a phase I trial designed to investigate the drug-drug interaction effects of dupilumab on the pharmacokinetics of selected cytochrome p450 substrates in patients with moderate to severe atopic dermatitis (NCT02647086; R668-AD-1433). The non-randomised trial was initiated in December 2015, and enrolled 14 participants in the US [121] .

Positive proof-of-concept data from two phase Ib trial were reported by Sanofi and Regeneron in March 2013. Significant improvements in scores for body surface area, investigator global assessment, and eczema area severity index were achieved in dupilumab compared with placebo recipients at week 4 and these improvements were maintained at week 8 in the highest dose examined. These were pooled data from two trials that were conducted, collectively, in the US, Germany, Australia and New Zealand and involved a total of 67 patients [122] [123] .

Later, in October 2012, Regeneron and Sanofi completed a second randomised, double-blind, placebo-controlled, 12-week phase Ib trial to assess the safety and pharmacokinetics of subcutaneous dupilumab in adult patients with moderate-to-severe extrinsic atopic dermatitis (NCT01259323). The 12-week, sequential ascending, repeated-dose trial enrolled 30 patients in the US [124] .

Asthma

In October 2021, the US FDA approved dupilumab (Dupixent®) as an add-on maintenance treatment of patients aged, 6 to 11 years with moderate-to-severe asthma characterised by an eosinophilic phenot ype or with oral corticosteroid-dependent asthma [125] . Earlier, in March 2021, Sanofi announced that the US FDA accepted for review the supplemental Biologics License Application (sBLA) for dupilumab as an add-on treatment for children aged, 6 to 11 years with uncontrolled moderate-to-severe asthma characterised by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. The target action date for the US FDA decision is October 21, 2021. The sBLA is supported by data from the pivotal phase III LIBERTY ASTHMA VOYAGE trial [see below] [126] .

In October 2021, the National Institute for Health and Care Excellence (NICE) had issued a final appraisal determination (FAD) recommending dupilumab (Dupixent®), as an add-on maintenance treatment for severe asthma. The NICE FAD was based on a subset of patients taking part in the LIBERTY ASTHMA QUEST clinical trial [see below], with high exacerbation rates and high biomarkers indicating type 2 inflammation. The publication date of NICE Final Guidance for the use of dupilumab within NHS England for treating severe asthma, will make drug available through NHS England within three months from the date of publication [127] .

In April 2022, the European Commission expanded the marketing authorisation for dupilumab in the European Union by approving the drug in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment [128] . Earlier, in January 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opin ion, recommending to extend the approval of dupilumab in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma. The European Commission is expected to announce a final decision on the Dupixent application in the coming months [129] . In May 2021, Regeneron Pharmaceuticals submitted regulatory application to the EMA for dupilumab as an add-on treatment for children, aged 6 to 11 years, with severe asthma [130] .

In May 2019, the European Commission approved dupilumab (DUPIXENT®) for its use as an add-on maintenance treatment in adults and adolescents (aged ≥ 12 years) with inadequately controlled (by inhaled high dose corticosteroids combined with another asthma medicinal product) moderate-to-severe asthma, with type II inflammation characterised by increased blood eosinophils and/or raised exhaled nitric oxide. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of dupilumab (DUPIXENT®) in March 2019. This positive opinion was based on clinical data from 2 888 adults and adolescents (aged ≥ 12 years) who participated in three pivotal trials from the global LIBERTY ASTHMA program, including the phase III QUEST and VENTURE trials. Earlier, in April 2018, the EMA accepted an application to review dupilumab [131] [132] [133] [134] .

In March 2022, Sanofi-Aventis Canada announced the expanded approval of Dupixent® (dupilumab injection) as an add-on maintenance treatment in patients aged six to 11 years with severe asthma with a type 2 / eosinophilic phenotype or oral corticosteroid-dependent asthma, in Canada. The approval is based on the VOYAGE phase III trial (see below) [135] . In June 2021, Sanofi Canada announced that a 300 mg single-dose (single-use) pre-filled pen for dupilumab injection (DUPIXENT®) is available in Canada. The pre-filled pen is approved for all DUPIXENT® indications in patients aged 12 years and older with severe asthma, for at-home administration [16] . Earlier, in November 2020, Health Canada approved supplemental New Drug Submission application (sNDS) for dupilumab as an add-on maintenance treatment for patients aged 12 years and older with severe asthma characterized with high type 2 eosinophilic phenotype or the disease inadequately controlled by oral corticosteroids. The drug was subsequently launched in Canada [136] .

In March 2019, PMDA approved dupilumab as an add-on treatment for adults and adolescents (aged ≥ 12 years) with inadequately controlled (by inhaled high dose corticosteroids combined with another asthma medicinal product) moderate-to-severe asthma. The drug was subsequently launched in April 2019 [137] .

In October 2018, Sanofi announced that the US FDA approved dupilumab as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older, with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. sBLA was accepted for review by the US FDA, in March 2018 The PDUFA action date is October 20, 2018. The sBLA is supported by data from 2 888 adults and adolescents who participated in three pivotal trials from the LIBERTY ASTHMA clinical development programme. Detailed data from the phase III QUEST and VENTURE trials will be submitted for presentation at medical meetings later in 2018 [138] [139] . In Q4 2017, Regeneron submitted the sBLA to the FDA [47] [101] .

In March 2021, Sanofi announced that it has planned the EU regulatory submission for children aged 6 to 11 years for treatment of asthma is planned Q1 2021 [126] .

As at April 2018, Sanofi filed an supplmental Biologics License Application (sBLA) of dupilumab as a treatment for moderate-to-severe asthma in adults and adolescents [140] .

In January 2024, Regeneron Pharmaceuticals in collaboration with Sanofi initiated a phase III LIBERTY ASTHMA TREKIDS trial to evaluate the efficacy and long-term safety of dupilumab in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze (NCT06191315; EFC14771; CTIS-2023-504331-41; ICTRP-U1111-1246-7432). The randomised, double-blind, placebo-controlled, parallel group trial is designed to enrol approximately 90 patients in the US, Argentina and Canada [141] .

In October 2022, Sanofi and McMaster University completed a phase III trial that evaluated the effect of dupilumab on airway hyper-responsiveness and ventilation heterogeneity in patients with asthma (NCT03884842; 11963). The placebo-controlled, randomized was initiated in July 2019 and enrolled 24 participants in the Canada [142] .

In May 2022, Sanofi and Regeneron Pharmaceuticals completed a phase III trial that evaluated the efficacy, safety and tolerability of dupilumab, in patients with persistent asthma (CTRI2019-01-016928; EFC13995; U1111-1175-0772; NCT03782532). Evaluation of the change in pre-bronchodilator forced expiratory volume was the defined primary endpoint of the trial. The randomised, double-blind trial was initiated in January 2019 and enroled approximately 486 patients in China and India [143] . In May 2023, results from the trial were presented at the 119th International Conference of the American Thoracic Society [144] . In September 2023, the company presented updated data from the trial at the 33rd Annual Congress of the European Respiratory Society (ERS-2023) [145]

In June 2018, Regeneron Pharmaceuticals and Sanofi initiated the phase III Liberty Asthma Excursion trial to evaluate the long-term safety and tolerability of dupilumab SC in chil dren, aged 7 to 12 years with asthma who completed the treatment in a dupilumab asthma trial; EFC14153 (see below) (NCT03560466; P021-2017; EudraCT2017-003317-25; LTS14424; U1111-1200-1757). The open-label, single group assignment trial will enrol approximately 365 patients in the US, Argentina, Australia, Brazil, Canada, Chile, Colombia, Hungary, Italy, Japan, Lithuania, Mexico, Poland, Romania, Russia, South Africa, Spain, Turkey and Ukraine [146] . In September 2022, safety data from the trial were released by the company [147] . In September 2022, efficacy data from the trial were released by company [148] . In December 2022, company presented phase III (Liberty Asthma Excursion) trial data at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2022) [149] . In February 2023, Regeneron Pharmaceuticals presented efficacy and safety data at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2023) [150] . In May 2023, updated efficacy results from this trial was presented at 119th International Conference of the American Thoracic Society (ATS-2023) [151] . In September 2023, the Company presented trial data at the 33rd Annual Congress of the European Respiratory Society (ERS-2023) [152]

In October 2020, the pivotal phase III LIBERTY ASTHMA VOYAGE trial met its primary and all key secondary endpoints. In August 2020, Regeneron Pharmaceuticals and Sanofi completed the trial that assessed the efficacy, safety and tolerability of dupilumab SC in children, aged six to 11 years, with uncontrolled persistent asthma (EFC14153; EudraCT2016-001607-23; U1111-1179-4851; NCT02948959). The randomised, double-blind, parallel, placebo-controlled trial was initiated in March 2017 and enrolled 408 patients in the US, Argentina, Australia, Brazil, Canada, Chile, Colombia, Hungary, Italy, Lithuania, Mexico, Poland, Romania, Russia, South Africa, Spain, Turkey and Ukraine. In October 2020, data was released by the company. In May 2021, the company released updated efficacy data from the trial. In May 2021, updated results from the trial were presented at 117th International Conference of the American Thoracic Society (ATS-2021). In December 2021, updated da ta were released by the company and published in the New England Journal of Medicine [153] [154] [155] [156] [101] [157] . In November 2021, biomarker data from the trial was presented at Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2021) [158] . In September 2021, updated efficacy results were presented at the 31st Annual Congress of the European Respiratory Society (ERS-2021) [159] [160] . In February 2022, pharmacodynamics data was presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [161] . In May 2022, the company presented an updated efficacy data from the trial at the 118th International Conference of the American Thoracic Society (ATS-2022) [162] [163] . In September 2022, the company presented updated efficacy results from the trial at the 32nd Annual Congress of the European Respiratory Society (ERS-2022) [164] [165] . In February 2023, the company presented updated efficacy results from the trial at Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2023) [166] . In May 2023, company presented efficacy data from the trial at 119th International Conference of the American Thoracic Society (ATS-2023) [167] .

In September 2022, efficacy data from a phase III LIBERTY ASTHMA QUEST [see below] and LIBERTY ASTHMA TRAVERSE [see below] trial in asthma presented at the 32nd Annual Congress of the European Respiratory Society (ERS-2022) [168] .

In May 2023, Regeneron Pharmaceuticals presented updated pooled efficacy data from the phase III LIBERTY ASTHMA QUEST and LIBERTY ASTHMA TRAVERSE trials [see below] at the 119th International Conference of the American Thoracic Society (ATS-2023) [169] . Earlier in February 2022, efficacy data from the trials were presented at the 2022 Annual Meeting of the American Academy of Allergy, Asthma and Immunology(AAAAI-2022) [170] [171] [172] .

In September 2017, Sanofi and Regeneron announced that, the phase III LIBERTY ASTHMA QUEST trial met its two primary endpoints of reduction in the rate of severe exacerbation events at 52 weeks and improvement in the lung function at 12 weeks (EFC13579; NCT02414854; EudraCT2014-004940-36). The trial was completed in November 2017. The trial was initiated in April 2015, to investigate the safety and efficacy of dupilumab in patients with persistent asthma, on a medium or high dose inhaled corticosteroid and up to two additional controller medicine therapy. The randomised, double-blind, placebo-controlled trial enrolled 1 902 adolescent as well as adult patients in the US, Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, South Korea, Mexico, Poland, Russia, South Africa, Spain, Taiwan, Turkey, Ukraine and the UK [173] [53] [171] . In May 2018, detailed results from the trial were published in the New England Journal of Medicine [174] . The results from the QUEST trial were presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology in February 2019 (AAAAI, 2019), held at France [175] . In May 2019, efficacy results from the trial were presented at the 115th International Conference of the American Thoracic Society (ATS-2019). Updated efficacy data from the trial were presented at the 29th Annual Congress of the European Respiratory Society (ERS-2019). In September 2020, Regeneron Pharmaceuticals presented results from the trial at the 30th Annual Congress of the European Respir atory Society (ERS-2020). In February 2021, updated efficacy data from the trial were presented at the 2021 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021) [176] [177] [178] [179] [180] [181] [182] . In November 2021, data from the trial was presented at Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2021) [183] . In May 2022, the company presented pharmacodynamics data from the trial at the 118th International Conference of the American Thoracic Society (ATS-2022). In September 2022, the updated efficacy data was presented at 32nd annual congress of the european respiratory society (ERS-2022) [184] [185] .

Regeneron and Sanofi completed the phase III LIBERTY ASTHMA TRAVERSE extension study, in October 2019, that was designed to investigate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous phase IIb dupilumab asthma study (LTS12551; NCT02134028, EudraCT2013-003856-19; U1111-1117-6745). The primary endpoint was adverse events, assessed at week 112. The open label study was initiated in July 2014, and enrolled 2282 patients in the US, Argentina, Belgium, Brazil, Colombia, Denmark, Hungary, Romania, Taiwan, Sweden, Australia, Canada, Chile, France, Germany, Israel, Italy, Japan, South Korea, Mexico, Russia, Netherlands, Poland, South Africa, Spain, Turkey, Ukraine and the UK. In September 2020, company released efficacy and safety data from the trial. In February 2021, updated efficacy data from the trial were presented at the 2021 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021). In May 2021, trial results were presented at the 117th International Conference of the American Thoracic Society (ATS-2021). In September 2021, company presented data from the trial at the 31st Annual Congress of the European Respiratory Society (ERS-2021). Patients from TRAVERSE continued to significantly reduce the use of oral corticosteroids (OCS) from baseline of VENTURE. Additionally, patients' exacerbations rates remained low, and their FEV1 improved [186] [187] [188] [189] [172] [190] [191] . In May 2022, updated efficacy data from the phase III LIBERTY ASTHMA TRAVERSE trial were presented at the 118th International Conference of the American Thoracic Society (ATS-2022) [192] . In September 2022, Regeneron Pharmaceuticals presented efficacy and adverse event data from the trial at 32nd Annual Congress of the European Respiratory Society 2022 (ERS-2022) [193] . In November 2022, company released additional efficacy data at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACCAI-2022) [194] . In February 2023, results from this trial were presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI -2023) [195] . In May 2023, results were presented at 119th International Conference of the American Thoracic Society (ATS-2023) [196] [197] .

In February 2022, Sanofi in collaboration with Regeneron Pharmaceuticals completed a long-term safety study of dupulimab in patients with moderate to severe asthma who completed TRAVERSE-LTS12551 trial (LPS15023; EudraCT2017-002134-23; U1111-1196-5369; NCT03620747). The open-label trial was initiated in August 2018, and enroled 397 patients in the US, Belgium, Germany, the Netherlands, and France [198] .

A randomised, double-blind, pl acebo-controlled, parallel group phase III trial has been initiated to evaluate the efficacy and safety of dupilumab in adolescents and adults with moderate to severe uncontrolled asthma (RESP 3821 (Asthma); UKCRN 18537). The trial is recruiting 720 patients in the UK [199] .

In October 2017, Regeneron Pharmaceuticals reported that primary and key secondary endpoints were met in the phase III LIBERTY ASTHMA VENTURE trial which was completed in November 2017 (EFC13691; U1111-1170-7152, NCT02528214, EudraCT2015-001573-40). The trial evaluated efficacy of dupilumab for reducing the use of maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma. The placebo-controlled, randomised trial initiated in October 2015 enrolled 210 patients in the US, Argentina, Belgium, Brazil, Canada, Chile, Colombia, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russia, Spain and Ukraine. Updated efficacy results from the trial were released in October 2017 [200] [201] [202] . In May 2018, detailed results from the trial were published in the New England Journal of Medicine and were also presented at the 114th International Conference of the American Thoracic Society (ATS-2018) [203] [174] . In May 2019, efficacy and safety data from the phase III ASTHMA VENTURE trial were presented at the 115th International Conference of the American Thoracic Society (ATS-2019). In September 2020, efficacy data from the trial were presented at the 30th Annual Congress of the European Respiratory Society (ERS-2020). In September 2021, company presented the data from the trial at the 31st Annual Congress of the European Respiratory Society (ERS-2021). Duplilumab decreased oral corticosteroids (OCS) dose by 73% and 69% versus baseline. Fu rthermore, it reduced exacerbation rates by 72% and 45% vs placebo in patients with and without an allergic phenotype, respectively. Pre-BD FEV1 was also improved in both the groups [204] [205] [206] [207] . In November 2023, results from the trial were presented at the 2023 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2023) [208] [209] .

In August 2019, Sanofi completed the phase II proof-of-concept trial that met the primary endpoint of improvement in loss of asthma control and secondary endpoint of significant improvement in lung function by SAR 440340 monotherapy compared with placebo (NCT03387852; EudraCT2017-003289-29). The trial evaluated the efficacy, safety, and tolerability of SAR 440340 [see ADIS Insight Drug profile 800048225] and the co-administration of SAR 440340 with dupilumab in patients with asthma. The randomised, double blind, placebo controlled trial was initiated in March 2018, and enrolled 301 patients in the US, Ukraine, Turkey, Russia, Poland, Mexico, Chile and Argentina. In June 2019, efficacy and adverse events data from the trial were released by Regeneron [210] [211] .

Regeneron and Sanofi completed a randomised, double-blind, placebo-controlled phase IIb trial in April 2015. The trial evaluated different dosages and regimens of subcutaneous dupilumab in patients with moderate to severe, uncontrolled asthma on inhaled corticosteroid/long-acting β-2 agonist combination therapy (NCT01854047; EudraCT2013-000856-16). Regeneron and Sanofi plan to meet with the FDA and other regulators to determine next steps for developmenent of dupilumab in this indication. The primary endpoint was the change in FEV1 at 12 weeks. The trial was initiated in June 2013 and completed enrolment of 776 patients in the US, Australia, Argentina, Chile, Japan, France, Mexico, South Korea, New Zealand, Poland, Sout h Africa, Russia, Turkey, Ukraine, Italy and Spain, in August 2014 [212] [213] [214] . The trial met its primary endpoint. Based on discussions with the US FDA, data from the phase IIb trial and the LIBERTY ASTHMA QUEST trial may be considered for the potential submission of a BLA for asthma [215] [216] [217] .

In January 2018, Sanofi, in collaboration with Regeneron, completed a phase II EXPEDITION trial, which evaluated the effect of SC dupilumab on airway inflammation, in patients with persistent asthma (PDY14192; EudraCT2015-001572-22; U1111-1170-7168; NCT02573233). The primary endpoint was the change in number of inflammatory cells and mucin-stained area in the bronchial submucosa per square millimeter at 12 weeks. The randomised, double-blind, placebo-controlled trial was initiated in January 2016 and enrolled 42 patients in Canada, Denmark, Germany, Sweden, the United Kingdom and the US [218] .

Allergic bronchopulmonary aspergillosis (Aspergillosis in development table)

In February 2024, Regeneron Pharmaceuticals in collaboration with Sanofi completed a phase II LIBERTY ABPA AIRED trial designed to evaluate the efficacy and safety of dupilumab in patients with allergic bronchopulmonary aspergillosis (NCT04442269; EudraCT2019-002619-24; R668-ABPA-1923). The randomised, double-blind, placebo-controlled trial was initiated in September 2020 and enrolled 62 patients in the US, Bulgaria, France, Germany, Hungary, Japan, Netherlands, Poland, Romania and the UK [219] .

Chronic obstructive pulmonary disease (COPD)

In February 2024, the US FDA accepted for priority review the supplemental Biologics License Application (sBLA) for dupilumab as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024. The sBLA submission was supported by data from the phase III COPD clinical research program including BOREAS, NOTUS trials [See below] [220] [221]

As of Februrary 2024, Regeneron submitted BLA to US FDA and China for dupilumab in chronic obstructive pulmonary disease [222] .

As of August 2023, US FDA granted Breakthrough Therapy designation to dupilumab for uncontrolled COPD with an eosiniphilic phenotype based on the positive results of the phase III BOREAS study [223] .

In November 2023, Regeneron announced that the European Medicines Agency is reviewing Regeneron and Sanofi’s application for dupixent for the treatment of uncontrolled COPD with type 2 inflammation. The application is based on results from the BOREAS trial [see below] [224]

In November 2023, Regeneron announced that the phase III NOTUS trial met the primary endpoint that showed dupixent significantly reduced exacerbations by 34% compared to placebo in patients with moderate-to-severe COPD with evidence of type 2 inflammation. Earlier, in June 2020, Sanofi initiated a phase III NOTUS trial to evaluate the efficacy, safety and tolerability of dupilumab in patients with moderat e to severe COPD with Type 2 inflammation (EudraCT2018-001954-91; EFC15805; NCT04456673; U1111-1211-8837). The randomized, double-blind, placebo-controlled and parallel-group trial intends to enrol 935 patients in US, Argentina, Australia, Brazil, Canada, Chile, Colombia, Mexico, Peru, Serbia, Russia, South Africa, Ukraine, Germany, Latvia, the Netherlands, Lithuania, Bulgaria, the UK, France, Portugal, Poland, Spain, Greece, Belgium, Hungary, Czech Republic, Slovakia and Romania [224] [225] .

In March 2023, Regeneron and Sanofi announced that dupilumab met the primary and all key secondary endpoints in a phase III BOREAS trial which was completed in May 2023. The trial evaluated the efficacy, safety and tolerability of dupilumab, in patients with moderate-to severe COPD, with type 2 inflammation (EFC15804; U1111-1211-8804; EudraCT2018-001953-28; NCT03930732; JapicCTI194839). Evaluation of the annualised rate of acute moderate and severe COPD exacerbation is the defined primary endpoint of the trial. The randomised, double blind trial was initiated in April 2019 and has enrolled 939 patients in the US, Argentina, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, Germany, Hungary, Israel, Italy, Japan, South Korea, Mexico, Poland, Romania, Russia, Slovakia, Spain, Sweden, Turkey and Ukraine [226] . In June 2020, the trial met a blinded, stringent early efficacy threshold [227] .The company released efficacy and safety data from the study. In May 2023, updated efficacy data from the trial were released by Regeneron [228] [229] . In same month, data from the trial were presented at the 119th International Conference of the American Thoracic Society (ATS-2023) [230] .

Chronic urticaria

In February 2024 Company launched Dupixent® (dupilumab) in Japan [231] . In February 2024, Ministry of Health, Labor and Welfare (MHLW) granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. The approval is based on results of Study A of the LIBERTY-CUPID clinical trial (see below) [232] . Earlier prior to April 2023, Regeneron Pharmaceuticals and Sanofi announced that an application submitted to the Pharmaceuticals and Medical Devices Agency (PDMA) and accepted for review in Japan for chronic spontaneous urticaria [233] .

In February 2024, Sanofi and Regenerone Pharmaceuticals announced its intention to submit a regulatory application for Chronic urticaria in 2025 (Sanofi pipeline, February 2024).

In October 2023, Regeneron and Sanofi announced that the US FDA has issued a Complete Response Letter (CRL) for the sBLA of Dupilumab for the treatment of chronic spontaneous urticaria (CSU) [234] . In March 2023, Regeneron Pharmaceuticals and Sanofi announced that the US FDA accepted for review the supplemental Biologics License Application (sBLA) for dupilumab to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care, H1 antihistamine treatment. The target action date for the FDA decision is October 22, 2023. The sBLA was supported by data from two phase III trials (LIBERTY-CUPID Studies A and B) [see below] [235] .

As of February 2023, Regeneron Pharmaceuticals initiated a phase III trial to evaluate the efficacy of dupilumab in biologic-naïve patients with chronic spontaneous urticaria. The phase III trial intends to enroll patients in an undisclosed location [45]

In August 2022, Sanofi initiated a phase III LIBERTY-CSU/CINDU CUPIDKids trial to evaluate the pharmacokinetics and safety of dupilumab in children age 2-11 years with chronic spontaneous urticaria and chronic cold urticaria who remained symptomatic despite the use of H1-antihistamine treatment and/or appropriate preventive measures (PKM16982; NCT05526521; EudraCT2022-000260-22; U1111-1266-5669). The multi-center, single-arm trial is designed to enroll approximately 24 patients in the US, Canada, Japan [236] .

In February 2022, Sanofi released data from the phase-III trial (CUPID STUDY B) [237] .

In July 2021, Regeneron Pharmaceuticals announced that the study met its primary and all secondary end points [238] [239] . In November 2019, Sanofi initiated a phase III CUPID (LIBERTY-CUPID) trial to evaluate the efficacy of duplimab in patients with chronic spontaneous urticaria who remained symptomatic despite the use of H1 antihistamine (EFC16461; NCT04180488; EudraCT2019-003775-19; U1111-1241-8208). The randomised, double-blind, multi-center and placebo-controlled trial is designed to enrol 384 patients in the US, Argentina, Canada, Germany, France, Hungary, Japan, China, Russia, Spain and the UK [240] . In July 2021, Sanofi and Regeneron Pharmaceuticals released safety,immunogenicity and efficacy data from this trial809330875. In February 2022, Top-line efficacy, immunogenicity and safety data from the trial were presented at the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) Annual Meeting [241] . In February 2022, the company presented updated efficacy and safety data from the trial at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [242] . In April 2023, the company presented updated efficacy data at American Academy of Allergy, Asthma and Immunology annual meeting 2023 (AAAAI-2023) [243] . In February 2024, results from this trial were presented at Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024) [244]

In April 2023, Sanofi completed the phase III LIBERTY-CINDU CUrIADS clinical trial (NCT04681729; EudraCT2020-003756-33). As of April 2023, the phase III LIBERTY-CINDU CUrIADS trial did not meet the required efficacy endpoints and the development has been discontinued in chronic cold induced urticaria [1] . In December 2020, Sanofi and Regeneron initiated the phase III LIBERTY-CINDU CUrIADS trial to demonstrate the efficacy of dupilumab in patients with primary acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of an H1-antihistamine (NCT04681729; EudraCT2020-003756-33). The randomsied trial intends to enrol approximately 78 patients in the US, Germany, Argentina, Canada and Japan [245] [233] .

In October 2020, Sanofi announced its intention to initiate a phase III trial in urticarial (Urticaria-Cold) either late in 2020 or early 2021 [246] .

In July 2021, Sanofi-Aventis Deutschland GmbH and Charité - Universitätsmedizin Berlin Klinik für Dermatologie und Allergologie completed a phase II trial that evaluated the efficacy and safety of Dupilumab in patients with chronic urticaria despite H1-antihistamine treatment (EudraCT2017-004458-41 ; NCT03749135). The randomized, double-blinded, placebo controlled trial was initiated in November 2018 and enrolled 72 patients in Germany [247] .

Eosinophilic asthma

Regeneron and Sanofi have completed a phase II clinical trial which assessed the efficacy, safety and tolerability of subcutaneous dupilumab in patients with persistent, moderate-to-severe eo sinophilic asthma who were partially controlled or uncontrolled by inhaled corticosteroids plus long-acting β-agonist treatment (ACT11457; U1111-1117-7826; NCT01312961). Dupilumab was administered once-weekly, on top of fluticasone/salmeterol during the background therapy stable phase, and on top of fluticasone during the background therapy withdrawal phase. The primary outcome measure was the number of patients experiencing an asthma exacerbation over 12 weeks. This randomised, double-blind, placebo-controlled trial enrolled 104 patients in the US and was completed in October 2012 [248] . Positive results were presented at the 109th International Conference of the American Thoracic Society (ATS-2013) [249] [250] .

Allergic asthma

In December 2019, Regeneron Pharmaceuticals and Sanofi completed a phase I trial designed to evaluate the efficacy of dupilumab, REGN 3500 [See ADIS Insight Drug profile 800048225], REGN 3500 and dupilumab compared with placebo, on inflammatory gene expression after a bronchial althelergen challenge (BAC) in adults with mild allergic asthma (NCT03112577; EudraCT2016-003165-26; R3500AS1633; SAR440340). The double-blind, parallel, prospective, randomised trial, initiated in June 2017 enrolled 32 patients in the US and the UK [251] .

Bullous pemphigoid

In August 2019, the US FDA granted orphan drug designation to dupilumab for the treatment of bullous pemphigoid [252] [253] .

As of October 2023, Regeneron Pharmaceuticals in collaboration with Sanofi resumed the availability of dupilumab in an expanded access program in adult patients with bullous pemphigoid that participated in the R668-phase II/III BP-1902 trial [see below]. Earlier in June 2023, Regeneron Pharmaceuticals temporarily suspended the expanded access program of dupilumab in adult patients with bullous pemphigoid (NCT05906706; R668-BP-2290-EAP). Previously, the open-label, expanded access program was temporarily not available [254] .

As at February 2020, dupilumab was in a phase III trial for the treatment of bullous pemphigoid [34] [255] .

In October 2020, Regeneron Pharmaceuticals in collaboration with Sanofi initiated a phase II/III LIBERTY-BP trial to evaluate the efficacy and safety of dupilumab in adult patients with Bullous Pemphigoid (EudraCT2019-003520-20; NCT04206553; R668BP1902). The randomised, double blind trial intends to enrol 98 patients in the France, Germany, Australia, Japan, and in the US [256] .

Eosinophilic gastroenteritis

In May 2023, Regeneron Pharmaceuticals in collaboration with Sanofi initiated the phase II/III ENGAGE trial to investigate the efficacy and safety of dupilumab in eosinophilic gastroenteritis (NCT05831176; R668-EGE-2213; 2022-500795-62-00). The randomized trial intends to enroll 279 patients in the US, Australia, Italy and Poland. In February 2024, results from this trial were presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024) [1] [257] [258]

In May 2021, Regeneron Pharmaceuticals in collaboration with National Institutes of Health and Children's Hospital Medical Center, Cincinnati, initiated a phase II trial to evaluate the efficacy of repeat subcutaneous doses of dupilumab in patients with eosinophilic gastritis (IRB 2020-0798; NCT03678545). The randomised, double-blind, placebo-controlled trial intends to enrol approximately 40 participants in the US [259] .

Eosinophilic oesophagitis

In January 2024, Regenron Pharmaceuticals and Sanofi announced that the US FDA has approved dupilumab (Dupixent®) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). The approval is based on data from the phase III EoE KIDS trial (see below) [260] [261] . In September 2023, the US FDA has accepted the supplemental Biologics License Application (sBLA) for for Priority Review for dupilumab to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE). The sBLA is supported by data from the Phase 3 EoE KIDS trial (Parts A and B) evaluating the efficacy and safety of Dupixent in children aged 1 to 11 with EoE [See below]. In Part A, the primary endpoint was met for the proportion of patients achieving histological disease remission (defined as peak esophageal intraepithelial eosinophil count of =6 eosinophils [eos]/high power field [hpf]) at 16 weeks for tiered dosing regimens based on body weight, compared to placebo. The target action date for the FDA decision has been decided as January 31, 2024 [262] [221] .

In February 2024, Regeneron Pharmaceuticals anticipates decision on regulatory submission for Dupixent for eosinophilic esophagitis in children (1–11 years of age)in second half of 2024. A regulatory application has also been submitted in the EU (paediatric) [221] .

As of October 2022, dupilumab (Dupixent®) is available in the US for the treatment of eosinophilic esophagitis (EoE) [19] . In May 2022, the US FDA approved dupilumab (Dupixent®) 300mg weekly to treat patients with eosinophilic esophagitis (EoE), aged 12 years and older, weighing at least 40kg. The approval granted more than two months ahead of FDA's Priority Review action date. The approval was based on data from a phase III trial with two parts (Part A and Part B), evaluating the efficacy and safety of dupilumab 300mg weekly, compared with placebo [see trial below] [263] . Earlier, in March 2022, the US FDA accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent®) 300mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis. The target action date for the FDA decision on this investigational use is August 3, 2022. The sBLA was supported by data from two phase III trials, evaluating the efficacy and safety of dupilumab 300mg weekly [264] .

Dupilumab (Dupixent®) is available in Denmark, Sweden, France, Austria, Spain, Netherlands, Hungary, Germany, Czech Republic, Poland, and Ireland. In January 2023, The European Commission (EC) expanded the marketing authorization for dupilumab in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, intolerant to, or are not candidates for conventional medicinal therapy. The approval was based on Results from phase III trial consisting of three parts (Part A, B and C) (see below) [265] .

In May 2023, Health Canada issued a notice of compliance for DUPIXENT® (dupilumab injection) for the treatment of patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE). The application was based on the phase III LIBERTY-EoE-TREET trial (see below) consisting of parts A and B [266] .

In December 2022, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the approval of Dupixent® (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE) [267] . In May 2022, regulatory application was submitted in the EU for dupilumab (Dupixent®) 300mg weekly to treat adult and pediatric patients, aged 12 years and older, with eosinophilic esophagitis [12] .

Before November 2021, Regeneron Pharmaceuticals announced initiation of rolling supplemental Biologics License Application (sBLA) for adults and adolescents with Eosinophilic oesophagitis [238] .

In September 2020, the USFDA granted Breakthrough Therapy designation to dupilumab for the treatment of patients 12 years and older with eosinophilic esophagitis. The designation was based on positive results from part A of pivotal phase III trial (see below).

In October 2017, the US FDA granted orphan drug designation to dupilumab for the treatment of moderate to severe eosinophilic oesophagitis [268] .

In October 2022, safety and adverse events data from the trial in eosinophilic esophagitis were presented at the United European Gastroenterology Week (UEGW-2022) the trial met their primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens [269] [270] . Earlier, in September 2020, Regeneron in collaboration with Sanofi initiated the phase III EoE KIDS trial to evaluate the efficacy and safety of dupilumab in pediatric patients with eosinophilic esophagitis (NCT04394351; R668-EE-1877; EudraCT2019-003078-24). The randomised trial enroled 102 patients in the US and Canada [271] . In July 2022, the company released positive results from the trial with primary endpoint being met [272] . In October 2023, updated results were released by the company [273] . In January 2024, company released updated efficacy and adverse events data from the trial [261] . In March 2024, updated data from the phase III study was presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024) [274] [275] .

In June 2022, Regeneron Pharmaceuticals completed a pivotal phase III LIBERTY-EoE-TREET/LIBERTY TREET trial of dupilumab in the treatment of patients with eosinophilic oesophagitis. Earlier, in October 2021, the company announced that the phase III part B study met its co-primary endpoints. In May 2020, Sanofi and Regeneron Pharmaceuticals announced positive results from part A of the pivotal phase III trial, evaluating the safety and efficacy of dupilumab treatment in adult and adolescent patients with eosinophilic oesophagitis (R668EE1774; EudraCT2018-000844-25; NCT03633617). The company also reported that the trial met both of its co-primary endpoints, as well as all key secondary endpoints. The randomised trial was initiated in September 2018, and enrolled 321 patients in Australia, Belgium, Canada, France, Germany, Italy, the Netherlands, Portugal, Spain, Sweden, Switzerland, the UK and the US. Part A enrolled 81 patients and evaluated dupilumab 300mg weekly (42 treated with dupilumab and 39 with placebo). Part B enrolled 240 patients and evaluated dupilumab 300mg weekly (80 with dupilumab and 79 with placebo). The trial has also expanded in a 28-week extended active treatment period (Part C) after completing either Part A or Part B, which enrolled 77 patients. In October 2020, Sanofi release updated results from the Part A of the trial. In October 2020, adverse events and safety data from a phase III part A trial in eosinophilic esophagitis were presented at the 28th United European Gastroenterology Week (UEGW-2020). In February 2021, the company presented results from Part A of a randomised, placebo-controlled trial at Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021). In October 2021, the company released updated efficacy and safety results of phase III part B of the trial. In February 2022, the company presented efficacy and safety results from the trial at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2022). In August 2022, the company released updated efficacy and safety results from part B of a phase III trial [276] [277] [278] [238] [279] [280] [281] [282] [279] [227] [283] [284] . In November 2022, company presented pooled data form both cohort A and B at 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2022) [285] . In February 2023, the company presented updated efficacy results from the trial at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (ACAAI-2023) [286] . In May 2023, results from this trial were presented at the Digestive Disease Week 2023 (DDW-2023) [287] [288] [289] . In October 2023, the Company presented additional efficacy data at the 31st United European astroenterology Week (UEGW-2023) [290] . In October 2023, the company presented additional data at the 31st United European Gastroenterology Week (UEGW-2023) [291] .

In July 2017, Regeneron in collaboration with Sanofi completed a phase II proof-of-concept trial that evaluated the efficacy, safety and tolerability of repeat subcutaneous doses of dupilumab, in patients with active, moderate to sev ere eosinophilic oesophagitis (NCT02379052; R668-EE-1324). The double-blind, placebo-controlled, randomised, parallel trial was initiated in January 2015, and enrolled 47 patients in the US [25] [292] . In October 2017, Sanofi and Regeneron Pharmaceuticals released positive efficacy and safety data for the trial. The primary analysis for the trial was completed in March 2017 [268] .

Eczema

In August 2020, University Medical Center Groningen in collaboration with Sanofi initiated a phase II DUPSHE trial to evaluate the efficacy of dupilumab in hand eczema patients with an inadequate response or intolerance to alitretinoin (EudraCT2019-001561-32; 201900237; NCT04512339). The open-label phase II trial enrolled 30 patients in the Netherlands [293] . As of May 2023, the company completed enrollment for the trial [294] .

Grass pollen hypersensitivity

Prior to March 2021, development for dupilumab for grass pollen hypersensitivity was discontinued [295] .

In June 2019, Regeneron completed a phase II trial that assessed whether 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom Score (TNSS) after nasal allergen challenge (NAC) with timothy grass extract at week 17 (NCT03558997; R668ALG16115). The double-blind, parallel, randomised trial was initiated in June 2018 and enrolled 103 patients in the US and Canada [296] .

Peanut hypersensitivity

As of July 2022, the development of dupilumab in peanut hypersensitivity was discontinued [2] .

In May 2021, Regeneron Pharmaceuticals completed a phase II trial which assessed the efficacy and safety of dupilumab administered as a monotherapy, subcutaneously, in paediatric patients with peanut allergy (R668-ALG-1702; NCT03793608; EudraCT2018-003133-15). The randomised, parallel trial was initiated in in March 2019 and enrolled 25 participants (aged 6-17 years) in the US and Canada [297] .

In July 2021, Aimmune Therapeutics completed a phase II trial, with Sanofi and Regeneron, tha t assessed the efficacy and safety of dupilumab as adjunct to AR 101-Characterized Oral Desensitization Immunotherapy (CODIT) in peanut-allergic patients (R668-ALG-16114; NCT03682770). The randomised 2:1, double-blind, placebo-controlled trial that was initiated in October 2018 enrolled 149 patients (aged 6 to 17 years) in the US [138] [298] [299] .

Prostate cancer

In October 2020, Regeneron Pharmaceuticals terminated a phase II trial designed to evaluate the safety, anti-tumour activity and immungenicity of neoadjuvant dupilumab, given prior to prostatectomy in patients with high-risk prostate cancer due to low accrual owing to COVID-2019 pandemic (J18116; IRB00182718; NCT03886493). The single-center, single arm, open-label was initiated in July 2019 and intended to enrol approximately 20 patients in the US [300] .

Chronic rhinosinusitis with nasal polyposis (CRSwNP)

(Rhinosinusitis): In June 2021, Sanofi Canada announced that a 300 mg single-dose (single-use) pre-filled pen for dupilumab injection (DUPIXENT®) is available in Canada. The pre-filled pen is approved for all DUPIXENT® indications in patients aged 12 years and older with severe chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration [16] .

In June 2019, the US FDA approved dupilumab as an add-on maintenance treatment in adult patients with nasal polyps, accompanied by chronic rhinosinusitis. The product was launched subsequently. The sBLA was submitted earlier, in December 2018, by Regeneron and Sanofi. It was accepted in March 2019 by the US. Both, the application and eventual approval, were supported by data from two pivotal phase III trials [see below] evaluating the efficacy and safety of dupilumab, when combined with standard-of -care corticosteroid nasal spray in 724 evaluable patients, with recurring severe chronic rhinosinusitis with nasal polyps [301] [302] [303] [304] .

In October 2019, the European Commission approved dupilumab and recommended dupilumab as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Earlier in September 2019, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for dupilumab. The positive CHMP opinion was based on two pivotal phase III trials, the 24-week SINUS-24 and 52-week SINUS-52 trials (see below) [305] [306] . In May 2019, Regeneron and Sanofi announced the submission of a European Marketing Authorization Application (MAA) for chronic rhinosinusitis with nasal polyps [307] .

In August 2020, Sanofi Canada announced that the Health Canada approved a dupilumab injection (DUPIXENT®), as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery. The approval was based on two pivotal phase III trials, including the 24-week SINUS-24 trialand 52-week SINUS-52 trial [308] .

In March 2020, the MHLW approved dupilumab for chronic rhinosinusitis with nasal polyposis (CRSwNP) in Japan [309] . In September 2019, Regeneron and Sanofi announced submission of marketing approval application of dupilumab as an add-on therapy with intranasal corticoste roids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP), in Japan [310] .

In May 2023, Sanofi initiated a phase III trial to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy with intranasal corticosteroids (budesonide nasal spray) (NCT05878093; EFC17026; U1111-1256-9711). The randomised, double-blind, placebo-controlled trial intends to enrol approximately 62 patients in China [311] .

In May 2020, Regeneron Pharmaceuticals presented updated pooled efficacy data from the two phase III SINUS-24 and SINUS-52 trials at 116th International Conference of the American Thoracic Society (ATS-2020) [312] . Earlier in March 2020, company presented updated pooled efficacy data from the two phase III SINUS-24 and SINUS-52 trials (see below), in patients with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2020). In May 2019, pooled data from these phase III trials, was presented at the 115th International Conference of the American Thoracic Society (ATS-2019). Earier in February 2019, Regeneron Pharmaceuticals released positive results from the trial [313] [314] [315] [310] . In May 2021, the company presented pooled results of the two phase III SINUS-24 and SINUS-52 trials at the 117th International Conference of the American Thoracic Society (ATS-2021) [316] [317] [318] [319] .

In November 2018, Regeneron and Sanofi completed the SINUS-52 phase III pivotal trial. The trial met all its primary and secondary endpoints in October 2018. The trial was initiated in November 2016, by Sanofi-Aventis to assess the efficacy and safety of dupilumab in patients with bilateral nasal polyps treated with intranasal corticosteroids (EFC14280; EudraCT2015-001314-10; U1111-1170-7180; NCT02898454).The randomised, double-blind, placebo-controlled trial enrolled 448 patients in the US, Australia, Belgium, Canada, Chile, J apan, Portugal, Russia, Spain, Argentina, Israel, Mexico, Turkey and Sweden. Later, in September 2019, pooled analysis data from two phase III trials, including the SINUS-24 [see trial below] and SINUS-52 trials was presented at the 29th Annual Congress of the European Respiratory Society (ERS-2019). In March 2020, the company presented safety data at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2020) [320] [321] [322] [323] [319] . In April 2021, the company presented efficacy data at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021) [324] . In September 2022, Efficacy data from a phase III trial in Nasal-polyps presented at the 32nd Annual Congress of the European Respiratory Society(ERS- 2022) [325] .

In October 2018, Regeneron and Sanofi reported that the phase III pivotal trial SINUS-24 met all its primary and secondary endpoints. The trial that assessed the efficacy and safety of dupilumab 300mg every other week, in patients with bilateral nasal polyps treated with intranasal corticosteroids was completed in July 2018 (NCT02912468; EudraCT2015-003101-42; UKCRN30597; EFC14146; U1111-1178-5390). The double-blind, placebo-controlled, randomised trial was initiated in December 2016, and enrolled 276 patients in the US, Bulgaria, Czech Republic, France, Germany, Romania, Poland, Russia, Netherlands, Italy, Ukraine, the UK and Hungary [323] [318] . In March 2020, the company presented efficacy and safety data at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2020). Dupilumab was generally well tolerated [326] .

Sanofi, in collaboration with Regeneron, completed a randomised, double-blind, placebo-controlled phase IIa trial in November 2014, which assessed subcutaneous dupilumab in patients with nasal polyposis and chronic symptoms of sinusitis (NCT01920893; EudraCT2013-001803-35). Dupilumab was given in combination with intranasal mometasone furoate spray for 16 weeks. The trial enrolled 60 patients in the US, Belgium, Sweden and Spain [212] . Positive top-line results have been reported [327] [328] [329] . Updated results were presented at the 26th Annual Congress of the European Respiratory Society (ERS-2016) [330] [331] .

Chronic rhinosinusitis without nasal polyps (CRsNP)

(Rhinosinusitis): In October 2023, Sanofi initiated a phase III trial named ADAPT to study the safety and efficacy of Dupilumab 300mg in patients with allergic fungal rhinosinusitis (AFRS) on a background therapy with intranasal corticosteroid spray after endoscopic sinus surgery (NCT05545072; STUDY00000090). The randomized trial intends to enroll approximately 132 participants in the US [332] .

In December 2020, Sanofi in collaboration with Regeneron Pharmaceuticals initiated a phase III to assess the efficacy and safety of dupilumab in patients with allergic fungal rhinosinusitis (AFRS) (EFC16724; U1111-1246-7549; EudraCT2020-002999-12; NCT04684524). The randomised, double-blind, placebo-controlled trial intends to enrol approximately 120 patients in the US.

In January 2024, Sanofi and Regeneron Pharmaceuticals completed a phase II/III Liberty CRSsNP study which was designed to assess the safety and efficacy of dupilumab in patients with uncontrolled, chronic rhinosinusitis without nasal polyposis (CRSsNP) (NCT04678856, EFC16723, EudraCT2020-003117-35). The randomised, double blind, parallel, placebo controlled, multicenter study was initiated in December 2020 and enrolled 71 patients in Canada, Sweden, United Kingdom, Argentina, Belgium, Chile, China, Hungary, South Korea, Portugal, Russia, Spain [333] .

Milk hypersensitivity

In September 2021, Regeneron Pharmaceuticals initiated a phase II trial to evaluate the efficacy and safety of dupilumab and milk oral immunotherapy for the treatment of patients with cow's milk allergy (milk hypersensitivity in development table) (IRB-52976; NCT04148352). The randomised, double-blind, placebo-controlled trial intends to enroll approximately 116 patients in the US [334] [101] .

Urticaria

In February 2023, Charite University in collaboration with Sanofi and Proinnovera GmBH completed a phase II trial which evaluated the efficacy and safety of dupilumab in patients with cholinergic urticaria despite H1-antihistamine treatment (D-001-02; EudraCT2017-001262-25; NCT03749148). The randomized, double blind, placebo controlled study was initiated in December 2018 and enrolled 48 participants in Germany [335]

Prurigo nodularis

In June 2023, the Ministry of Health, Labour and Welfare (MHLW) approved dupilumab for the treatment of adult patients with prurigo nodularis in Japan [223] .

In December 2022, the European Commission (EC) approved dupilumab (Dupixent®) for the treatment of adult patients with prurigo nodularis in the European Union, Lichenstein, Norway and Iceland. The EC decision was based on the data from two phase III PRIME2 and PRIME trials (see below) evaluating the efficacy and safety of dupilumab in patients 18 years and older for treatment of prurigo nodularis [336] [337] .

In September 2022, the US FDA launched and approved dupilumab (Dupixent®) for the treatment of adult patients with prurigo nodularis in the US [338] . Earlier in May 2022, Regeneron Pharmaceuticals and Sanofi reported that the US FDA had accepted for priority review the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent®) to treat adults with prurigo nodularis. The target action date for the FDA decision is September 30, 2022. The sBLA was supported by data from two phase III PRIME2 and PRIME trials (see below) evaluating the efficacy and safety of dupilumab in patients 18 years and older for treatment of prurigo nodularis [339] .

In November 2022, European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, recommending the approval of dupilumab (Dupixent®) in the European Union (EU) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. The positive opinion is based upon data from two phase III PRIME and PRIME2 trials (see below) [340] . As of August 2022, Regeneron Pharmaceuticals reported that the regulatory applications for dupilumab in the treatment of prurigo nodularis have been submitted in the European Union (EU) [341] [342] .

As of September 2022, Sanofi plans to submit regulatory application worldwide for approval of dupilumab in prurigo nodularis in 2022. Results from the two phase III PRIME2 and PRIME trials [see below] will form the basis of regulatory submissions [342] .

As of August 2022, Regeneron Pharmaceuticals reported that the regulatory applications for dupilumab in the treatment of prurigo nodularis has been submitted in Japan [341] [342] .

In March 2023, Regeneron Pharmaceuticals presented pooled efficacy data from two phase III PRIME and PRIME2 trials (see below) in patients with prurigo nodularis at American Academy of Dermatology annual Meeting 2023 (AAD-2023) [343] [344] . In September 2022, Regeneron Pharmaceuticals released pooled adverse event data from two phase III PRIME and PRIME2 trials (see below) in patients with prurigo nodularis [338] [345] [346] .

As of January 2022, the phase III PRIME trial met its primary and key secondary endpoints, showing that dupilumab significantly reduced itch and skin lesions compared to place bo at 24 weeks in this investigational setting. In February 2022, Sanofi and Regeneron Pharmaceuticals completed the phase III PRIME trial that evaluated the efficacy of dupilumab on itch response in patients with prurigo nodularis, inadequately controlled on topical prescription therapy or when those therapies are not advisable (EFC16459; NCT04183335; U1111-1241-8153; EUDRACT2019-003774-41). The double-blind, parallel, prospective, randomised trial was initiated earlier in December 2019, and enrolled 175 patients in the the US, Argentina, China, France, Hungary, Japan, South Korea, Mexico, Russia [345] . In January 2022, positive efficacy data from the trial were released by Regeneron Pharmaceuticals [347] .

In October 2021, Regeneron Pharmaceuticals reported met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo [238] [348] . Sanofi and Regeneron Pharmaceuticals, in November 2021, Regeneron Pharmaceuticals completed the phase III PRIME2 trial which was evaluated efficacy and safety of dupilumab in patients with prurigo nodularis who are inadequately controlled on topical prescription therapies or when those therapies are not advisable (NCT04202679; EFC16460; Eudra CT 2019-003801-90; U1111-1241-8174 ). The primary endpoint of the trial is to determine improvement (reduction) in worst-itch numeric rating scale (WI-NRS) by ≥4 from baseline to week 12. The randomised, double blind, placebo-controlled trial initiated in December 2019 and enrolled 160 patients aged 18-80 years in Canada, Chile, England, France, Hungary, Italy, Portugal, South Korea, Spain, Taiwan, United Kingdom and the US [346] . In October 2021, efficacy and safety data for the PRIME2 phase III trial in prurigo nodularis released by the company [348] .

Pruritus

In January 2022, Sanofi initiated the phase III trial LIBERTY-CPUO-CHIC to evaluate the safety and efficacy of dupilumab for the treatment of adult patients with chronic pruritus of unknown origin (CPUO) (EFC16973; EudraCT2021-004315-76; U1111-1253-9888). The randomised, double blind and placebo-controlled trial intends to enrol approximately 453 patients in Italy and Hungry [349] .

Ulcerative Colitis

In January 2023, Sanofi initiated a phase II LIBERTY-UC SUCCEED trial to evaluate the efficacy and safety of dupilumab therapy in patients with moderately to severely active ulcerative colitis with an eosinophilic phenotype (ACT17746; ICTRPU1111-1278-4042; NCT05731128). The multi-center, randomised, double-blind, placebo-controlled, parallel-group study intends to enrol approximately 100 participants in the US, Japan and South Korea [350] .

In September 2020, Regeneron Pharmaceuticals, in collaboration with Mayo Clinic, initiated a phase II trial to assess the efficacy of subcutaneously administered dupilumab for the treatment of moderate to severe chronic hepatic pruritus (19-002757; NCT04256759). The 22-week, open-label, exploratory study intends to enrol approximately 12 patients in the US [351] .

Volunteer studies

In September 2021, Sanofi completed a phase I trial which was designed to compare the pharmacokinetics of new and current dupilumab drug products subcutaneously administered in healthy adults (NCT05976386; PKM17324; U1111-1266-7002). The randomized, open-label trial was initiated in June 2021 and enrolled 182 in the US [352]

In March 2015, Sanofi completed a phase I study that evaluated safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers (NCT05976373; PKM14271). The randomsied, open label trial initiated in January 2015 enrolled 38 volunteers in US [353] .

In March 2012, Regeneron and Sanofi completed a phase I trial to evaluate the safety, tolerability and immunogenicity of subcutaneously administered dupilumab in 36 healthy volunteers (NCT01484600). This open-label study was conducted in the US [354] .

In January 2015, Regeneron Pharmaceuticals and Sanofi completed a phase I pharmacokinetics trial which evaluated the safety and pharmacokinetics of 2 different dupilumab drug product in healthy volunteers (NCT05976360; PKM14161; U1111-1290-9436 ). The randomized, open-label trial enroled 38 volunteers in the US [355] .

Sanofi and Regeneron conducted a phase I clinical trial to assess the tolerability, pharmacokinetics and pharmacodynamics of subcutaneous dupilumab in healthy male volunteers in Japan (NCT01537653). The trial enrolled 32 patients and was completed in October 2012 [356] .

A phase I trial, completed in mid-2012 by Regeneron and Sanofi, assessed the pharmacokinetic profiles of two different subcutaneous formulations of dupilumab in 30 healthy volunteers in the US (NCT01537640) [357] .

A phase I clinical trial assessing the safety and tolerability and intravenous dupilumab, compared with placebo, in healthy volunteers has been completed (NCT01015027) [358] . This trial, initiated in October 2009, enrolled 48 volunteers in the US [359] .

Patent Information

As of February 2023, Regeneron Pharmaceuticals has patent protection for formulations and methods of treatment for dupilumab in US with the patent numbers 9 238 692 11 421 036, 10 137 193, 11 214 621 and 11 292 847 with their respective expiration dates being October 2031, July 2034, March 2036 and May 2039 respectively [45]

As of February 2023, Regeneron Pharmaceuticals has patent protection for methods of treatment for dupilumab in Europe with the patent number 3 019 191. The patent has an expiration date of July 2034 [45]

As of February 2023, Regeneron Pharmaceuticals has patent protection for methods of treatment for dupilumab in Japan with the patent number 7 164 530. The patent has an expiration date of September 2037 [45]

As of December 2022, Sanofi has patent protection till October 2027 (March 2031 with PTE) in the US, in the EU till October 2029 (September 2032 with SPC) and in Japan till October 2029 (May 2034 with PTE). The company has later filled patents coverage ranging through October 2041 for US and August 2040 for EU and Japan. With regulatory exclusivity till March 2029, in the US. For the EU September 2027 and January 2026 for Japan [360] .

As of December 2021, Regeneron Pharmaceuticals has one composition of matter patent (5 291 802), valid until October 2029 (subjected to extension till October 2034); One formulation patent (5 918 246), valid until October 2031 (subjected to extension until September 2034); five methods of treatment patents, 6 306 588, 6 353 838, 6 673 840, 6 463 351, 6 861 630, valid until August 2033 (subjected to extension till August 2034), September 2033, February 2035, June 2034, and November 2035 respectively, in Japan [361] .

As of December 2021, Regeneron Pharmaceuticals has supplementary protection certificate for patent 2356151, valid till September 2032; four methods of treatment patents (2888281, 3064511, 3107575 and 3470432), valid until August 2033, October 2029, February 2035, and August 2033 respectively; and one formulation patent (3354280), valid until October 2031, in the EU [361] .

As of December 2021, Regeneron Pharmaceuticals has two formulation patents (10 435 473 and 11 059 896), valid till October 2031; two methods of treatment patent (11 167 004 and 11 034 768) valid till September 2037 and March 2039 respectively, in the US [361] .

Prior to December 2020, Regeneron Pharmaceuticals two additional methods of treatment related patents in the US (10 485 844 and 10 059 771) valid until September 2037 and June 2034, respectively. Dupilumab is also covered under one formulation related patent (2 624 865) and a methods of treatment patent (3 010 539) in the EU which is expected to expire in October 2031 and June 2034, respectively [362] .

As at February 2018, Regeneron Pharmaceuticals reported that it has composition of matter patents covering dupilumab in the US (7 608 693) and the EU (2 356 151) that will expire in October 2027 and October 2029, respectively. Dupilumab is also covered under one formulation related patent in the US (8 945 559) which is expected to expire in October 2032 and four methods of treatment related patents in the US (8 075 887, 8 337 839, 9 290 574 and 9 574 004) that are set to expire in April 2020, October 2027, July 2034 and December 2033, respectively [363] .

Patent disputes

In February 2019, Regeneron Pharmaceuticals announced that the Opposition Division of the European Patent Office (EPO) invalidated and revoked Immunex's European Patent No. 2,990,420 in its entirety as the claims were invalid for insufficiency of disclosure. The announcement followed the decision by the Patent Trial and Appeal Board (PTAB) of the U.S. Patent & Trademark Office (USPTO) to invalidate all 17 claims of Immunex's U.S. Patent No. 8,679,487 as obvious. These decisions are subject to appeal by Immunex. EPO decision follows a ruling in November 2017 (published in January 2018), invalidating a similar Immunex European patent also claiming antibodies that target human IL-4R. Earlier in March 2017, Regeneron and Sanofi had pre-emptively sued Amgen for a declaratory judgement that Dupixent® does not infringe Amgen’s patent, U.S. Patent No. 8,679,487 and had filed an IPR against the ‘487 Patent. In response, Amgen sued Regeneron for infringement of its ‘487 patent in April 2017 [364] .

Dupilumab has patent protection until 2027 in the US and until 2029 in the the EU and Japan (Sanofi 20-F, March 2014).

The regulatory exclusivity period for the patents in US, EU and in Japan is March 2029, September 2027 and January 2026 respectively [365] .

Drug Properties & Chemical Synopsis

  • Route of administration IV, SC
  • Formulation Injection, unspecified
  • Class Anti-inflammatories, Antiallergics, Antiasthmatics, Antifungals, Antineoplastics, Antipruritics, Immunotherapies, Monoclonal antibodies, Skin disorder therapies
  • Target Interleukin 13 receptor; Interleukin 4 receptor
  • Mechanism of Action Interleukin 13 receptor antagonists; Interleukin 4 receptor antagonists
  • WHO ATC code

    A07E (Intestinal Antiinflammatory Agents)

    D04A-X (Other antipruritics)

    D11A-H05 (Dupilumab)

    D11A-X (Other dermatologicals)

    L01X (Other Antineoplastic Agents)

    L04A-C (Interleukin inhibitors)

    R01 (Nasal Preparations)

    R03D-X (Other systemic drugs for obstructive airway diseases)

    R07 (Other Respiratory System Products)

    V01A-A08 (Food)

  • EPhMRA code

    A7E (Intestinal Anti-Inflammatory Agents)

    D11A (Other Dermatological Preparations)

    D4A (Anti-Pruritics, Including Topical Antihistamines, Anaesthetics, etc)

    L1X (All Other Antineoplastics)

    L4X (Other Immunosuppressants)

    R1B (Systemic Nasal Preparations)

    R3X2 (All other anti-asthma and COPD products, systemic)

    R7 (Other Respiratory System Products)

    V1A (Allergens)

  • Chemical name Immunoglobulin, anti-(human interleukin 4 receptor α) (human REGN668 heavy chain), disulfide with human REGN668 κ-chain, dimer
  • Molecular formula C6512 H10066 N1730 O2052 S46
  • CAS Registry Number 1190264-60-8

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

adenocarcinoma

Detailed Description

PSA

1

adenocarcinoma

Eligibility Criteria

Alkaline phosphatase (ALPL)

1

adenocarcinoma

Outcome Measure

T-cell surface antigen CD4

T-Cell differentiation antigen CD8

PSA

Nuclear protein Ki67

mannose receptor, C type 1

Deoxyuridine triphosphate

Annexin A5

5 more biomarker names

Show less

1

1

1

1

1

1

1

allergic asthma

Outcome Measure

interleukin 33

1

allergic bronchopulmonary aspergillosis

Brief Title

filamin C, gamma

1

allergic bronchopulmonary aspergillosis

Outcome Measure

immunoglobulin heavy constant epsilon

1

anosmia

Brief Summary

TLX1 neighbor

1

asthma

Arm Group Label

transcription factor Dp-1

1

asthma

Outcome Measure

T-cell surface antigen CD4

T-cell receptor T3 delta chain (CD3d)

T-cell receptor CD3-epsilon (CD3e)

PGD2

mucin 5AC, oligomeric mucus/gel-forming

Leukotriene E4

interleukin 25

immunoglobulin heavy constant epsilon

Human Microbiome

chymase 1

CD3 gamma chain (CD3G)

CCL17

BCAR1, Cas family scaffolding protein

alpha-1 antitrypsin (SERPINA1)

12 more biomarker names

Show less

1

1

1

1

1

1

1

4

1

1

1

2

1

1

asthma

Brief Title

Human Microbiome

filamin C, gamma

1

1

asthma

Arm Group Description

Tubulin beta class IVb

Fluticasone

1

1

asthma

Detailed Description

Nitric Oxide (NO)

Interleukin-13 (IL-13)

1

1

asthma

Official Title

Tubulin beta class IVb

interleukin 4 receptor

Human Microbiome

1 more biomarker names

Show less

1

1

1

asthma

Brief Summary

interleukin 4 receptor

1

atopic dermatitis

Outcome Measure

Tumor necrosis factor alpha (TNF-alpha)

Treacher Collins-Franceschetti syndrome 1

thymic stromal lymphopoietin

tachykinin, precursor 1

T-cell surface antigen CD4

T-Cell differentiation antigen CD8

Substance P

selectin P ligand

Melatonin

Interleukin-8 (IL-8)

Interleukin-6 (IL-6)

Interleukin-5 (IL-5)

Interleukin-4 (IL-4)

Interleukin-3 (IL-3)

Interleukin-17 (IL-17)

Interleukin-13 (IL-13)

Interleukin-10 (IL-10)

Interleukin 1 Beta (IL-1β)

immunoglobulin heavy constant epsilon

IL31

FLG

Eotaxin (CCL11)

eosinophil peroxidase

CRLF2

CD45 (leukocyte common antigen)

CCL17

C-C motif chemokine ligand 27

25 more biomarker names

Show less

1

1

2

1

2

1

1

1

1

1

1

1

4

1

1

2

1

1

3

1

1

1

1

1

1

2

2

atopic dermatitis

Brief Title

Human Microbiome

1

atopic dermatitis

Arm Group Description

cytochrome P450 family 2 subfamily B member 6

1

atopic dermatitis

Detailed Description

immunoglobulin heavy constant epsilon

FLG

CCL17

1 more biomarker names

Show less

1

1

1

atopic dermatitis

Eligibility Criteria

Interferon Gamma (IFNg)

immunoglobulin heavy constant epsilon

FSH

CYP3A4

CYP2D7

CYP2D6

CYP2C9

CYP2C19

CYP1A2

B-lymphocyte antigen CD19

8 more biomarker names

Show less

1

1

1

1

1

1

1

1

1

2

atopic dermatitis

Official Title

Interleukin-4 (IL-4)

Interleukin-13 (IL-13)

Human Microbiome

cytochrome P450 family 2 subfamily B member 6

2 more biomarker names

Show less

1

1

1

1

bullous pemphigoid

Brief Summary

BP230

BP180

1

1

bullous pemphigoid

Eligibility Criteria

HEAT repeat containing 5B

CUX1

B-lymphocyte antigen CD19

ARID2

2 more biomarker names

Show less

1

1

1

1

bullous pemphigoid

Outcome Measure

BP230

BP180

1

1

chronic obstructive pulmonary disease

Eligibility Criteria

Trypsin

2

chronic sinusitis

Detailed Description

signal transducer and activator of transcription 6, interleukin-4 induced

Fc fragment of IgE receptor II

D-Mannose

CCL17

2 more biomarker names

Show less

1

1

1

1

chronic sinusitis

Eligibility Criteria

mitogen-activated protein kinase kinase kinase 13

AGXT

1

1

chronic sinusitis

Outcome Measure

periostin

Interleukin-5 (IL-5)

Interleukin-4 (IL-4)

Interleukin-13 (IL-13)

immunoglobulin heavy constant epsilon

ECP

CCL26

CCL17

6 more biomarker names

Show less

1

1

1

1

1

1

1

1

circumscribed scleroderma

Outcome Measure

periostin

Interleukin-5 (IL-5)

Interleukin-4 (IL-4)

Interleukin-13 (IL-13)

dipeptidyl-peptidase 4

3 more biomarker names

Show less

1

1

1

1

1

congenital ichthyosiform erythroderma

Detailed Description

Interleukin-4 (IL-4)

Interleukin-23 (IL-23)

Interleukin-13 (IL-13)

Interleukin-12B (IL-12p40)

Interleukin-12A (IL-12p35)

interleukin 37

4 more biomarker names

Show less

1

1

1

1

1

1

congenital ichthyosiform erythroderma

Eligibility Criteria

serine peptidase inhibitor, Kazal type 5

1

COVID-19 respiratory infection

Official Title

Interleukin-13 (IL-13)

1

COVID-19 respiratory infection

Outcome Measure

immunoglobulin heavy constant epsilon

Ferritin

C-reactive protein (CRP)

1 more biomarker names

Show less

1

1

1

eczema

Arm Group Description

9-cis-Retinoic acid

1

eczema

Detailed Description

immunoglobulin heavy constant epsilon

CCL17

1

1

eczema

Official Title

Interleukin-4 (IL-4)

Interleukin-13 (IL-13)

9-cis-Retinoic acid

1 more biomarker names

Show less

1

1

1

eczema

Outcome Measure

thymic stromal lymphopoietin

tachykinin, precursor 1

Substance P

Interleukin-4 (IL-4)

immunoglobulin heavy constant epsilon

IL31

Eotaxin (CCL11)

eosinophil peroxidase

CRLF2

CCL17

8 more biomarker names

Show less

1

1

1

1

1

1

1

1

1

1

eosinophilic oesophagitis

Eligibility Criteria

immunoglobulin heavy constant epsilon

Allergic rhinitis

1

1

eosinophilic oesophagitis

Outcome Measure

nestin

2

food hypersensitivity

Eligibility Criteria

immunoglobulin heavy constant epsilon

1

food hypersensitivity

Outcome Measure

immunoglobulin heavy constant epsilon

1

Grass pollen hypersensitivity

Brief Summary

immunoglobulin heavy constant epsilon

1

Grass pollen hypersensitivity

Eligibility Criteria

immunoglobulin heavy constant epsilon

1

hypersensitivity

Outcome Measure

immunoglobulin heavy constant epsilon

1

keloids

Detailed Description

immunoglobulin heavy constant epsilon

C-reactive protein (CRP)

1

1

milk hypersensitivity

Eligibility Criteria

immunoglobulin heavy constant epsilon

1

mycoses

Eligibility Criteria

mucin 5AC, oligomeric mucus/gel-forming

1

mycoses

Outcome Measure

immunoglobulin heavy constant epsilon

1

nasal polyps

Outcome Measure

PGD2

Leukotriene E4

immunoglobulin heavy constant epsilon

Human Microbiome

CCL17

cathelicidin

4 more biomarker names

Show less

1

1

2

1

1

1

nasal polyps

Brief Title

Human Microbiome

1

nasal polyps

Arm Group Description

Human Microbiome

1

nasal polyps

Detailed Description

defensin beta 4A

defensin beta 132

defensin beta 103B

defensin beta 103A

cathelicidin

3 more biomarker names

Show less

1

1

1

1

1

nasal polyps

Eligibility Criteria

phosphatidylinositol-4-phosphate 3-kinase catalytic subunit type 2 alpha

mucin 5AC, oligomeric mucus/gel-forming

Creatine

1 more biomarker names

Show less

1

1

1

nasal polyps

Official Title

Interleukin-4 (IL-4)

Interleukin-13 (IL-13)

Human Microbiome

1 more biomarker names

Show less

1

1

1

nasal polyps

Brief Summary

TLX1 neighbor

Human Microbiome

cathelicidin

1 more biomarker names

Show less

1

1

1

non-small cell lung cancer

Arm Group Description

PD-L1/CD274

1

non-small cell lung cancer

Arm Group Label

PD-L1/CD274

1

non-small cell lung cancer

Eligibility Criteria

T-cell surface antigen CD4

1

non-small cell lung cancer

Official Title

PD-L1/CD274

1

peanut hypersensitivity

Brief Summary

immunoglobulin heavy constant epsilon

AGXT

1

1

peanut hypersensitivity

Eligibility Criteria

immunoglobulin heavy constant epsilon

1

peanut hypersensitivity

Outcome Measure

immunoglobulin heavy constant epsilon

2

prostate cancer

Detailed Description

PSA

1

prostate cancer

Eligibility Criteria

Alkaline phosphatase (ALPL)

1

prostate cancer

Outcome Measure

T-cell surface antigen CD4

T-Cell differentiation antigen CD8

PSA

Nuclear protein Ki67

mannose receptor, C type 1

Deoxyuridine triphosphate

Annexin A5

5 more biomarker names

Show less

1

1

1

1

1

1

1

rhinosinusitis

Outcome Measure

Twist-related protein 1 (TWIST)

PGD2

Leukotriene E4

immunoglobulin heavy constant epsilon

Human Microbiome

CCL17

cathelicidin

5 more biomarker names

Show less

1

1

1

2

1

1

1

rhinosinusitis

Brief Title

Human Microbiome

1

rhinosinusitis

Arm Group Description

Human Microbiome

1

rhinosinusitis

Detailed Description

signal transducer and activator of transcription 6, interleukin-4 induced

Fc fragment of IgE receptor II

defensin beta 4A

defensin beta 132

defensin beta 103B

defensin beta 103A

D-Mannose

CCL17

cathelicidin

7 more biomarker names

Show less

1

1

1

1

1

1

1

1

1

rhinosinusitis

Eligibility Criteria

phosphatidylinositol-4-phosphate 3-kinase catalytic subunit type 2 alpha

mucin 5AC, oligomeric mucus/gel-forming

mitogen-activated protein kinase kinase kinase 13

Creatine

AGXT

3 more biomarker names

Show less

1

1

1

1

1

rhinosinusitis

Official Title

Interleukin-4 (IL-4)

Interleukin-13 (IL-13)

Human Microbiome

1 more biomarker names

Show less

1

1

1

rhinosinusitis

Brief Summary

Twist-related protein 1 (TWIST)

TLX1 neighbor

Human Microbiome

cathelicidin

2 more biomarker names

Show less

1

1

1

1

seasonal allergic rhinitis

Brief Summary

immunoglobulin heavy constant epsilon

1

seasonal allergic rhinitis

Eligibility Criteria

immunoglobulin heavy constant epsilon

2

sinusitis

Brief Summary

Twist-related protein 1 (TWIST)

1

sinusitis

Outcome Measure

Twist-related protein 1 (TWIST)

1

urticaria

Eligibility Criteria

FSH

1

Show all rows

Biomarker

Drug Name Biomarker Name Biomarker Function
Dupilumab - Regeneron/Sanofi 9-cis-Retinoic acid Arm Group Description, Official Title
AGXT Brief Summary, Eligibility Criteria
Alkaline phosphatase (ALPL) Eligibility Criteria
Allergic rhinitis Eligibility Criteria
Annexin A5 Outcome Measure
ARID2 Eligibility Criteria
B-lymphocyte antigen CD19 Eligibility Criteria
BCAR1, Cas family scaffolding protein Outcome Measure
BP180 Brief Summary, Outcome Measure
BP230 Brief Summary, Outcome Measure
C-C motif chemokine ligand 27 Outcome Measure
C-reactive protein (CRP) Detailed Description, Outcome Measure
cathelicidin Brief Summary, Detailed Description, Outcome Measure
CCL17 Detailed Description, Outcome Measure
CCL26 Outcome Measure
CD3 gamma chain (CD3G) Outcome Measure
CD45 (leukocyte common antigen) Outcome Measure
chymase 1 Outcome Measure
Creatine Eligibility Criteria
CRLF2 Outcome Measure
CUX1 Eligibility Criteria
CYP1A2 Eligibility Criteria
CYP2C19 Eligibility Criteria
CYP2C9 Eligibility Criteria
CYP2D6 Eligibility Criteria
CYP2D7 Eligibility Criteria
CYP3A4 Eligibility Criteria
cytochrome P450 family 2 subfamily B member 6 Arm Group Description, Official Title
D-Mannose Detailed Description
defensin beta 103A Detailed Description
defensin beta 103B Detailed Description
defensin beta 132 Detailed Description
defensin beta 4A Detailed Description
Deoxyuridine triphosphate Outcome Measure
dipeptidyl-peptidase 4 Outcome Measure
ECP Outcome Measure
eosinophil peroxidase Outcome Measure
Eotaxin (CCL11) Outcome Measure
Fc fragment of IgE receptor II Detailed Description
Ferritin Outcome Measure
filamin C, gamma Brief Title
FLG Detailed Description, Outcome Measure
Fluticasone Arm Group Description
FSH Eligibility Criteria
HEAT repeat containing 5B Eligibility Criteria
Human Microbiome Arm Group Description, Brief Summary, Brief Title, Official Title, Outcome Measure
IL31 Outcome Measure
immunoglobulin heavy constant epsilon Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure
Interferon Gamma (IFNg) Eligibility Criteria
Interleukin 1 Beta (IL-1β) Outcome Measure
interleukin 25 Outcome Measure
interleukin 33 Outcome Measure
interleukin 37 Detailed Description
interleukin 4 receptor Brief Summary, Official Title
Interleukin-10 (IL-10) Outcome Measure
Interleukin-12A (IL-12p35) Detailed Description
Interleukin-12B (IL-12p40) Detailed Description
Interleukin-13 (IL-13) Detailed Description, Official Title, Outcome Measure
Interleukin-17 (IL-17) Outcome Measure
Interleukin-23 (IL-23) Detailed Description
Interleukin-3 (IL-3) Outcome Measure
Interleukin-4 (IL-4) Detailed Description, Official Title, Outcome Measure
Interleukin-5 (IL-5) Outcome Measure
Interleukin-6 (IL-6) Outcome Measure
Interleukin-8 (IL-8) Outcome Measure
Leukotriene E4 Outcome Measure
mannose receptor, C type 1 Outcome Measure
Melatonin Outcome Measure
mitogen-activated protein kinase kinase kinase 13 Eligibility Criteria
mucin 5AC, oligomeric mucus/gel-forming Eligibility Criteria, Outcome Measure
nestin Outcome Measure
Nitric Oxide (NO) Detailed Description
Nuclear protein Ki67 Outcome Measure
PD-L1/CD274 Arm Group Description, Arm Group Label, Official Title
periostin Outcome Measure
PGD2 Outcome Measure
phosphatidylinositol-4-phosphate 3-kinase catalytic subunit type 2 alpha Eligibility Criteria
PSA Detailed Description, Outcome Measure
selectin P ligand Outcome Measure
serine peptidase inhibitor, Kazal type 5 Eligibility Criteria
signal transducer and activator of transcription 6, interleukin-4 induced Detailed Description
Substance P Outcome Measure
T-Cell differentiation antigen CD8 Outcome Measure
T-cell receptor CD3-epsilon (CD3e) Outcome Measure
T-cell receptor T3 delta chain (CD3d) Outcome Measure
T-cell surface antigen CD4 Eligibility Criteria, Outcome Measure
tachykinin, precursor 1 Outcome Measure
thymic stromal lymphopoietin Outcome Measure
TLX1 neighbor Brief Summary
transcription factor Dp-1 Arm Group Label
Treacher Collins-Franceschetti syndrome 1 Outcome Measure
Trypsin Eligibility Criteria
Tubulin beta class IVb Arm Group Description, Official Title
Tumor necrosis factor alpha (TNF-alpha) Outcome Measure
Twist-related protein 1 (TWIST) Brief Summary, Outcome Measure
Show all rows
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Trial Landscape

Indication Phase 0 Phase I Phase II Phase III Phase IV
COVID-19 respiratory infection - - 1 - -
Eosinophilic gastroenteritis - 3 1 1 -
Chronic obstructive pulmonary disease - 3 - 2 -
Sinusitis 1 3 9 5 27
Aspergillosis - 3 1 - -
Rhinosinusitis 1 3 7 5 27
Skin eruptions - - - - 1
Adenocarcinoma - - 1 - -
Ulcerative colitis - 3 1 - -
Bullous pemphigoid - 3 - 2 2
Urticaria - 3 2 3 2
Erythema - - - - 1
Non-small cell lung cancer - - 2 - -
Skin disorders 2 9 26 24 134
Breast cancer - - 1 - -
Anosmia - - - - 1
Allergic asthma - 1 1 - 4
Chronic urticaria - 3 - 3 2
Dermatitis 1 9 18 14 126
Pruritus 1 3 2 4 7
Mycoses - 3 1 1 -
Nasal polyps - - 6 5 26
Peanut hypersensitivity - - 3 - 1
Aspirin-induced asthma - - 2 - 3
Depression - - - - 1
Conjunctivitis - - 1 - 2
Eczema - 3 3 - 4
Allergic contact dermatitis - - - - 1
Atopic dermatitis 1 9 15 14 122
Allergic bronchopulmonary aspergillosis - - 1 - -
Circumscribed scleroderma - - 1 - -
Congenital ichthyosiform erythroderma - - - 1 1
Eosinophilia - 3 2 3 7
Prostate cancer - 3 1 - -
Nasal congestion - - - 2 -
Allergic rhinoconjunctivitis - - - - 1
Prurigo nodularis - 3 - 3 7
Asthma - 8 19 11 69
Perennial allergic rhinitis - - - - 1
Genetic skin diseases 1 - - - -
Hypereosinophilic syndrome - - - - 1
Grass pollen hypersensitivity - - 1 - -
Keloids - - 1 - 1
Alopecia areata - - 3 - -
Bronchitis - - - - 1
Eosinophilic oesophagitis - 3 1 2 5
Seasonal allergic rhinitis - - 2 - -
Churg-Strauss syndrome - - - - 1
COVID 2019 infections - - 1 - 2
Allergic rhinitis - - 2 - 2
Food hypersensitivity - 3 4 - 1
HER2 negative breast cancer - - 1 - -
Keratoconjunctivitis - - 1 - -
Milk hypersensitivity - 3 1 - -
Respiration disorders - - - - 2
Chronic sinusitis - - 2 - -
Hypersensitivity 1 12 40 27 192
Eye disorders - - 2 - 2
Show all rows

Development Status

Summary Table

Download Data (CSV)
Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Allergic asthma - Monotherapy No development reported (I) USA, United Kingdom SC / unspecified Regeneron Pharmaceuticals, Sanofi 28 May 2020
Allergic asthma - Combination therapy No development reported (I) USA, United Kingdom SC / unspecified Regeneron Pharmaceuticals, Sanofi 28 May 2020
Aspergillosis In allergic bronchopulmonary aspergillosis - Phase II Bulgaria, France, Germany, Hungary, Japan, Netherlands, Poland, Romania, USA, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 15 Sep 2020
Asthma children aged 6 to 11 years characterised by an eosinophilic phenotype or with oral corticosteroid-dependent asthmano Adjunctive treatment, In children Marketed USA SC / Injection Regeneron Pharmaceuticals, Sanofi 09 Feb 2022
Asthma - Adjunctive treatment, In children Marketed Australia SC / Injection Sanofi 30 Apr 2021
Asthma - Adjunctive treatment, In adolescents, In adults, In the elderly Marketed Australia, Canada SC / Injection Sanofi 30 Apr 2021
Asthma 6 to 11 years Adjunctive treatment, In children Marketed Canada SC / Injection Sanofi-Aventis GmbH 29 Mar 2022
Asthma - In adolescents, In adults, In the elderly Marketed Sweden SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Apr 2021
Asthma children aged 6 to 11 years Adjunctive treatment, In children Marketed Norway SC / Injection Regeneron Pharmaceuticals 03 Apr 2024
Asthma add-on maintenance treatment Patients aged 12 years and older Adjunctive treatment, In adolescents, In adults, In the elderly Marketed Austria, Denmark, Finland, France, Germany, Ireland, Japan, Netherlands, Norway, USA, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Apr 2021
Asthma children aged 6 to 11 years Adjunctive treatment, In children Registered European Union, Iceland, Liechtenstein SC / Injection Regeneron Pharmaceuticals 07 Apr 2022
Asthma add-on maintenance treatment Adjunctive treatment, In adolescents, In adults, In the elderly Registered European Union, Iceland, Liechtenstein SC / Injection Regeneron Pharmaceuticals, Sanofi 07 May 2019
Asthma - In children Phase III Japan SC / Injection Regeneron Pharmaceuticals, Sanofi 21 Jun 2018
Asthma - Adjunctive treatment, In adolescents, In adults Phase III China, India SC / Injection Regeneron Pharmaceuticals, Sanofi 25 Jan 2019
Asthma - Adjunctive treatment, In adolescents, In adults, In the elderly Phase III Russia, South Africa, Turkey SC / Injection Sanofi 01 Jul 2014
Asthma - Adjunctive treatment, In adolescents, In adults, In the elderly Phase III Argentina, Brazil, Chile, Colombia, Israel, Italy, Mexico, Poland, South Korea, Spain, Taiwan, Ukraine SC / Injection Regeneron Pharmaceuticals, Sanofi 09 Aug 2015
Asthma - Adjunctive treatment, In children Phase III Argentina, Brazil, Chile, Colombia, Mexico, Russia, South Africa, Turkey, Ukraine SC / Injection 21 Apr 2017
Asthma 2 to <6 years of age In children, Treatment-experienced Phase III Argentina, Canada, USA SC / Injection Regeneron Pharmaceuticals, Sanofi 03 Jan 2024
Asthma - Adjunctive treatment, In adolescents, In adults, In the elderly Phase II/III Belgium, Hungary, Romania SC / Injection Regeneron Pharmaceuticals, Sanofi 21 Jul 2014
Asthma - Adjunctive treatment Phase II Denmark, Germany, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 27 Jan 2016
Asthma - Combination therapy, Treatment-experienced Phase II Argentina, Chile, Mexico, Poland, Russia, Turkey, USA, Ukraine SC / Injection Regeneron Pharmaceuticals, Sanofi 12 Mar 2018
Asthma - Adjunctive treatment, In adults, In the elderly Phase II New Zealand SC / Injection Regeneron Pharmaceuticals, Sanofi 05 Aug 2014
Asthma - Monotherapy, Treatment-experienced Phase II Chile, Mexico, Poland, Russia, Turkey, Ukraine SC / Injection Regeneron Pharmaceuticals, Sanofi 12 Mar 2018
Atopic dermatitis - In adults, Monotherapy Marketed Austria, Denmark, Finland, Germany, Ireland, Japan, Netherlands, Norway, USA, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 31 Dec 2018
Atopic dermatitis - Adjunctive treatment, In adults, Treatment-experienced Marketed Canada SC / Injection Regeneron Pharmaceuticals, Sanofi 08 Feb 2018
Atopic dermatitis 6-11 years Adjunctive treatment, In children Marketed United Kingdom SC / Injection Sanofi 03 Apr 2024
Atopic dermatitis - Adjunctive treatment Marketed Australia SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Apr 2021
Atopic dermatitis - - Marketed Sweden SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Apr 2021
Atopic dermatitis - In adolescents, In children Marketed Hungary, Poland, United Kingdom SC / Injection Regeneron Pharmaceuticals 30 Apr 2021
Atopic dermatitis moderate to severe atopic dermatitis in 6-11 years Adjunctive treatment, In children Marketed USA SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Apr 2021
Atopic dermatitis uncontrolled moderate-to-severe atopic dermatitis In adolescents, Monotherapy Marketed USA SC / Injection Regeneron Pharmaceuticals 30 Apr 2021
Atopic dermatitis - Adjunctive treatment, In adolescents Marketed Norway SC / Injection Sanofi 03 Apr 2024
Atopic dermatitis moderate-to-severe atopic dermatitis In children Marketed Canada SC / Injection Regeneron Pharmaceuticals, Sanofi 18 Jun 2021
Atopic dermatitis 6 months to 5 years In children, In infants, Treatment-experienced Marketed USA SC / Injection Regeneron Pharmaceuticals 07 Jun 2022
Atopic dermatitis - In adults, Monotherapy, Treatment-experienced Marketed Canada SC / Injection Regeneron Pharmaceuticals, Sanofi 08 Feb 2018
Atopic dermatitis - In children, In infants, Treatment-experienced Marketed Canada SC / Injection Sanofi 20 Apr 2023
Atopic dermatitis - Adjunctive treatment, In adults Marketed Austria, Denmark, Finland, Germany, Ireland, Japan, Netherlands, Norway, USA, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 31 Dec 2018
Atopic dermatitis - In adults Marketed China SC / Injection Regeneron Pharmaceuticals, Sanofi 28 Oct 2022
Atopic dermatitis - Monotherapy Marketed Australia, Hong Kong SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Apr 2021
Atopic dermatitis Moderate-to-severe Atopic Dermatitis In adolescents, Monotherapy, Treatment-experienced Marketed Canada SC / Injection Regeneron Pharmaceuticals, Sanofi 28 Sep 2019
Atopic dermatitis - In adolescents Marketed Japan SC / Injection Regeneron Pharmaceuticals, Sanofi 06 Feb 2023
Atopic dermatitis 6 months–14 years of age In children, In infants Marketed Japan SC / Injection Regeneron Pharmaceuticals, Sanofi 03 Apr 2024
Atopic dermatitis in combination with SAR 440340 Combination therapy Marketed USA SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Apr 2021
Atopic dermatitis - - Marketed Israel, Malaysia SC / Injection Sanofi 30 Apr 2021
Atopic dermatitis 6 months to 5 years In children, In infants, Treatment-experienced Registered European Union SC / Injection Regeneron Pharmaceuticals, Sanofi 21 Mar 2023
Atopic dermatitis severe atopic dermatitis in 6-11 years Adjunctive treatment, In children Registered European Union SC / Injection Regeneron Pharmaceuticals, Sanofi 05 Feb 2021
Atopic dermatitis - Adjunctive treatment, In adults Registered European Union, Iceland, Liechtenstein SC / Injection Regeneron Pharmaceuticals, Sanofi 28 Sep 2017
Atopic dermatitis - Adjunctive treatment, In adolescents Registered European Union, Iceland, Liechtenstein SC / Injection Sanofi 06 Aug 2019
Atopic dermatitis - In adults, Monotherapy Registered European Union, Iceland, Liechtenstein SC / Injection Regeneron Pharmaceuticals, Sanofi 28 Sep 2017
Atopic dermatitis - In adolescents, In adults Phase III Germany, Poland SC / Injection Regeneron Pharmaceuticals, Sanofi 07 Jan 2021
Atopic dermatitis - In adolescents, In children, In infants Phase III Canada, USA SC / Injection Regeneron Pharmaceuticals 15 Oct 2015
Atopic dermatitis - In adolescents, In children, In infants, Treatment-experienced Phase III Japan SC / Injection Regeneron Pharmaceuticals, Sanofi 15 Jan 2021
Atopic dermatitis - Adjunctive treatment Phase III New Zealand, Russia, South Korea, Taiwan SC / Injection Regeneron Pharmaceuticals, Sanofi 13 Oct 2014
Atopic dermatitis - Monotherapy Phase III Singapore, South Korea SC / Injection Regeneron Pharmaceuticals, Sanofi 31 Jul 2015
Atopic dermatitis - In adolescents, In children Phase III Czech Republic, Germany SC / Injection Regeneron Pharmaceuticals 08 Oct 2015
Atopic dermatitis 6 months to 5 years In children, In infants, Treatment-experienced Phase II/III United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Nov 2017
Atopic dermatitis in combination with SAR 440340 Combination therapy Phase II Germany, Netherlands, Spain SC / Injection Regeneron Pharmaceuticals, Sanofi 11 Jun 2019
Atopic dermatitis - In volunteers Discontinued (I) USA IV / unspecified Regeneron Pharmaceuticals, Sanofi 30 Mar 2017
Bullous pemphigoid - - Phase III Unknown SC / Injection Regeneron Pharmaceuticals, Sanofi 31 Oct 2019
Bullous pemphigoid - - Phase II/III France SC / Injection Regeneron Pharmaceuticals 25 Mar 2020
Bullous pemphigoid - - Phase II/III Australia, Germany, Japan, USA SC / Injection Regeneron Pharmaceuticals, Sanofi 28 Oct 2020
Chronic obstructive pulmonary disease moderate-to severe; evidence of type 2 inflammation - Preregistration China, European Union, USA SC / Injection Regeneron Pharmaceuticals, Sanofi 01 Feb 2024
Chronic obstructive pulmonary disease With Moderate to Severe COPD With Type 2 Inflammation moderate-to severe; evidence of type 2 inflammation - Phase III Argentina, Australia, Brazil, Canada, Chile, Colombia, Israel, Japan, Mexico, Peru, Russia, Serbia, South Africa, South Korea, Turkey, Ukraine, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 12 Jun 2020
Chronic urticaria - In adolescents, In adults, In children, In the elderly, Treatment-experienced Marketed Japan SC / Injection Regeneron Pharmaceuticals, Sanofi 16 Feb 2024
Chronic urticaria - In adolescents, In adults, In children, In the elderly, Treatment-experienced Preregistration USA SC / Injection Regeneron Pharmaceuticals, Sanofi 07 Mar 2023
Chronic urticaria - In adolescents, In adults, In children, In the elderly, Treatment-experienced Phase III Argentina, Canada, China, France, Germany, Hungary, Russia, Spain, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 11 Dec 2019
Chronic urticaria - In children Phase III Canada, Japan, USA SC / Injection Sanofi 25 Aug 2022
Chronic urticaria - In adults, In the elderly, Treatment-experienced Phase II Germany SC / Injection 04 Nov 2018
Eczema - Treatment-experienced Phase II Netherlands SC / unspecified Sanofi 01 Aug 2020
Eosinophilic gastroenteritis - In adolescents, In adults, In children, In the elderly Phase II/III Australia, Italy, Poland, USA SC / Injection Regeneron Pharmaceuticals, Sanofi 03 May 2023
Eosinophilic oesophagitis notice of compliance for dupilumab for treatment of patients with 12 years and olderno In adolescents, In adults Marketed Austria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Netherlands, Poland, Spain, Sweden SC / Injection Regeneron Pharmaceuticals, Sanofi 23 Feb 2024
Eosinophilic oesophagitis - In adolescents, In adults, In the elderly Marketed USA SC / Injection Regeneron Pharmaceuticals, Sanofi 28 Oct 2022
Eosinophilic oesophagitis 1-11 years In children, In infants Marketed USA SC / Injection Regeneron Pharmaceuticals 06 Feb 2024
Eosinophilic oesophagitis CHMP issues positive opinion for approval; expanded the marketing authorization In adolescents, In adults Registered European Union SC / Injection Regeneron Pharmaceuticals, Sanofi 30 Jan 2023
Eosinophilic oesophagitis - In adolescents, In adults Phase III Australia, Switzerland, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 24 Sep 2018
Eosinophilic oesophagitis aged 1-11 years In children Phase III Canada SC / Injection Regeneron Pharmaceuticals, Sanofi 01 Sep 2020
Grass pollen hypersensitivity - Adjunctive treatment Discontinued (II) USA SC / unspecified Regeneron Pharmaceuticals, Sanofi 31 Mar 2021
Milk hypersensitivity as an adjunct to milk oral immunotherapy Adjunctive treatment, In adolescents, In adults, In children Phase II USA SC / Injection Regeneron Pharmaceuticals 14 Sep 2021
Peanut hypersensitivity - In adolescents, In children Discontinued (II) USA SC / Injection Aimmune Therapeutics, Sanofi, Regeneron Pharmaceuticals 29 Jul 2022
Peanut hypersensitivity - In adolescents, In children Discontinued (II) Canada SC / Injection Regeneron Pharmaceuticals 29 Jul 2022
Prostate cancer - Neoadjuvant therapy Phase II USA SC / Injection Regeneron Pharmaceuticals 15 Jul 2019
Prurigo nodularis - Treatment-experienced Marketed USA SC / Injection Regeneron Pharmaceuticals, Sanofi 28 Sep 2022
Prurigo nodularis - In adults Marketed Japan, Norway SC / Injection Regeneron Pharmaceuticals, Sanofi 03 Apr 2024
Prurigo nodularis - In adults Registered European Union, Iceland, Liechtenstein SC / Injection Regeneron Pharmaceuticals, Sanofi 14 Dec 2022
Prurigo nodularis - Treatment-resistant Phase III Chile, England, South Korea, Taiwan, United Kingdom SC / Injection Regeneron Pharmaceuticals, Sanofi 16 Nov 2020
Prurigo nodularis - - Phase III Argentina, China, Mexico, Russia SC / Injection Regeneron Pharmaceuticals, Sanofi 12 Dec 2019
Prurigo nodularis - Treatment-experienced Phase III Canada SC / Injection Regeneron Pharmaceuticals, Sanofi 16 Dec 2019
Pruritus - - Phase III Hungary, Italy SC / Injection Sanofi 13 Jan 2022
Pruritus moderate to severe chronic hepatic pruritus - Phase II USA SC / Injection Mayo Clinic, Regeneron Pharmaceuticals 01 Sep 2020
Rhinosinusitis severe chronic rhinosinusitis with nasal polyposis (CRSwNP) chronic rhinosinusitis with nasal polyposis (CRSwNP) Adjunctive treatment Marketed Canada, USA SC / Injection Regeneron Pharmaceuticals, Sanofi 18 Jun 2021
Rhinosinusitis chronic rhinosinusitis with nasal polyposis (CRSwNP) Adjunctive treatment, In adults Marketed Japan, Norway SC / Injection Regeneron Pharmaceuticals, Sanofi 03 Apr 2024
Rhinosinusitis chronic rhinosinusitis with nasal polyposis (CRSwNP) Adjunctive treatment, In adults Registered European Union, Iceland, Liechtenstein SC / Injection Regeneron Pharmaceuticals, Sanofi 29 Oct 2019
Rhinosinusitis chronic rhinosinusitis with nasal polyposis (CRSwNP) Adjunctive treatment Phase III Australia, Israel, Mexico SC / Injection Regeneron Pharmaceuticals, Sanofi 28 Nov 2016
Rhinosinusitis with chronic rhinosinusitis with nasal polyposis (CRSwNP) Adjunctive treatment Phase III China SC / Injection Sanofi 16 May 2023
Rhinosinusitis Allergic Fungal Rhinosinusitis Treatment-experienced Phase III USA SC / Injection Sanofi 23 Oct 2023
Rhinosinusitis - - Phase II USA SC / Injection Regeneron Pharmaceuticals, Sanofi 14 Oct 2013
Rhinosinusitis allergic fungal rhinosinusitis; aged 12 years and older In adolescents, In adults Discontinued (III) USA SC / Injection Regeneron Pharmaceuticals, Sanofi 27 Apr 2023
Rhinosinusitis Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP) In adolescents, In adults Discontinued (II/III) Canada SC / Injection Regeneron Pharmaceuticals, Sanofi 27 Apr 2023
Rhinosinusitis Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP) Treatment-experienced Discontinued (II) Argentina, Belgium, Chile, China, Hungary, Portugal, Russia, South Korea, Spain, Sweden, United Kingdom SC / Injection Sanofi 04 Mar 2024
Ulcerative colitis Moderate to severe UC with an eosinophilic phenotype Treatment-experienced Phase II Japan, South Korea, USA SC / Injection Sanofi 12 Jan 2023
Urticaria cholinergic urticaria Treatment-resistant Phase II Germany SC / Injection Sanofi 10 Dec 2018
Wheezing 2 to <6 years of age for recurrent severe asthmatic wheeze In children, Treatment-experienced Phase III Argentina, Canada, USA SC / Injection Regeneron Pharmaceuticals, Sanofi 03 Jan 2024

Priority Development Status

Type Region Indication
Breakthrough Therapy USA Chronic obstructive pulmonary disease; Atopic dermatitis; Eosinophilic oesophagitis; Atopic dermatitis

Orphan Status

Indication Patient Segment Country Organisation Event Date
Bullous pemphigoid - USA Regeneron Pharmaceuticals 21 Aug 2019
Eosinophilic oesophagitis - USA Regeneron Pharmaceuticals 16 Oct 2017

Related Drugs

Drug Name Highest Phase Owner
Dupilumab biosimilar - Bio-Thera Solutions Preclinical Bio-Thera Solutions

Commercial Information

Involved Organisations

Organisation Involvement Countries
Regeneron Pharmaceuticals Originator USA
sanofi-aventis Originator France
Regeneron Pharmaceuticals Owner USA
Sanofi Owner France
Aimmune Therapeutics Collaborator USA
Sanofi-Aventis GmbH Collaborator Austria
Mayo Clinic Collaborator USA
Charite - Universitatsmedizin Berlin Collaborator Germany
Cincinnati Childrens Hospital Medical Center Collaborator USA
National Institutes of Health Collaborator

Brand Names

Brand Name Organisations Indications Countries
Dupixent Sanofi, Regeneron Pharmaceuticals Chronic obstructive pulmonary disease, Atopic dermatitis, Rhinosinusitis, Prurigo nodularis, Eosinophilic oesophagitis, Asthma, Chronic urticaria USA, Japan, China, Canada, United Kingdom, Australia, European Union

Credit Suisse Market Status

Indication Region Company Phase Expected Launch Year Probability of Success% Patent Expiry Year Expected Generic Entry Last Update
Asthma ex US Regeneron, Sanofi Marketed 2019 100 2032 01 Sep 2032 05 Nov 2023
Asthma US Regeneron, Sanofi Marketed 2018 100 2031 - 05 Nov 2023
Atopic Dermatitis ex US Regeneron, Sanofi Marketed 2017 100 2032 01 Sep 2032 05 Nov 2023
Atopic Dermatitis US Regeneron, Sanofi Marketed 2017 100 2031 01 Apr 2031 05 Nov 2023
chronic spontaneous urticaria ex US Regeneron, Sanofi III 2023 80 2032 01 Sep 2032 05 Nov 2023
chronic spontaneous urticaria US Regeneron, Sanofi III 2023 80 2031 01 Mar 2031 05 Nov 2023
COPD ex US Regeneron, Sanofi III 2025 80 2032 01 Sep 2032 05 Nov 2023
COPD US Regeneron, Sanofi III 2024 80 2031 01 Mar 2031 05 Nov 2023
Eosinophil esophagitis, PN, BP, allergy ex US Regeneron, Sanofi Marketed 2023 100 2032 28 Sep 2032 05 Nov 2023
Eosinophil esophagitis, PN, BP, allergy US Regeneron, Sanofi Marketed 2023 100 2031 - 05 Nov 2023
nasal polyps chronic sinusitus ex US Regeneron, Sanofi Marketed 2020 100 2032 01 Sep 2032 05 Nov 2023
nasal polyps chronic sinusitus US Regeneron, Sanofi Marketed 2019 100 2031 01 Mar 2031 05 Nov 2023

Credit Suisse Financial Forecast

Indication Region 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Last Update
Asthma ex US 150 225 293 357 410 460 506 556 584 600 05 Nov 2023
Asthma US 400 500 625 781 977 1123 1235 1359 1400 1400 05 Nov 2023
Atopic Dermatitis ex US 1336 1924 2540 3099 3563 3991 4310 4655 5000 5000 05 Nov 2023
Atopic Dermatitis US 4208 6090 7803 9050 9648 10008 10308 10618 10600 10600 05 Nov 2023
chronic spontaneous urticaria ex US 0 0 0 100 250 400 540 600 648 750 05 Nov 2023
chronic spontaneous urticaria US 0 0 0 150 300 450 550 650 750 750 05 Nov 2023
COPD ex US 0 0 0 0 50 200 400 600 798 902 05 Nov 2023
COPD US 0 0 0 0 200 400 600 800 864 1000 05 Nov 2023
Eosinophil esophagitis, PN, BP, allergy ex US 0 0 25 100 150 200 300 330 356 385 05 Nov 2023
Eosinophil esophagitis, PN, BP, allergy US 0 0 10 40 30 44 53 63 221 250 05 Nov 2023
nasal polyps chronic sinusitus ex US 50 90 130 160 190 220 260 281 300 300 05 Nov 2023
nasal polyps chronic sinusitus US 50 100 125 145 165 185 204 220 238 250 05 Nov 2023
Total 6194 8929 11551 13982 15933 17681 19266 20732 21759 22187
* All values in US$ millions

Related Safety Reports

Adverse drug reaction Total safety reports Serious reports First reports
Behaviour and behaviour mechanisms 3 3 -
Cardiovascular disorders 28 21 -
Chemically induced disorders 18 12 -
Congenital disorders 1 1 -
Digestive system disorders 19 16 -
Disorders of environmental origin 11 9 -
Drug response related complications 86 84 -
Ear nose and throat disorders 6 3 -
Endocrine disorders 5 4 -
Eye disorders 136 66 -
Female urogenital diseases and pregnancy complications 1 1 -
Genitourinary disorders 7 7 1
Haematological disorders 85 71 -
Immunological disorders 130 79 -
Infections 38 32 -
Male urogenital diseases 1 1 -
Mental disorders 3 2 -
Miscellaneous disease terms 10 9 -
Multisystem disorders 2 1 -
Musculoskeletal disorders 39 22 -
Neurological disorders 48 32 -
Nutritional and metabolic diseases 7 7 -
Pathological conditions signs and symptoms 218 111 -
Pigmentation 7 2 -
Psychiatric disorders 1 - -
Respiratory tract disorders 23 19 -
Sclerosis 2 1 -
Signs symptoms and ill defined conditions 33 18 -
Skin and connective tissue diseases 244 110 1
Stomatognathic disorders 8 7 -
Tissue disorders 9 8 1
Tumours 19 19 -
Show all rows

Scientific Summary

  • Adverse Events Frequent: Infections
    Occasional: Bronchitis; Conjunctivitis; Dizziness; Epistaxis; Headache; Injection site reactions; Nasopharyngitis; Nausea; Pharyngeal disorders; Respiratory tract infections; Skin infections

Adverse Events

Asthma

Updated result from the phase III LIBERTY ASTHMA VENTURE trial showed DPL safety during TRAVERSE was consistent with the known safety profile [193] . In the phase III LIBERTY ASTHMA VENTURE trial in 210 patients with severe steroid-dependent asthma, dupilumab was found to be safe and well tolerated consistent with previous studies. Injection site reactions were experienced by 9% and 4% of patients in the dupilumab and placebo arm, respectively. Mild and transient reversible increase in eosinophil counts was experienced by 14% of patients in the dupilumab arm compared with 1% of patients in placebo arm. The overall rates of adverse events, including infections, conjunctivitis, and herpes were comparable between the dupilumab and placebo groups. Updated results from the trial in patients administered with dupilumab 300mg q2w showed that, at the end of 24 weeks, the most frequently reported adverse events were eosinophil count increase (6.8% versus 0%), eosinophilia (6.8% versus 0.9%), bronchitis (6.8% versus 5.6%), and sinusitis (6.8% versus 3.7%). Conjunctivitis AEs were similar between treatment groups (1.0% versus 0.9%) [204] [203] [201] [202] .

Updated results from phase III EXCURSION trial showed that dupilumab was well tolerated, with an acceptable long-term safety profile for up to 2 years in children with asthma. Of the 365 patients rolled over from phase III VOYAGE trial, 85 (68.0%; placebo/dupilumab) and 147 (61.3%; dupilumab/ dupilumab) of all patients in the trial experienced treatment emergent adverse events (TEAEs), with 3 patients (1.3%) in the dupilumab/dupilumab group leading to treatment discontinuation [149] . In a phase III LIBERTY ASTHMA EXCURSION trial the overall rates of adverse events (AEs) were 61-68%. The most common AEs (≥5%) were nasopharyngitis (9-10%), pharyngitis (6-10%), upper respiratory tract infection (4-8%), influenza (5-6%), eosinophilia (3-6%), allergic rhinitis (3-7%), diarrhoea (4-6%) and injection site reactions (3-7%) [150] [147] [146] .

In the phase III LIBERTY ASTHMA QUEST trial, conducted in patients with persistent asthma, dupilumab was generally well tolerated. The most frequent AE in the DPL 200/300 mg groups vs placebo groups was injection-site reaction (15%/18% vs 5%/10%, respectively) [178] . The overall rates of adverse events, deaths, infections, conjunctivitis, herpes and discontinuations observed with dupilumab, were comparable with the placebo group. Injection site reactions were more common in dupilumab group, observed in 17% patients as compared to 8% patients receiving placebo. Back pain was observed in 4% patients in both the groups and eosinophilia was observed in 4% dupilumab treated group, versus 1% in placebo-treated group. The double-blind, placebo-controlled trial randomised 1902 patients, 2:1, to receive either 200mg or 300 mg dupilumab, every other week or placebo. The most common adverse event observed with higher frequency in dupilumab vs placebo, was injection-site reactions (15%/18% versus 5%/10%). The updated adverse events results showed that the dupilumab subgroups showed lower AERs compared to placebo [184] [175] [381] [173] [171] [171]

In the phase III LIBERTY ASTHMA TRAVERSE trial in patients with moderate-to-severe asthma, dupilumab 300mg demonstrated an acceptable safety profile and was well tolerated over a period of up to 3 years (431.7 patient-years) of cumulative exposure. Overall safety was consistent with the known dupilumab safety profile. A total of 393 patients enrolled in the TRAVERSE continuation study and received treatment with dupilumab (safety population). Of these, 374 (95.2%) completed the full 96-week study treatment. The proportion of patients reporting TEAEs was similar to that observed in shorter-duration studies. The most frequently reported TEAEs (>10% of patients) by System Organ Class (SOC) were infections and infestations (33.1%), respiratory, thoracic, and mediastinal disorders (18.3%), and musculoskeletal and connective tissues disorders (10.7%). Of these, the most common PTs (>5% of patients) were asthma (13.7%), nasopharyngitis (8.4%), and COVID-19 infection (6.4%). Treatment was well tolerated, with 5 patients (1.3%) discontinuing treatment due to TEAEs [197] . Results from the phase III LIBERTY ASTHMA TRAVERSE extension trial demonstrated that proportion of patients with adverse events (AEs) was similar to that seen in prior pivotal trials of dupixent in asthma. Over the 96-week treatment period, overall AE rates were 76-88% and the most common AEs were nasopharyngitis (18-26%) and injection-site erythema (2-23%). Overall serious AEs were experienced by 9-13% of patients. The trial was conducted in 2282 patients with moderate-to-severe asthma who had previously participated in a controlled dupixent clinical trial, including the pivotal phase IIb DRI (24 weeks) and phase III QUEST (52 weeks) trials in patients with moderate-to-severe asthma and the phase III VENTURE (24 weeks) trial in patients with severe oral corticosteroid (OCS)-dependent asthma [187] [189] [172] .

Treatment with dupilumab SC was safe and generally well tolerated, compared with placebo, in the phase III LIBERTY ASTHMA VOYAGE trial, in children (n=408), aged six to 11 years. The safety results from the trial were generally consistent with the known safety profile of dupilumab in patients with moderate-to-severe asthma. Over one year, overall rates of adverse events were 83% for dupilumab and 80% for placebo. Adverse events that were most commonly observed with dupilumab versus placebo included injection site reactions (18% for dupilumab and 13% for placebo), viral upper respiratory tract infections (12% for dupilumab and 10% for placebo), and eosinophilia (6% for dupilumab and 1% for placebo). Serious treatment emergent adverse events were reported by 4.8% of patients receiving dupilumab and 4.5% of patients receiving placebo. Study discontinuation due to adverse events was reported by 1.8% of patients treated with dupilumab and 1.5% placebo-treated patients. Median blood eosinophil values decreased to below the baseline value by week 52 in the dupilumab group. The safety results from the trial were generally consistent with the known safety profile of dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma, with the addition of helminth infections that were reported in 2.2% of dupixent patients and 0.7% of placebo patients. The overall rates of adverse events were 83% for dupixent and 80% for placebo. The most common adverse events that were more commonly observed with dupixent compared with placebo were injection site reactions (18% dupixent, 13% placebo), viral upper respiratory tract infections (12% dupixent, 10% placebo) and eosinophilia (6% dupixent, 1% placebo) [153] [155] [156] [157] .

In a phase III trial, dupilumab was well tolerated with an acceptable safety profile generally consistent with the known safety profile of dupilumab. In the safety population (n=484), TEAE were similar with DPL (84.2%) vs PBO (78.2%).Moreover, in the safety population, proportion of participants experiencing a TEAE was similar in placebo and dupilumab groups [144] [143] .

In a randomised, double-blind, placebo-controlled phase IIb trial in 776 patients with moderate to severe, uncontrolled asthma on inhaled corticosteroid/long-acting β-2 agonist combination therapy, the most common adverse event was injection site reaction, occurring in 13% to 25% of patients in the four dupilumab treatment arms, vs 12% for placebo. Other commonly reported adverse events included upper respiratory tract infection (10% to 13% for the dupilumab arms vs 13% for placebo), headache (5% to 10% for dupilumab vs 8% for placebo), nasopharyngitis (3% to 10% for dupilumab vs 6% for placebo), bronchitis (5% to 8% for dupilumab vs 8% for placebo) and infections (42% to 45% for dupilumab vs 46% for placebo). Serious adverse events occurred in 3% to 7% of patients on dupilumab vs 5% on placebo [215] [216] [217] .

In patients with moderate-to-severe asthma, the incidence of treatment-emergent adverse events were similar for those who received placebo (76.9%) and dupilumab (80.8%). In the phase II trial, the most common adverse events were for placebo and dupilumab were injection site reaction (9.6% and 28.8%), nasopharyngitis (3.8% and 13.5%), upper respiratory tract infection (17.3% and 13.5%), headache (5.8% and 11.5%) and nausea (1.9% and 7.7%) [249] [250] .

Results from the the phase II proof-of-concept trial in patients with asthma showed incidence of adverse events in 61.6%, 66.2%, 56.8%, and 64.9% of patients in the SAR 440340, SAR 440340 and dupilumab, dupilumab monotherapy and placebo arms, respectively. However, the occurence of serious AEs and AEs leading to treatment discontinuations were low. The trial enrolled 296 patients [210] [211] .

Atopic dermatitis:

Integrated analysis from LIBERTY AD clinical trial programme consisting of SOLO 1, SOLO 2, CHRONOS, SOLO-CONTINUE and CAFÉ phase III trials demonstrated that, injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips, were the most common adverse events associated with dupilumab, that occurred at higher rate than placebo [37] .

One year treatment each with dupilumab 300mg/week plus topical corticosteroids (TCS), dupilumab 300mg/two weeks plus TCS, and placebo plus TCS demonstrated adverse events with comparable overall rate (83%, 88%, and 84%, respectively) in patients with inadequately controlled moderate-to-severe atopic dermatitis in the phase III LIBERTY AD CHRONOS trial. The rate of serious adverse events was also comparable between these groups in that order (3%, 4% and 5%, respectively). The placebo plus TCS group had numerically higher serious and/or severe infections (1% in both dupilumab groups and 2% in placebo group). Adverse events that occurred at a higher rate with dupilumab group were injection site reactions (19% (qw) and 15% (q2w) dupilumab; 8% placebo) and conjunctivitis (19% (qw) and 13% (q2w) dupilumab; 8% placebo). History of allergic conjunctivitis was reported at study entry in 8% of patients on placebo, and 19% (qw) and 14% (q2w) of patients on dupilumab. The randomised, double-blind, placebo-controlled trial enrolled 740 patients, who had failed or were intolerant to topical steroids with or without topical calcineurin inhibitors. Patients were randomized in a 3:1:3 fashion into three treatment groups in combination with TCS: first with 319 patients receiving subcutaneous dupilumab 300mg once per week, second with 106 patients receiving subcutaneous dupilumab 300mg every two weeks and third with 315 patients receiving placebo. The 52 week treatment was completed by 85%, 86% and 67% of patients in the dupilumab (qw), dupilumab (q2w) and placebo groups, respectively [82] [83] [86] .

Results from the phase III CAFE study demonstrated that the proportion of patients (n = 325) reporting adverse events was similar in both arms. Conjunctivitis was experienced in 16% and 28% of patients who received dupilumab weekly or every two weeks with TCS, against 11% patients receiving placebo with TCS. Injection site reactions were reported in 11% and 4% among patients who received dupilumab with TCS weekly or every two weeks, respectively, when compared with 5% patients who received placebo with TCS. Skin infections were reported in 4% and 2% among patients who received dupilumab weekly or every two weeks with TCS, respectively, when compared with 8% for patients who received placebo with TCS [73] [74] [72] .

In two phase III SOLO 1 and SOLO 2 (n = 1379) studies, dupilumab was well tolerated, in patients with moderate-to-severe atopic dermatitis. For the 16-week treatment period, the overall rate of adverse events (65-73 percent dupilumab and 65-72 percent placebo) was comparable between the dupilumab groups and the placebo groups. The proportion of patients who completed the treatment period was 88-94 percent for dupilumab and 80.5-82 percent for placebo. The rate of serious adverse events was 1-3 percent for dupilumab and 5-6 percent for placebo. Serious and severe infections were also numerically higher in the placebo groups in both studies (1 percent dupilumab and 1 percent placebo). Adverse events having a higher rate with dupilumab treatment across both studies included injection site reactions (8-19 percent dupilumab; 6 percent placebo) and conjunctivitis (1-5 percent dupilumab; 1 percent placebo); approximately 26 percent of patients in both studies reported a history of allergic conjunctivitis at study entry. No patient discontinued therapy due to injection site reactions and only one patient discontinued therapy due to conjunctivitis [377] [94] [80] .

Phase III:

The initial results from phase III trial in patients with atopic dermatitis (n=180, aged 6 months to 5 years) treated with dupilumab showed generally consistent long term safety profile with the known safety profile in adults and older pediatric patients. 109 (60.6%) patients reported treatment-emergent adverse events (TEAEs). One patient (0.6%) reported a mild case of anemia, and one patient (0.6%) reported a mild case of thrombocytopenia, which were resolving and resolved at the time of interim analysis, respectively. The most common TEAEs were nasopharyngitis (12.8%), upper respiratory tract infection (11.7%), and pyrexia (11.7%). Single patient (0.6%) had a treatment-related severe TEAE (urticaria) that led to study drug discontinuation. Serious TEAEs (anaphylactic reaction and pneumonia mycoplasmal) of severe and moderate intensity observed in two patients respectively. Both serious TEAEs were unrelated to treatment [75] [380] [76]

The updated results of the III open-label trial demonstrated safety data were consistent with the known dupilumab safety prole in patients with AD [93] . The updated results of the III open-label trial demonstrated acceptable safety and effectiveness profiles, which are consistent with the prior 3-year analysis of this study. Over the 4-year open-label extension (OLE) phase, there were low rates of trial withdrawal due to treatment-emergent adverse events (TEAE). Infection rates, including serious infections, were low. The majority of conjunctivitis instances were mild to severe, with the majority resolving or resolved [91] . Updated results from a phase III open-label trial showed acceptable safety profile of dupilumab, 300mg up to 172 week in patients with moderate-to-severe atopic dermatitis. In the trial, 8.3% and 4.2% withdrew due to adverse events and lack of efcacy, respectively. When adverse events rate were adjusted to dupilumab exposure, resulting treatment-emergent adverse events (TEAEs) were lower at 172 week compared with the 52-week AE incident rate in CHRONOS trial (170.2 vs 322.4 nP/100 PY). Serious TEAEs were reported in 9.9% of patients while other 9.5% patients developed severe TEAEs. Greater than one serious TEAE related to dupilumab were reported in 1.2% of patients. 3.6% patients developed TEAEs which required permanent discontinuation of dupilumab. Most common TEAEs were nasopharyngitis (28.5%) and conjunctivitis (19.7%, including conjunctivitis, conjunctivitis allergic/bacterial/viral/atopic kera-toconjunctivitis). Dermatitis atopic (0.8%) and conjunctivitis (0.7%) were the most common severe TEAEs reported among the treated patients. Most of the cases (502; 95%) of conjunctivitis TEAEs were reported as mild/moderate and 87% of conjunctivitis events were recovered/resolved. 63.5% of treatment-emergent conjunctivitis events occurred during the rst year of treatment. Overall, 14 (0.5%) patients permanently discontinued dupilumab due to treatment-emergent conjunctivitis. The data were reported from overall study population (n=2 677). Of the enrolled patients 2,207/1,064/534/253 completed up to 52/100/148/172 weeks, respectively. 215 patients had treatment duration > 172 weeks. In the first-step-analysis from the trial in patients with moderate-to-severe atopic dermatitis, 420.4 adverse events (AEs)/100 patient-years (100PY) were reported with 8.5 serious AEs/100PY. Most commonly reported adverse events included nasopharyngitis (20.5%), upper respiratory tract infection (9.5%) and exacerbation of disease (8.2%). Conjunctivitis due to any cause was reported in 10.7% of patients. At week 52, 393.2 AEs/100PY with 7.6 serious AEs/100PY were reported. Most common adverse events at week 52 were nasopharyngitis (29.2%), headache (10.7%), upper respiratory tract infection (8.3%). The data were presented from 1491 patients [90] [89] [88] .

Updated results of the pivotal, randomised, double-blind, placebo-controlled, phase III LIBERTY AD ADOL trial in adolescent patients with moderate-to-severe atopic dermatitis showed that dupilumab subcutaneous injection was well tolerated and data were consistent with the known dupilumab safety profile observed in adults. Incidence of TEAEs was similar across treatment groups. Food allergy treatment-emergent adverse events were reported for three patients during the study period, including 2 mild events in placebo arm and 1 severe event in dupilumab 200 mg or 300 mg q2w arm [102] . Interim results from 251 adolescent patients with moderate-to-severe atopic dermatitis demonstrated dupilumab safety profile was consistent with that seen in adult patients. The overall rate of adverse events was comparable between the dupilumab groups and placebo (72% for dupilumab every two weeks, 64% for dupilumab every four weeks and 69% for placebo) at 16 weeks. One serious adverse event (AE) and one AE leading to treatment discontinuation with placebo were reported, however none with dupilumab was observed. Adverse events were observed at a higher rate with dupilumab treatment, that included injection site reactions (8.5% for dupilumab every two weeks, 6% for dupilumab every four weeks, when compared with 3.5% for placebo) and conjunctivitis (10% for dupilumab every two weeks, 11% for dupilumab every four weeks, when compared with 5% for placebo). Non-herpetic skin infections were numerically lower in the dupilumab groups (11% for dupilumab every two weeks, 13% for dupilumab every four weeks, when compared with 20% for placebo) [97] [99] [100] [96] .

Updated results of the randomised, double-blind, phase III LIBERTY AD SOLO-CONTINUE trial demonstrated that dupilumab monotherapy was generally well tolerated, with an acceptable safety profile in patients with atopic dermatitis [78] [77] .

In a phase III trial, safety profile of dupilumab was consistent with the known dupilumab safety prole at one year [71] . Earlier results showed that safety profile of dupilumab in the overall population was consistent with the known dupilumab safety prole observed in adults and adolescents [70] [66] . 16 weeks data from a phase III trial for atopic dermatitis showed that overall rates of adverse events were 65% for dupixent every four weeks, 61% for dupixent every two weeks and 72% and 75% for TCS alone. Adverse events that were more commonly observed with dupixent included upper respiratory tract infections (15% for Dupixent every four weeks, 9% for Dupixent every two weeks, and 8% and 12% for TCS alone, respectively), conjunctivitis (7% every four weeks, 9% every two weeks and 3% and 5% for TCS alone, respectively), nasopharyngitis (10% every four weeks, 3% every two weeks and 3% and 10% for TCS alone, respectively) and injection site reactions (10% every four weeks, 14% every two weeks and 7% and 5% for TCS alone, respectively), vomiting (5% for Dupixent every four weeks, 7% for Dupixent every two weeks, and 7% and 7% for TCS alone, respectively) and fever (5% for Dupixent every four weeks, 2% for Dupixent every two weeks, and 7% and 0% for TCS alone, respectively) [21] . Additional prespecified adverse events included skin infections (6% every four weeks, 8% every two weeks and 13% for placebo) and herpes viral infections (2% every four weeks, 3% every two weeks and 5% for placebo) [68] . Earlier, atopic dermatitis patients treated with dupilumab for every four weeks, two weeks and with placebo demonstrated overall rates of adverse events of 65%, 67% and 73%, respectively. Adverse events reported for dupilumab every four weeks, every two weeks and placebo were conjunctivitis (7%, 15% and 4%), nasopharyngitis (13%, 7% and 7%) and injection site reactions (10%, 11% and 6%), respectively. Also patients reported additional prespecified adverse events which included skin infections (6%, 8% and 13%) and herpes viral infections (2%, 3% and 5%), respectively [67] [66] . Updated safety results showed that, safety in the overall population was consistent with the known dupilumab safety profile in adults and adolescents with and without allergic rhinitis [69] .

Results from the phase III Liberty-AD-HAFT trial, with dupilumab in adult and adolescent patients with moderate-to-severe atopic hand and foot dermatitis demonstrated similar safety results to the known safety profile of dupilumab. Overall rates of adverse events (AEs) were 66% for dupilumab and 74% for placebo. AEs more commonly observed with dupilumab (=5%) compared to placebo included nasopharyngitis (16% dupilumab, 11% placebo), upper respiratory tract infection (9% dupilumab, 5% placebo), conjunctivitis (6% dupilumab, 2% placebo), herpes viral infections (6% dupilumab, 3% placebo) and increased blood creatine phosphokinase (6% dupilumab, 0% placebo). Additionally, 3% of patients taking dupilumab used at least one rescue medication compared to 21% of patients on placebo. The open-label trial enrolled 133 patients [61] [60] .

The updated results from phase III LIBERTY AD PRESCHOOL trial demonstrated that overall safety of dupilumab was consistent with already known dupilumab safety profile [62] . Previously, the positive results from phase II/III LIBERTY AD PRESCHOOL trial showed that the treatment with dupilumab was generally well tolerated with an acceptable safety profile. For the 16-week treatment period, overall rates of adverse events (AEs) were 64% for dupixent and 74% for placebo. Most common AEs and AEs of special interest included nasopharyngitis (8% Dupixent, 9% placebo), upper respiratory tract infection (6% Dupixent, 8% placebo), conjunctivitis (5% Dupixent, 0% placebo), herpes viral infections (6% Dupixent, 5% placebo), injection site reactions (2% Dupixent, 3% placebo), molluscum contagiosum (5% Dupixent, 3% placebo), rhinorrhea (5% Dupixent, 1% placebo) and dental carries (5% Dupixent, 0% placebo) [106] [71] [105] [104]

Phase II:

Incidence of nasopharyngitis was balanced across all dupilumab groups compared with placebo group (18.5-23% vs 21%), in a phase IIb trial in patients in moderate-to-severe atopic dermatitis. However, injection site reactions (5-9.5% vs 3%) as well as headaches (12-15% vs 8%) were more common in the dupilumab groups compared with placebo group. Patients in the study were randomised to receive one of five doses of dupilumab 300 mg weekly, 300 mg every other week, 300 mg monthly, 200 mg every other week, 100 mg monthly, or placebo [115] .

In a placebo-controlled phase IIa trial of dupilumab in 109 patients with moderate-to-severe atopic dermatitis, infection related serious adverse events or eczema herpeticum were not seen the dupilumab group. Three patients with skin infections and four patients with atopic dermatitis exacerbations in the placebo group were hospitalised. Most commonly seen treatment related adverse events were nasopharyngitis, headache and conjunctivitis (Regeneron, Form 10-K, February 2015).

Dupilumab 150mg and 300mg given SC once weekly for four weeks was generally well tolerated in patients with atopic dermatitis. These are the results of pooled data from two proof-of-concept trials in 67 patients from the US, Germany, Australia and New Zealand (NCT01385657 and NCT01259323). The most common adverse events in the dupilumab and placebo groups, respectively, were nasopharyngitis (19.6% vs 12.5%) and headache (11.8% vs 6.3%) [123] .

Chronic obstructive pulmonary disease

Phase III

Results from phase III BOREAS trial showed that the safety findings in the dupilumab and placebo groups were similar. TEAEs were balanced between placebo and dupilumab groups [230] . In a phase III BOREAS trial, the safety results were generally consistent with the known safety profile of dupilumab in its approved indications. Overall rates of adverse events (AEs) were 77% for dupilumab and 76% for placebo. AEs more commonly observed with dupilumab compared to placebo included headache (8.1% dupilumab, 6.8% placebo), diarrhea (5.3% Dupixent, 3.6% placebo) and back pain (5.1% dupilumab, 3.4% placebo). AEs more commonly observed with placebo compared to dupilumab included upper respiratory tract infection (9.8% placebo, 7.9% dupilumab), hypertension (6.0% placebo, 3.6% dupilumab ) and COVID-19 (5.7% placebo, 4.1% dupilumab). AEs leading to deaths were balanced between the two arms (1.7% placebo, 1.5% dupilumab) [229] [226] .

Phase III:

Results from the phase III NOTUS trial demonstrated that the safety results were generally consistent with the known safety profile of dupixent. Overall rates of adverse events (AE) were 67% for dupixent and 66% for placebo. AEs more commonly observed with dupixent (=5% and =1% imbalance) compared to placebo included COVID-19 (9.4% dupixent, 8.2% placebo), nasopharyngitis (6.2% dupixent, 5.2% placebo) and headache (7.5% dupixent, 6.5% placebo). AEs more commonly observed with placebo compared to dupixent included COPD (7.8% placebo, 4.9% dupixent). AEs leading to deaths were 2.6% for dupixent and 1.5% for placebo [224] [225] .

Eosinophilic oesophagitis

Phase III:

Updated results from part B and C of the phase III LIBERTY EoE TREET trial demonstrated an acceptable safety profile in part C; the most common (occurring ≥10%) treatment-emergent adverse events in the dupilumab 300 mg weekly (DPL qw)/DPL and placebo/DPL groups were injection-site reactions (13.5% and 10.8%), COVID-19 (9.5% and 10.8%), and nasopharyngitis (4.1% and 10.8%) [291] . Updated pooled data from both cohort A and B of the phase III LIBERTY EoE TREET trial demonstrated that the overall safety was consistent with the known dupilumab safety profile [285] . The updated results from the trial showed that the safety results were generally consistent with the known safety profile of dupixent in its approved indications. Adverse events (=5%) that were more commonly observed with dupixent included injection site reactions, nasopharyngitis and rash [367] . Earlier results from Part B of a phase III trial demonstrated that dupilumab was generally well tolerated in the overall study population. The most common treatment-emergent adverse events for dupilumab /placebo were injection-site reactions (20.0/20.5%), including erythema (10.0/11.5%) [276] . In the part C of phase III trial, administration of dupilumab was safe and generally well tolerated. The most common treatment-emergent adverse events (≥10%) were injection-site reactions (10.0% and 21.6%) and injection-site erythema (10.0% and 13.5%). No rescue medication was initiated by any patient in part C. Earlier, in part B, administration of dupilumab in patients 12 years and older with eosinophilic esophagitis (EoE) showed a consistent safety profile. For the 24-week treatment period, overall rates of adverse events were 84% (67/80) for dupilumab 300 mg weekly and 71% (55/78) for placebo. The adverse events commonly (=5%) observed with administration of dupilumab every week included injection site reactions (38% [30/80] dupilumab, 33% [26/78] placebo), fever (6% [5/80] dupilumab, 1% [1/78] placebo), sinusitis (5% [4/80] dupilumab, 0% [0/78] placebo), COVID-19 (5% [4/80] dupilumab, 0% [0/78] placebo), hypertension (5% [4/80] dupilumab, 1% [1/78] placebo), upper respiratory tract infections (18% dupilumab, 10% placebo), arthralgia (2% dupilumab, 1% placebo) and herpes viral infections (2% dupilumab, 1% placebo). No imbalance was observed in rates of treatment discontinuation due to adverse events between dupilumab (3% [2/80]) and placebo (3% [2/78]) groups prior to week 24. No deaths were reported. Results from the part A of a phase III trial which evaluated the efficacy and safety of weekly dupilumab 300 mg vs placebo in adult and adolescent patients with EoE for 24 weeks of treatment demonstrated that dupilumab was well tolerated. The most common treatment-emergent adverse events for dupilumab vs placebo were injection-site reactions (16.7% vs 10.3%) and nasopharyngitis (11.9% vs 10.3%). Three-part, randomized, placebo-controlled trial enrolled 81 patients and were randomized 1:1 to receive dupilumab (42 patients) or placebo (39 patients) for 24 weeks. Results from the part A of pivotal phase III trial evaluating the safety and efficacy of dupilumab treatment in adult and adolescent patients with eosinophilic oesophagitis showed that trial demonstrated similar safety results to the known safety profile of dupilumab in its approved indications. Overall rates of adverse events were 86% for dupilumab treatment group and 82% for placebo group for the 24-week treatment period. Injection site reactions (n=15 for dupilumab treatment group and n=12 for placebo) and upper respiratory-tract infections (n=11 for dupilumab treatment group and n=6 for placebo) were the most commonly observed adverse events. There was one treatment discontinuation in the dupilumab group, due to arthralgia [368] [282] [277] [279] [283] [284] .

Eosinophilic Esophagitis

Phase III:

Results from the phase III EoE KIDS trial showed that the safety profile of Dupixent over a 16-week period in children aged 1 to 11 years, weighing at least 15 kg, showed similarities to the safety profile observed over 24 weeks in adult and pediatric patients aged 12 years and older with EoE. The most common adverse events (=2%) more frequently observed with Dupixent than placebo were injection rash, headache, site erythema, upper respiratory tract infections (COVID-19 infections), arthralgia (joint pain) and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the Dupixent arm [261] . Previous results from the EoE KIDS trial showed that safety was generally consistent with the known safety profile of dupixent. For the 16-week treatment period, overall rates of adverse events (AEs) were 79% for Dupixent and 91% for placebo. AEs more commonly (=5%) observed with Dupixent compared to placebo included COVID-19 (21% Dupixent, 0% placebo; all cases were mild or moderate and did not lead to study discontinuation), rash (9% Dupixent, 6% placebo), headache (8% Dupixent, 3% placebo), viral gastroenteritis (6% Dupixent, 3% placebo), diarrhea (6% Dupixent, 3% placebo) and nausea (6% Dupixent, 0% placebo). Rates of treatment discontinuation due to AEs prior to week 16 were 0% for Dupixent and 6% for placebo. AEs reported in 20% of patients who remained on higher dose Dupixent in Part B and those who switched from placebo to higher dose Dupixent in Part B, respectively, included: COVID-19 (n=11/37, n=5/18; all cases were mild or moderate and did not lead to study treatment discontinuation), injection site reaction (n=5/37, n=5/18), cough (n=3/37, n=4/18) and headache (n=3/37, n=4/18) [274] [260] [273] [270] [272] [271] .

Phase II

In a phase II trial, treatment with dupilumab in patients (n=47) with eosinophilic oesophagitis demonstrated higher rates of injection site reactions versus placebo. Also no new significant safety concerns were reported. The randomised, double-blind, parallel, placebo-controlled trial is enrolling 47 patients in the trial [268] [292] .

Rhinosinusitis

Phase III

In the pivotal phase III SINUS-52 and SINUS-24 trials, in patients (n=724) with inadequately-controlled chronic rhinosinusitis with nasal polyps, the rates of adverse events were generally similar across dupilumab and placebo, and no new or unexpected side effects related to dupilumab were observed. Dupilumab was safe and generally well tolerated. Common adverse events (in >5% patients) were nasopharyngitis, headache, worsening NP and asthma, epistaxis and injection-site erythema, all occurring with higher frequency in placebo-treated patients. The rates of conjunctivitis were 1.4% dupilumab versus 0.8% placebo in SINUS-24; 2.7% dupilumab every two weeks and 2.0% dupilumab every two/four weeks versus 1.3% placebo in SINUS-52. Overall rates of serious adverse events were lower with dupilumab 4.2% dupilumab versus 14.4% placebo in SINUS-24; 5.4% dupilumab every two weeks and 6.8% dupilumab every two/four weeks versus 10.0% placebo in SINUS-52. Updated results from the SINUS-24 and SINUS 52 trials demonstrated that the treatment-emergent adverse events occurred less frequently in the dupixent group compared to placebo (65% vs. 71% in SINUS-24; 83% vs. 91% in SINUS-52). The rate of serious adverse events was 4% with dupixent vs. 14% with placebo in SINUS-24, and 5% with dupixent versus 10% with placebo, in SINUS-52 trial. Most frequently reported adverse events in the dupixent group compared with placebo. In the SINUS-24 trial (8% vs. 3%) were epistaxis and bronchitis (6% vs. 5%), cough (6% vs. 5%) and injection site reactions (3% vs. 2%) in SINUS-52. Adverse events leading to discontinuation occurred in 4% with dupixent vs. 2% with placebo in SINUS-24 and 4% with dupixent vs. 11% with placebo in SINUS-52 trial. Common (at least 1%) adverse events in the dupixent group were inflammation of the eye and eyelids (conjunctivitis), high count of certain white blood cells (eosinophilia), injection site reactions and injection site swelling. Common adverse events (in >5% patients) were nasopharyngitis, nasal polyps, headache, injection site erythema, asthma, and epistaxis, all occurring more frequently in placebo-treated patients [321] [305] [315] [314] [323] [319] [318] .

Phase II

In a randomised, double-blind, placebo-controlled phase II trial in 60 patients with nasal polyposis and chronic symptoms of sinusitis, the most commonly reported adverse events associated with subcutaneous dupilumab were headache, dizziness, nasopharyngitis, oropharyngeal pain, epistaxis and injection site reactions. Dupilumab was given in combination with intranasal mometasone furoate spray for 16 weeks, in patients who had not responded adequately to intranasal corticosteroids [328] [329] [331] .

Pooled analysis

Treatment with subcutaneously administered dupilumab, was safe and generally well tolerated, in patients (n=724) with severe chronic rhinosinusitis with nasal polyps, in three phase III trials, including the SINUS-24 and SINUS‑52 trials. The most common AEs (in >5% patients) in the intention-to-treat patient population were, nasopharyngitis, headache, worsening nasal polyps and asthma, epistaxis, and injection-site erythema, all occurring with higher frequency in placebo-treated patients [322] [318] [319] .

Adverse events data obtained from phase III SINUS-52 trial indicated that injection-site reaction was the most common adverse event observed at a higher frequency (300mg every 2 weeks (q2w)/q2w– 300mg every 2 weeks (q4w)/placebo: 14.8%/18.9%/13.3%) [319] [320]

Urticaria:

Phase III:

Results from the phase III CUPID (LIBERTY-CUPID) trial showed that, duplimab was found to be safe and well tolerated. For the 24-week treatment period, the occurrence of treatment emergent adverse events were generally similar between the duplimab and placebo groups (50% of duplimab patients and 59% of placebo patients). The most common adverse events were injection site reactions (11.4% duplimab, 13.2% placebo), conjunctivitis 0/1 (1.5%), and serious TEAEs 2 (2.9%)/5 (7.4%) [242] [239] [240] [241] .

Prurigo nodularis

Phase III

In the phase III PRIME2 trial, the safety results were generally consistent with the known safety profile of dupilumab in its approved indications. The occurrences of treatment-emergent adverse events were generally similar between dupilumab and placebo groups (57% dupilumab, 51% placebo). The most common adverse events were conjunctivitis (6.5% dupilumab, 0% placebo), herpes viral infections (6.5% dupilumab, 0% placebo) and skin infections (5% dupilumab, 9% placebo). Additionally, 3% of dupilumab patients and 30% of placebo patients discontinued prior to week 24 [348] [346]

In the phase III PRIME trial, treatment with dupilumab in adults with uncontrolled prurigo nodularis, the safety results of the trial were consistent what was observed in PRIME2, and were also generally consistent with the known safety profile of dupilumab in its approved indications. For the 24-week treatment period, overall rates of treatment-emergent adverse events were 71% for dupilumab and 63% for placebo. Adverse events most commonly observed with dupilumab included nasopharyngitis (5% dupilumab, 4% placebo) and headache (5% dupilumab, 5% placebo). Additionally, 0% of dupilumab patients and 4% of placebo patients discontinued treatment due to adverse events prior to week 24. Consistent with published literature for the atopic dermatitis trials, numerically lower rates of skin infections were seen with dupilumab in this trial (4% dupilumab, 9% placebo) [347] [345] .

Pooled analysis:

Treatment with subcutaneously administered dupilumab in patients (n=311) with prurigo nodularis, in phase III pooled PRIME and PRIME2 trials showed that the most common adverse events (=2%) observed with Dupixent than placebo were nasopharyngitis (5% Dupixent, 2% placebo), conjunctivitis (4% Dupixent, 1% placebo), herpes infection (3% Dupixent, 0% placebo), dizziness (3% Dupixent, 1% placebo), muscle pain (3% Dupixent, 1% placebo), and diarrhea (3% Dupixent, 1% placebo) [338] [345] [346] .

Pharmacodynamics

Summary

Pooled data:

Results from the pivotal phase III LIBERTY AD PEDS, LIBERTY AD PRESCHOOL and LIBERTY AD ADOL trials demonstrated that, treatment with dupilumab reduced levels of type 2 and general inammatory biomarkers, reecting reduction of systemic general and type 2 inammation in patients with moderate-to-severe or severe atopic dermatitis. Reduction in median percentage change from baseline in TARC/CCL17 (pg/mL) and LDH (U/L) was signicantly higher in all dupilumab-treated arms across age groups (P<0.0001 at week 16). Reduction in median change from baseline at week 16 in total IgE (kU/ L) was higher in dupilumab-treated patients than placebo for ages 0.5-5 (difference in median change [95%CI]: -2201.1 [-4497, -902.8], P<0.0001); 6–11 (-2338 [-3391,-1473] and -1888 [-2949, -1038], both P<0.0001) and 12–17 years (-2524 [-3579, -1783.6] and -1996.6 [-3260, -1308], both P<0.0001) [66] [104] [96] .

In the phase III LIBERTY ASTHMA QUEST trial, after one year of treatment with dupilumab, FeNO levels were reduced in patients with baseline FeNO ≥35 ppb. The decline in post-bronchodilator FEV1 slope in dupilumab (−0.013L/year [standard error (SE): 0.017]) was attenuated compared with placebo (−0.089L/year [SE: 0.023]; difference dupilumab vs placebo: 0.075L/year (95% CI: 0.019-0.131). In the intent-to-treat population, the decline in dupilumab was −0.00L/year (SE: 0.01) compared with −0.04L/year (SE: 0.01) in placebo; difference dupilumab vs placebo: 0.04L/year (95% CI: 0.01-0.07). The data support the role of FeNO as a prognostic and predictive biomarker for lung function decline [185] [171] .

Updated data from the phase III LIBERTY ASTHMA VOYAGE study showed that, dupilumab (100/200 mg) reduced annualized exacerbation rate (AER) in the high eosinophils/low FeNO and high eosinophils/high FeNO quadrants of the trial. Values for ppFEV1 were numerically higher in dupilumab, compared to placebo-treated patients at week 12 in all quadrants, leading to improvement in lung function among children. Earlier, the data demonstrated that add-on dupilumab reduced severe asthma exacerbations and improved lung function. In patients aged 6–11 years with uncontrolled, moderate-to-severe asthma, treatment with dupilumab led to suppression of the type 2 biomarkers FeNO, TARC, and IgE. These results suggest broad suppression of multiple downstream type 2 inflammatory processes [161] [158] [157] .

Updated results of the pivotal, randomised, double-blind, placebo-controlled, phase III LIBERTY AD ADOL trial showed that dupilumab subcutaneous injection treatment for 16 weeks resulted in marked reduction in blood levels of total and specific IgE in adolescent patients with moderate-to-severe atopic dermatitis [102] [96] .

Immunogenicity

Summary

Urticaria:

Phase III:

Results from the phase III CUPID (LIBERTY-CUPID) trial showed that, treatment with duplimab potentially targeted IL-4 and IL-13 via IL-4Ra blockade in improving diseases with components of type 2 inflammation in patients with chronic spontaneous urticaria [239] [240] [241] .

Therapeutic Trials

Rhinosinusitis

Pooled analysis

Pooled data from the phase III SINUS-24 and SINUS-52 trials in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) showed that dupilumab reduced the requirement for SCS in patients with CRSwNP and coexisting asthma versus placebo. Asthma control was improved irrespective of asthma exacerbation history, demonstrating concomitant reduction of asthma disease burden and SCS use in those patients. Requirement for on-treatment SCS for any reason was signicantly lower with dupilumab than placebo (20/167 patients [12%] versus 68/170 [40%]), respectively; hazard ratio 0.248, 95% CI 0.150– 0.409 ( P< 0.0001). Nasal polyps and asthma were the most frequent reasons for SCS use (placebo/dupilumab: 27%/3%, 9%/2%, respectively). SCS use was lower with dupilumab than placebo: on-treatment SCS courses (mean [SD] 1.75 [1.21] versus 1.94 [1.67]), total course duration (median days [range] 6.50 [1.0–263.0] versus 12.00 [1.0–74.0]), and cumulative prednisone-equivalent dose (median [range] 181.67 mg [26.7– 4871.5] versus 367.50 mg [10.0–4700.0]), respectively. ACQ-6 and FEV were signicantly improved at week 24 with dupilumab versus placebo, with/without history of asthma exacerbation (all P ≤ 0.0001) [57] . Pooled data from the phase III SINUS-24 and SINUS-52 trials in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) showed that, 300 mg dupilumab signicantly improved Nasal congestion (NC), nasal polyp score (NPS), University of Pennsylvania Smell Identication Test (UPSIT), loss of smell (LoS), Lund-Mackay CT scan score (LMK) and the 22-item Sino-Nasal Outcome Test (SNOT-22) as compared to placebo at 24 and 52 weeks for all the BMI and weight group studied. Pooled data from the phase III SINUS-24 and SINUS-52 trials in chronic rhinosinusitis with nasal polyps (CRSwNP) showed that, dupilumab significantly improved upper and lower airways outcomes in patients with severe CRSwNP and comorbid asthma and improvements were seen irrespective of differences in clinically relevant baseline asthma characteristics. Baseline characteristics were well balanced between the dupilumab and placebo treatment groups across the asthma subgroups (pooled SINUS-24 and SINUS-52 ITT and comorbid asthma populations). Baseline SNOT-22 scores were numerically different between the placebo and dupilumab groups but did not exceed the clinically relevant threshold (minimum clinically important difference of 8.9 points). Dupilumab significantly improved CRSwNP outcomes at week 24 (pooled SINUS-24 and SINUS-52 ITT) and week 52 (SINUS-52 ITT) irrespective of baseline eosinophil level, asthma control, and in patients with lower-than-normal predicted average FEV. Dupilumab significantly improved asthma outcomes in patients with severe CRSwNP and comorbid asthma at week 24 (pooled SINUS-24 and SINUS-52) and week 52 (SINUS-52) irrespective of baseline eosinophil level, asthma control, and in patients with lower-than-normal predicted average FEV [56] . Pooled results of the two phase III SINUS-24 and SINUS-52 trials in intent-to-treat (ITT) population (N = 724) of patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) showed that dupilumab significantly improved symptoms, when compared with placebo, regardless of prior surgery or comorbid asthma. Symptom improvement was observed as early as week 2 and continued until week 52. At baseline, 86.7%, 94.1%, and 64.1% of patients had scores ≥2 for nasal congestion (NC), loss of smell (LoS), and rhinorrhea, respectively, in the pooled ITT population. Of these patients, a significantly greater proportion achieved symptom improvement with dupilumab compared with placebo from week 2 through week 24 and continued improving until week 52. Similar results were observed in patients with prior surgery or comorbid asthma. Among patients who did not achieve scores ≤1 at week 24, a greater proportion of dupilumab-treated versus placebo-treated patients experienced symptom improvement by achieving a score of >1 to ≤2 at week 24. Among the patients in the ITT population with baseline scores ≥2 for all three symptoms, a greater proportion of dupilumab-treated patients had improvement of all three symptoms at weeks 24 and 52 (33.0% and 34.7%, respectively), when compared with 2.2% and 4.4%, respectively, for placebo (all P < 0.0001) [316] . Treatment with dupilumab improved sense of smell, in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24, in patients (n=724) with inadequately-controlled CRSwNP, in the pivotal phase III SINUS-52 and SINUS-24 trials. Dupilumab improved Asthma Control Questionnaire (ACQ-6), total score (least square [LS] mean difference vs placebo: −0.82) at week 24. Treatment with dupilumab also improved individual ACQ-6 item score, woken at night by asthma (−0.76); severity of asthma symptoms after waking in the morning (−0.94); limitation of activities because of asthma (−0.90); frequency of shortness of breath experienced (−0.90); wheezing time (−0.99); and number of puffs of short-acting bronchodilator per day (−0.50) evaluated at week 24. Clinically meaningful improvement of ≥ 0.5 in total ACQ-6 score was achieved in 53.5% of patients treated with dupilumab compared to 23.5% of placebo treated patients. Improvements with dupilumab emerged within the first week in all daily assessed measures: LS mean differences vs placebo emerged by day 3 for loss of smell symptom score (LoSS) (−0.07 [95% CI −0.12, −0.02]), day 2 for nasal congestion (−0.07 [−0.13, −0.01]), day 2 for total symptom scores (−0.14 [−0.27, −0.02]), and day 4 for peak nasal inspiratory flow (PNIF) (5.0 [1.8, 8.1] L/min), all nominal P <0.05. Improvements with dupilumab were sustained and increased through week 52. LS mean differences vs placebo [95% CI] at week 52 in SINUS-52 were, LoSS −1.10 [−1.31, −0.89], NC −0.98 [−1.17, −0.79], TSS −2.85 [−3.35, −2.35], University of Pennsylvania Smell Identification Test (UPSIT) 10.3 [8.5, 12.1], nasal polyp score −2.40 [−2.77, −2.02], SNOT-22 −21.0 [−25.0, −16.9]; all P <0.0001, and PNIF 45.8 [36.5, 55.2] L/min, nominal P < 0.0001. Improvements with dupilumab were observed regardless of asthma, NSAID-ERD, prior surgery, or allergic rhinitis. Earlier results demonstrated that Dupilumab led to a decrease in percentage of anosmic patients to 28% from 77.6% at the baseline (UPSIT score ≤ 18). A reduction to 77.1% was obtained with placebo (least-squares mean differ- ence vs placebo; all nominal p < 0.0001; UPSIT, +10.57; loss of smell, –1.04; decreased smell/taste, –1.97). Dupilumab (nominal P < 0.0001) improved FEV1 (0.26 L), ACQ-6 score (−0.97), and PNIF (52.05 L/min) from baseline to week 24 (least squares mean differences vs PBO) in the assessed patients(n=204). At week 24, urinary leukotriene 4 (ULTE4) decreased from baseline by a median of −57% in SINUS-24, and −76% and −78% in SINUS-52 (DPL 300 mg q2w and q2w–q4w, respectively) trials. Serum total IgE also decreased by a median of −60%. On the co-primary endpoints for both trials at 24 weeks, patients treated with dupilumab added to a standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement in their nasal congestion/obstruction severity compared to a 15% and 19% improvement with nasal spray alone (-1.25 and -1.34 for dupilumab compared to -0.38 and -0.45 for placebo, on a 0-3 scale). Dupilumab-treated patients showed a 27% and 33% reduction in their nasal polyps score compared with a 4% and 7% increase for placebo (-1.71 and -1.89 for Dupixent compared to 0.10 and 0.17 for placebo, on a 0-8 scale that measures bilateral polyps size by endoscopy). Dupilumab also met all secondary endpoints in both trials, including demonstrating a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic rhinosinusitis symptoms. In a pre-specified group of patients with comorbid asthma, dupilumab significantly improved lung function and asthma control (p < 0.0001 for all primary and secondary endpoints in both trials). Updated results from the SINUS-24 and SINUS 52 trials in adults with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) despite previous treatment with surgery and/or systemic corticosteroids demonstrated a 42% and 27% improvement in sinus opacification vs. 4% and 0% with placebo at 24 weeks in SINUS-24 and SINUS-52 (absolute change from baseline of -8.18 and -5.21 for dupixent vs. -0.74 and -0.09 for placebo; p<0.0001 for both). The proportion of patients who required systemic corticosteroids was reduced by 74% with dupixent compared to placebo. The proportion of patients who required sino-nasal surgery was reduced by 83% with Dupixent compared to placebo. In the 59% of patients, who also had asthma, the improvements in lung function were similar to patients in the dupixent asthma program. Treatment with 300mg dupilumab significantly improved the upper and lower airway outcomes (least squares mean difference versus placebo; p < 0.0001 for all), including, forced expiratory volume in 1 second (L) (0.21), 6-item Asthma Control Questionnaire score (−0.82), 22-item Sino-Nasal Outcome Test score (−21.42), nasal peak inspiratory flow (L/minute) (46.15), endoscopic nasal polyp score (−2.04), patient-reported nasal congestion score (−1.04), and sinus Lund-Mackay CT score (−6.43). In SINUS-52 trial, at week 52 a 37% improvement in sinus opacification was achieved with dupixent treatment vs. 2% with placebo (absolute change from baseline of -6.83 for dupixent vs. 0.11 for placebo; nominal p<0.0001) 146% and 108% improvement in ability to identify different smells vs. 19% and 7% with placebo at 24 weeks in SINUS-24 and SINUS-52, respectively (absolute change from baseline of 11.26 and 9.71 for dupixent vs. 0.7 and -0.81 for placebo; p<0.0001 for both). At 24 weeks, a 73% reduction was reported for patients receiving asthma controller medication as a rescue treatment with systemic corticosteroids compared with placebo in SINUS-24 trial, while a 76% reduction was reported in rescue treatment compared with placebo at 52 weeks in SINUS-52 (Kaplan-Meier estimates at 24 weeks were 7% for dupixent vs. 23% for placebo in SINUS-24, HR 0.27 [95% CI: 0.13 to 0.55], nominal p=0.0003; and Kaplan-Meier estimates at 52 weeks were 13% for dupixent vs. 44% for placebo in SINUS-52, HR 0.24 [0.16 to 0.36]; nominal p<0.0001). In both trials, dupixent-treated patients reported an improvement of 52% and 45% improvement in loss of smell compared to a 12% and 10% improvement with placebo (mean change from baseline of -8.18 and -5.21 for dupixent compared to -0.74 and -0.09 for placebo). Baseline characteristics were similar across the dupilumab and placebo groups within each comorbidity. Significant improvements in FEV1 were observed with dupilumab (vs placebo) among patients with asthma (p < 0.0001) and clinical features of COPD (p = 0.0007) at week 16 and were sustained through week 24. There was also a significant improvement in FEV1/FVC ratio, during the trial. Dupixent-treated patients reported an improvement in sense of smell as early as four weeks based on a separate daily assessment 60% and 51% improvement in health-related quality of life vs. 18% and 18% with placebo at 24 weeks in SINUS-24 and SINUS-52, respectively (absolute change from baseline of -30.43 and -27.77 for dupixent vs.-9.31 and -10.4 for placebo; p < 0.0001 for both). At 52 weeks in SINUS-52, there was a 58% improvement in health-related quality of life with dupixent vs. 14% with placebo (absolute change from baseline of -29.84 for dupixent vs. -8.88; p<0.0001) 0.21L improvement in lung function vs. placebo at 24 weeks in SINUS-24 in the subset of patients with asthma at baseline (absolute change from baseline of 0.15L for dupixent vs. -0.06L for placebo; nominal p=0.0004) and 0.21L improvement in lung function vs placebo at 24 weeks in SINUS-52 (absolute change from baseline of 0.17L for dupixent vs. -0.015L for placebo; nominal p<0.0001 [58] [317] [312] [313] [321] [305] [315] [379] [379] [314] [323] [310] [319] [318] .

In the phase III SINUS-24 trial, treatment groups had similar baseline characteristics. Baseline sinus opacification was almost complete, Lund–Mackay (LMK) CT total scores were 9.82 (left), 9.73 (right) in the placebo group, and 9.33 (left), 9.22 (right) in the dupilumab group. At week 24, opacification was significantly improved in dupilumab versus placebo-treated patients (LS mean reductions in LMK-CT score 2 3.56 [left], 2 3.92 [right]; both p< 0.001) and in all individual sinuses (LMK-CT score reductions from 2 0.36 [left maxillary sinus] to 2 0.82 [right osteomeatal complex]; all p< 0.0001). Daily INCS + placebo had no meaningful effect on LMK-CT scores. In dupilumab- treated patients, opacification worsened after 24 weeks off treatment but LMK-CT scores remained lower than in placebo-treated patients. The trial is conducted in 276 patients with bilateral nasal polyps treated with intranasal corticosteroids [326] [318] .

In the phase III SINUS-52 study responder analyses in patients with chronic rhinosinusitis with nasal polyps showed that by week 16, more dupilumab than pbo patients achieved clinically relevant response (onset), with the response maintained at week 52 in >82% of dupilumab patients. 303 patients (dupilumab, n=150; pbo, n=153) were included. The percent of patients with response at ≥1 assessment by W16 (dupilumab vs pbo) were: NPS 75.3% vs 39.2%; LoS 60.6% vs 15.7%; SNOT-22 83.3% vs 66%, respectively. Among dupilumab-treated patients who responded by W16, >82% for NPS, >87% for LoS, and >86% for SNOT-22 maintained response at W52. Over the 52-week study period, 47% of dupilumab pts vs 3% of pbo patients responded in ≥5 of 6 NPS assessments, 47% vs 4% responded in ≥11 of 13 LoS 28-day averages, and 62% vs 22% responded in ≥5 of 6 SNOT-22 assessments, respectively [325] . The phase III SINUS-52 study responder analyses showed that dupilumab treatment led to significant improvements in the objective and subjective endpoints, vs placebo, in patients with severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). At weeks 24 and 52, a greater proportion of patients achieved more than 1-point improvement in the nasal polyp score (NPS) or any of the patient-reported symptoms of nasal congestion (NC), loss of smell (LoS), anterior rhinorrhea, and posterior rhinorrhea scores with dupilumab (n=104/132, 78.8%; n=104/132, 78.8%) versus placebo (n=51/137, 37.2%; n=42/137, 30.7%), respectively (both 0.0001). Also, at weeks 24 and 52, a greater proportion of patients achieved the more stringent responder definition of more than 1-point improvement in NPS and any of NC/LoS/anterior/posterior rhinorrhea scores with dupilumab (n=62/ 132, 47.0%; n=86/132, 65.2%) versus placebo (n=8/137, 5.8%; n=13/ 137, 9.5%), respectively (both 0.0001). The results were obtained from CRSwNP patients in the trial randomized to receive dupilumab 300 mg or placebo, every 2 weeks [324] [319] .

Phase II

A randomised, double-blind, placebo-controlled phase II trial of subcutaneous dupilumab in 60 patients with nasal polyposis and chronic symptoms of sinusitis, met all endpoints at 16 weeks. Dupilumab was given in combination with intranasal mometasone furoate spray for 16 weeks, in patients who had not responded adequately to intranasal corticosteroids. Patients who received dupilumab showed significant improvements in Nasal Polyp Score, as measured by endoscopy (primary endpoint). Dupilumab significantly improved the sense of smell and reduced anosmia. Those who received dupilumab also showed significant improvements in all secondary endpoints; objective measures of sinusitis, nasal air flow and patient-reported symptoms (sense of smell, runny nose, postnasal drip, nasal congestion and sleep disruption). Patients with co-morbid asthma who received dupilumab experienced significant improvements in asthma control. Significant differences were also observed in ACQ-5, VAS and SNOT-22 with least squares mean change difference of -1.09, -3.14, -19.14, respectively (p < 0.001). Predicted FEV1 percent and FEV1 in litres were also improved as compared to placebo in exploratory analysis (LS mean change difference 7.2% and 0.2L; p =0.040 and p = 0.074) [330] [328] [329] [331] .

Pooled analysis

Treatment with subcutaneously administered dupilumab, showed improvement in endoscopic, clinical, radiologic and patient-reported outcomes, in patients (n=724) with severe chronic rhinosinusitis with nasal polyps, with or without non-steroidal anti-inflammatory drug-exacerbated respiratory disease, in the three phase III trials, including the SINUS-24 and SINUS‑52 trials. Collectively, dupilumab improved nasal polyp score (NPS), nasal congestion (NC), disease severity (VAS), CT Lund–Mackay (CT-LMK) sinus opacification score, UPSIT smell test, total symptom score (TSS), daily loss of smell, SNOT-22 and reduced the proportion of patients requiring SCS and/or surgery by 79.4/73.8% in patients, respectively (all nominal P < 0.0001 versus placebo) [322] [318] [319] .

Updated results from the phase III EoE KIDS trial in eosinophilic esophagitis showed that in Gene Set Enrichment Analysis at week 16, overall gene signatures were normalized with higher-exposure dupilumab but relatively unchanged with placebo. Dupilumab signicantly suppressed both signatures versus placebo with median NES of 22.630 versus +0.180 for EDP and 21.895 versus +0.340 for T2INF (both p<0.0001). Changes were maintained with continued dupilumab treatment at week 52. Pearson correlation of log2 fold change in all genes between children and adolescents/adults was 0.978. Dupilumab treatment normalized gene expression in children aged 1 to <12 years with active EoE, strongly correlated with data from adolescents/adults in another EoE dupilumab study [275] . At the 16-week mark, 66% of children who received the higher dose of Dupixent through tiered dosing regimens based on weight (n=32) achieved histological disease remission (defined as ≤6 eosinophils/high power field) (least squares mean difference vs placebo [95% CI], 64.5% [48.19, 80.85], P<0.0001), and PEC <15 eosinophils/hpf (81.1% [68.07, 94.10], P<0.0001), the primary endpoint. In contrast, only 3% of those in the placebo group (n=29) reached remission. The histological remission was sustained at week 52, with 17 of 32 (53%) children treated with dupilumab in parts A and B. Histological remission was also achieved at week 52 in 8 of 1562.9% and 85.7% of dupilumab/dupilumab patients, and 52.9% and 64.7% of placebo/dupilumab patients, achieved PEC <_6 and <15 eosinophils/hpf, respectively in part B. Trial met their primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens. At 16 weeks, 68% of children on higher dose and 58% of patients on lower dose Dupixent achieved the primary endpoint of significant histological disease remission (peak esophageal intraepithelial eosinophil count of =6 eosinophils [eos]/high power field [hpf]) compared to 3% of children on placebo (p<0.0001 for both). Additionally, children receiving higher dose Dupixent experienced the following changes at week 16, 86% reduction in peak esophageal intraepithelial eosinophil count from baseline compared to a 21% increase for placebo (p<0.0001). 0.88 and 0.84 reduction from baseline in disease severity and extent, respectively was observed, as measured at the microscopic level in biopsy specimens compared to a 0.02 and 0.05 increase for placebo (both p<0.0001). 3.5-point reduction in abnormal endoscopic findings from baseline compared to a 0.3-point increase for placebo (p<0.0001). A numerical improvement in the proportion of days children experienced symptoms of EoE from baseline, as reported by caregivers (Pediatric EOE signs/symptoms questionnaire [PESQ-C]), compared to placebo, though not statistically significant. The PESQ-C is a novel endpoint developed by Regeneron and Sanofi used for the first time in this trial, designed to assess symptoms in young children through their caregivers (as signs), as children may have difficulty verbalizing their symptoms themselves. As part of a prespecified exploratory analysis, a 3.09 percentile increase in body weight for age percentile from baseline compared to 0.29 for placebo. At one year, outcomes of secondary endpoints among children who continued on higher dose dupixent and for those switching from placebo to higher dose dupixent was 63% and 53% achieved histological disease remission. 0.97 and 0.89 reduction from baseline in disease severity and 0.89 and 0.86 reduction from baseline in extent, respectively, as measured at the microscopic level in biopsy specimens. 4.8 and 3.6-point reduction in abnormal endoscopic findings from baseline. 0.30 and 0.47-point numerical improvement in caregiver reported pediatric signs and symptoms, as measured by PESQ-C. 5.96 and 5.48 percentile increase in body weight for age percentile from baseline [274] [273] [269] [270] [272] [382] [271] [260] [261] [271]

Eosinophilic oesophagitis

Phase III

Updated results from part B and C of the phase III LIBERTY EoE TREET trial demonstrated persistent improvements in clinical, symptomatic, histologic, endoscopic, and molecular features of EoE up to 52 weeks. At week 52 of Part C, 84.6% of patients in the dupilumab 300mg weekly (DPL qw) DPL/DPL and 67.6% of patients in the placebo/DPL groups achieved peak eos count of ≤6 eos/hpf and mean (SD) absolute change from part B baseline in DSQ score was −30.26 (15.39) for DPL/DPL and −27.25 (11.46) for PBO/DPL patients. At week 52, 100% of patients in the DPL/DPL and 78.4% PBO/DPL groups achieved peak eos count of <15 eos/hpf. Compared to part B baseline, peak eos count, EREFS, HSS grade and stage scores were reduced, and EDP and T2 normalised enrichment scores were suppressed in the DPL/DPL and PBO/DPL groups at week 52 [291] . In updated results from part B, 80 patients received dupilumab and 79 placebo; in part C, 74 continued dupilumab and 37 switched from placebo to dupilumab. Among patients who enrolled in part C from part B, 70% (78/111) had prior STC use. At Week 24, dupilumab improved vs placebo proportion of patients achieving =6 eos/hpf (with prior STC use 69% vs 7%, without 57% vs 0%), <15 eos/hpf (92% vs 11%, 83% vs 0%), and DSQ score (absolute mean [SD] change -27.3 [-15.8] vs -13.6 [12.5], -23.1 [15.6] vs -19.6 [15.0]). patients continuing dupilumab in part C further improved at W52: proportion achieving =6 eos/hpf (with prior STC use 86%, without 81%) and DSQ score (absolute mean [SD] change -31.4 [15.8], -27.7 [14.6]); all patients achieved <15 eos/hpf regardless of prior STC use. patients switching from placebo to dupilumab at W24 improved at W52: pro-portion achieving =6 eos/hpf (with 70%, without 60%), <15 eos/hpf (82%, 70%), and DSQ score (-26.1 [12.6], -29.9 [8.4]). At W52, EREFS and HSS grade/stage scores further improved or were maintained in patients continuing dupilumab and improved in patients switching to dupilumab. Similar results were observed in patients with/without prior inadequate response, in-tolerance, or contraindication to STC [290] . The data of parts A and B of the phase III LIBERTY EoE TREET trial demonstrated that the at week 24, patients in the dupilumab group had fewer mean (SD) dysphagia days vs placebo (part A: 3.1 (3.60) vs 6.3 (4.86), P=0.002; part B: 3.2 (4.14) vs 6.3 (4.66), P=0.0001, respectively). At baseline, mean (SD) days with any action taken to relieve dysphagia was similar in the dupilumab vs placebo group (part A: 7.3 (3.76) vs 8.2 (3.82); part B: 9.5 (3.53) vs 8.7 (3.85), respectively). At week 24, mean (SD) days with any action taken for dysphagia relief was numerically fewer in the dupilumab group vs placebo (part A: 3.6 (3.73) vs 5.7 (4.78); part B: 3.0 (3.84) vs 5.3 (4.69), respectively). At week 24, the number of days with more severe dysphagia, indicated by the need to cough/gag, vomit, or seek medical attention to relieve dysphagia, was numerically fewer in the dupilumab group vs placebo. Least squares mean (standard error) change from baseline at week 24 in DSQ pain score was −10.06 (1.11) for dupilumab vs −4.37 (1.22) for placebo in part A (difference vs placebo: −5.69 [95% CI; −8.67 to 2.72]; P=0.0002), and −9.95 (0.92) for dupilumab vs −6.48 (0.95) for placebo in part B (difference vs placebo: −3.46 [95% CI; −5.90 to −1.03]; P=0.0053) [289] . In updated results from parts A and B of the phase III LIBERTY EoE TREET trial (n=240; 81 patients enrolled in part A and 159 patients in part B), dupilumab improved EoE-Endoscopic Reference Score (EREFS) total score vs placebo, as well as inflammation and remodeling EREFS subscores, over 24 weeks, substantiating previously reported symptomatic and histologic efficacy in LIBERTY-EoE-TREET. Dupilumab treatment also led to improvements in proximal and distal edema, rings, exudates, and furrows, and distal stricture. At week 24, dupilumab demonstrated significantly greater improvement in total EREFS vs placebo (part A: LS mean difference –2.9 [95% CI, –3.91, –1.84], P<0.0001; part B: –3.8 [–4.77, –2.93], nominal P<0.0001). Dupilumab also demonstrated improved EREFS inflammation subscore vs placebo (part A: LS mean difference –2.4 [95% CI, –3.30, –1.54], nominal P<0.0001; part B: –2.9 [–3.62, –2.26], nominal P<0.0001) as well as remodeling subscore vs placebo in part B (–0.9 [–1.31, –0.51], nominal P<0.0001). There were also numeric improvements (–0.4 [–0.81, 0.05], nominal P=0.0868) in remodeling subscore in part A. At week 24, dupilumab treatment led to nominally significant improvements vs placebo in proximal and distal edema, rings, exudates, and furrows, and distal stricture in part B and numeric improvements in all features except stricture in part A [288] . Earlier, results from the trial demonstrated that the at baseline, mean peak eos/hpf (SD) scores were 89.3 (48.3) for part A and 86.8 (44.0) for part B, HSS grade score 1.29 (0.44) and 1.27 (0.39), and HSS stage score 1.34 (0.37) and 1.26 (0.34), respectively. There were significant improvements in histologic response (≤6 eos/hpf) for dupilumab vs placebo in parts A and B (all P<0.0001); dupilumab also significantly increased the proportion of patients reaching ≤1 and <15 eos/hpf in part A (P<0.05 and P<0.0001, respectively) and in part B (all P<0.0001). HSS grade/stage scores were significantly improved with dupilumab vs placebo: LS mean difference -0.76 (95% CI -0.91, -0.61)/-0.74 (-0.88, -0.60) for part A, and -0.68 (-0.79, -0.57)/-0.67 (-0.78, -0.57) for part B (all P<0.0001). Significant improvements were observed for the histologic components BZH, EI, EA, ESL, SEA grade/stage scores (P<0.0001) in both parts, DIS grade score in part A (P<0.05), and DEC grade/stage scores (P<0.05) in part B; the other components showed numeric improvements [287] . In updated results from parts A and B of the phase III LIBERTY EoE TREET trial in EoE patients with type 2 comorbid disease at week 24, dupilumab showed numerical improvements in outcomes related to comorbid disease. Least squares (LS) mean change from baseline in Asthma Control Questionnaire (ACQ) in patients with asthma treated with dupilumab vs placebo was -0.34 (0.171) vs -0.10 (0.245) in part A, and -0.59 (0.111) vs -0.43 (0.114) in part B. LS mean change from baseline in Patient-Oriented Eczema Measure (POEM) in patients with atopic dermatitis treated with dupilumab vs placebo was -1.8 (4.01) vs -0.4 (2.76) in part A, and -3.9 (1.36) vs 1.8 (1.22) in part B. In patients with allergic rhinitis, LS mean change from baseline in TNSS treated with dupilumab vs placebo was -1.7 (0.49) vs -1.1 (0.60) in part A and -1.1 (0.25) vs -0.7 (0.23) in part B, and in Standardized Rhinoconjunctivitis Quality of Life Questionnaire for ages 12+ (RQLQ(S)+12) was -0.44 (0.141) vs -0.43 (0.165) in part A and -0.61 (0.112) vs -0.38 (0.101) in part B [286] . Previous pooled data from both cohort A and B showed statistically significant, clinically meaningful improvements in histologic and endoscopic outcomes and symptoms in adults and adolescents with EoE [285] . Earlier results of weekly dupilumab 300 mg vs placebo in adult and adolescent patients with EoE showed that patients receiving dupixent weekly experienced improvement in the ability to swallow and achieved histological disease remission. Additionally, these patients experienced improved anatomic, cellular, molecular and health-related quality of life measures, with improvements in signs and symptoms of EoE sustained for up to one year. Patients treated with dupixent every two weeks experienced histological disease remission but did not experience improvement in the ability to swallow [367] . Earlier results from part B of a phase III trial demonstrated the substantial improvements in clinical, symptomatic, histologic, and endoscopic aspects of the disease in adults and adolescents with eosinophilic esophagitis (EoE), up to 24 weeks regardless of history of prior STC use for eosinophilic esophagitis (EoE). 55 out of 80 patients (69%) in the dupilumab group, and 56 out of 79 patients (71%) in the placebo group had a history of STC use for EoE. For patients treated with dupilumab vs. placebo, a peak oesophageal intraepithelial eos count of 6/hpf was achieved by 63.6% vs. 5.4% of patients with prior STC use, and 48.0% vs. 8.7% of patients with no prior STC use. The least squares mean change from baseline in the DSQ score for dupilumab vs. placebo was –24.3 vs. –12.6 for those patients with prior STC use and –22.9 vs. –16.1 for those with no prior STC use. Dupilumab improved outcomes vs. placebo for primary and key secondary efficacy endpoints, with comparable results in patients with and without prior STC use [276] . The updated results from the part C of a phase III trial demonstrated that out of 81 patients in part A, 77 of them proceeded to part C to evaluate efficacy endpoints at 52 weeks. It was observed that 55.9% and 60% of patients with dupilumab and placebo, respectively, achieved a peak oesophageal intraepithelial eosinophil (eos) count of ≤6eos/high-power field (hpf). Around 82.4% of patients treated with dupilumab achieved <15eos/hpf, compared to 70% of patients with placebo. The patients experienced mean (SD) absolute of –23.4 (16.15) and –75.9% (36.89) change from the part A baseline, compared to that of 21.7 (17.14) and –65.9% (49.71), respectively in placebo group. It was also seen that the total EREFS was reduced to half from part A BL in both dupilumab and placebo patients at week 52. 69% and 64% reduction in disease symptoms from baseline compared to 32% and 41% for placebo. Disease symptoms were measured by the Dysphagia Symptom Questionnaire (DSQ), where patients receiving Dupixent experienced a 21.9- and 23.8-point clinically meaningful improvement compared to 9.6- and 13.9-point improvement for placebo. Approximately 10 times as many patients achieved histological disease remission (peak esophageal intraepithelial eosinophil count of =6 eos/high power field [hpf]) compared with placebo: 60% and 59% compared with 5% and 6% of patients receiving placebo. Updated results from the part B of the study (n=159) showed that weekly dupilumab vs placebo demonstrated statistically signicant, clinically meaningful improvements in symptoms in adults/adolescents with EoE, with a greater proportion of patients achieving histological remission. Baseline demographics/disease activity were similar for dupilumab/placebo treatment groups demonstrated mean (SD) eosinophils/hpf 89.2(46.7)/84.3(41.2), mean (SD) DSQ scores 38.4(10.7)/36.1(10.6). At week 24, 58.8% of dupilumab vs 6.3% placebo-treated patients achieved histological remission ( p< 0.0001). Least squares mean absolute changes in DSQ score were-23.78(SE 1.86) vs 13.86(1.91) for dupilumab vs placebo (p< 0.0001). Previous updated results from the part B, in patients 12 years and older with eosinophilic esophagitis (EoE), administration of dupilumab demonstrated that the trial met its co-primary endpoints in patients administering dupilumab 300 mg weekly and showed significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. The trial enrolled 80 patients into a dupilumab 300 mg weekly treatment group and 79 patients were enrolled into a placebo group. The co-primary endpoints at 24 weeks assessed patient-reported measures of difficulty swallowing (change from baseline in the Dysphagia Symptom Questionnaire, or DSQ), and esophageal inflammation (proportion of patients achieving peak esophageal intraepithelial eosinophil count of =6 eos/hpf). Patients treated with dupilumab (Dupixent) 300 mg weekly experienced 64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008). Dupilumab patients experienced a 23.78 point improvement on the 0-84 DSQ scale, compared to a 13.86 point improvement for placebo (p<0.0001); baseline DSQ scores were approximately 38 and 36 points, respectively. Nearly 10 times as many dupilumab patients achieved histological disease remission: 59% of patients achieved histological disease remission compared to 6% of placebo patients (p<0.0001). This was measured by the proportion of patients who achieved a peak esophageal intraepithelial eosinophil count of =6 eos/hpf; mean baseline peak levels were 89 and 84 eos/hpf, respectively. Results from the part A of a phase III trial demonstrated that, at baseline, mean Eosinophilic Esophagitis Impact Questionnaire (EoE-IQ) was 2.0/2.4 and mean Eosinophilic Esophagitis Symptom Questionnaire (EoE-SQ- Frequency) was 10.1/11.5 in dupilumab/placebo groups, respectively. At week 24, LS mean change from baseline difference for dupilumab versus placebo was 0.4(95% CI: 0.6, 0.1;nominal 0.008) for EoE-IQ and 1.7 (2.9, 0.5;nominal 0.005) for EoE-SQ-Frequency. At week 24, 40.5% versus 7.7% (nominal 0.001) of dupilumab versus placebo was reported as compared with baseline on the Patient Global Impression of Change (PGIC) which was reported as 26.2% versus 10.3% (nominal 0.074). Results from the part A of a phase III trial which evaluated the efficacy and safety of weekly dupilumab 300 mg vs placebo in adult and adolescent patients with EoE for 24 weeks of treatment demonstrated significant and clinically meaningful improvements in histologic, symptomatic, endoscopic, and molecular aspects of EoE. Baseline characteristics were comparable in both treatment groups. At Week 24, a significantly higher proportion of patients treated with dupilumab vs placebo achieved a peak eos count of = 6 eos/hpf (59.5% vs 5.1%, 0.001) and &lt; 15 eos/hpf (64.3% vs 7.7%, 0.001). Dupilumab-treated patients had a significantly greater percent change from baseline in peak eos count (LS mean difference -68.26% [95% CI -86.90 to -49.62], 0.001); significantly greater change in DSQ score (LS mean difference -12.32 [95% CI -19.11 to -5.54], 0.001); and significantly greater change in total EREFS (LS mean difference -2.9 [95% CI -3.91 to -1.84], 0.001) compared with placebo. Dupilumab, but not placebo, significantly suppressed both the EDP NES and type 2 inflammation NES. Three-part, randomized, placebo-controlled trial enrolled 81 patients and were randomized 1:1 to receive dupilumab (42 patients) or placebo (39 patients) for 24 weeks. Results form the part A of pivotal phase III trial evaluating the safety and efficacy of dupilumab treatment in adult and adolescent patients with eosinophilic oesophagitis showed that the trial met both of its co-primary endpoints, as well as all key secondary endpoints. Dupixent treated patients (300 mg weekly, 24 weeks from baseline)demonstrated significant clinical, histologic and anatomic improvements, including the ability to swallow. Dupixent treated patients showed 69% reduction in disease symptoms compared to 32% for placebo (p = 0.0002). A 21.92 point improvement in disease symptoms, the co-primary endpoint with dupixent was observed as compared to a 9.60 point improvement for placebo, on a 0-84 scale (p=0.0004). Baseline DSQ scores were approximately 34 points. Reduction in their oesophageal eosinophilic count to a normal range was 60% in dupixent treated patients compared to to 5% for placebo treated patients, (p < 0.0001), the co-primary endpoint, measured in the proportion of patients who achieved a peak oesophageal intraepithelial eosinophil count of =6 eos/hpf (a normal range); mean baseline peak levels were 89 eos/hpf. Abnormal endoscopic findings reduced by 39% in dupixent treated patients compared to 0.6% worsening for placebo. This was measured by the EoE Endoscopic Reference Score (EoE-EREFS), where patients experienced a 3.2 point reduction with dupixent compared to a 0.3 point reduction for placebo (p < 0.0001). Updated results from the study showed that treatment with dupilumab exhibited significant improvement on the Dysphagia Symptom Questionnaire (DSQ) as early as 4 weeks and continued to improve through 24 weeks (p < 0.05 and p < 0.001, respectively). The antibody also decreased oesophageal eosinophil count <15 eosinophils/high-power field (eos/hpf) in 64% of patients than 8% for placebo at 24 weeks (p < 0.001). Peak esophageal eosinophil count was reduced by 71% with Dupixent compared to 3% with placebo from baseline (p < 0.001). In patients treated with dupilumab, the grade and stage scores that measure esophageal tissue changes associated with the disease were decreased compared with placebo at 24 weeks (Reduction of 0.761 and 0.753 with dupixent and 0.001 and 0.012 with placebo; p < 0.001 for all values). Moreover, the EoE Histology Scoring System (EoE-HSS) grade and stage scores measure changes in eight cellular and tissue features on four-point scales, respectively post dupilumab treatment. Gene expression analysis showed that the patterns associated with type 2 inflammation and EoE were reduced by 1.97-fold and 2.66-fold, compared with a 0.32-fold and 0.16-fold reduction with placebo, respectively, as measured by the Normalised Enrichment Score (NES) at 24 weeks from baseline. The NES evaluated a panel of genes associated with type 2 inflammation or EoE (p < 0.001 for all values). The changes observed with dupilumab demonstrate a shift in gene expression pattern from one that resembles EoE disease to a pattern that resembles healthy controls [282] [277] [279] [278] [368] [281] [280] [283] [284] .

Phase II

In a phase II trial, treatment with dupilumab in patients (47) with eosinophilic oesophagitis, demonstrated a mean baseline Straumann Dysphagia Instrument (SDI) score of 6.4. Patients receiving 300mg dose weekly reported a significant improvement in the ability to swallow with a 3 point reduction in the SDI score (45% improvement) compared to 1.3 (19% improvement) for patients receiving placebo (p=0.0304), at week 10. The double-blind, placebo-controlled, randomised, parallel study is enrolling 47 patients in the US [268] [292] .

Prurigo nodularis

Phase III:

Results from the phase III PRIME2 trial for prurigo nodularis demonstrated significantly reduced itch and skin lesions compared to placebo in this investigational setting. The trial has met its primary endpoint at week 12 showing that the 44% and 37% of the patients experienced a clinically meaningful reduction in itch from baseline compared to 16% and 22% of placebo patients (p=0.0216). At week 24, nearly three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline: 58% of Dupixent patients compared to 20% of placebo patients (p<0.0001). At 24 weeks, Dupixent patients were nearly three times as likely to achieve clear or almost clear skin: 45% of Dupixent patients compared to 16% of placebo patients (p<0.0001). Dupixent patients experienced significantly greater improvements in measures of health-related quality of life, skin pain and symptoms of anxiety and depression [348] [346] .

In the phase III PRIME trial, treatment with dupilumab in adults with uncontrolled prurigo nodularis, met its primary and key secondary endpoints, showing that dupilumab significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting. Results comparing dupilumab (n = 75) to placebo (n = 76) at week 24 showed that, more than three times as many dupilumab patients experienced a clinically meaningful reduction in itch from baseline, the primary endpoint 60% and 58% of dupilumab patients compared to 18% and 20% of placebo patients (p < 0.0001). More than twice as many dupilumab patients achieved clear or almost clear skin, a key secondary endpoint: 48% and 45% of dupilumab patients compared to 18% and 16% of placebo patients (p = 0.0004). More than three times as many Dupixent patients (39% and 32%) experienced both a clinically meaningful reduction in itch and clear or almost clear skin, compared to 9% and 9% of placebo patients at 24 weeks. Dupilumab patients experienced significantly greater improvements in measures of health-related quality of life, skin pain and symptoms of anxiety and depression [347] [345] .

Results from phase II/III ENGAGE trial demonstrated that the primary endpoints were the proportion of patients achieving peak gastric eosinophil count of <_6 eosinophils per high-power eld (eos/ hpf) at week 24 (Parts A and B) and absolute change in the EoG/EoD Symptom Questionnaire Total Symptom Score from baseline to week 24 (Part B). Secondary endpoints include proportion of patients achieving both peak gastric and duodenal eos of <_6 eos/hpf and <_15 eos/hpf, respectively, at weeks 24 and 52, and incidence of adverse events [258] [257]

Phase II

In patients with persistent, moderate-to-severe eosinophilic asthma, subcutaneous dupilumab produced statistically significant improvements in lung function and other asthma control parameters, such as forced expiratory volume over one second (FEV1). In the phase II study, patients were treated with dupilumab (n = 52) or placebo (n = 52) in combination with inhaled glucocorticosteroids (ICS) and long-acting β-agonist (LAβA) therapy for the initial four weeks. The LAβA was withdrawn at week four and the glucocorticosteroids were tapered to withdrawal between weeks six and nine. Patients were treated for 12 weeks or until they experienced a protocol-defined asthma exacerbation (primary endpoint). A total of three patients (5.8%) who received dupilumab experienced asthma exacerbation, compared with 23 patients (44.2%) who received placebo, resulting in an 87% reduction in the incidence (p < 0.0001) [249] .

In a randomised, double-blind, placebo-controlled phase IIb trial in 776 patients with moderate to severe, uncontrolled asthma on inhaled corticosteroid/long-acting β-2 agonist combination therapy, the three highest doses of dupilumab met the primary endpoint of a significant improvement in FEV1 at 12 weeks in the subgroup of patients with high eosinophil levels (≥300 cells/µL). In this subgroup, the mean percent changes in FEV1 at 12 weeks were 26% for those who received dupilumab 200mg or 300mg Q2W, vs 10% for placebo (p<0.01). In the overall population, the mean percent changes in FEV1 at 12 weeks were 18% for those who received dupilumab 200mg or 300mg Q2W, vs 6% for placebo (p<0.001). Dupilumab treatment resulted in a reduction in the adjusted annualised rate of severe exacerbations compared to placebo (64% to 75% reduction; p<0.05 for high eosinophils group, and p<0.01 for the overall population). Patients continued on their inhaled corticosteroid/long-acting β-2 agonist combination therapy during the trial. On secondary endpoints focused on patients with low blood eosinophil counts (LEos), patients who received either dupilumab 200mg or 300mg Q2W showed a >8% improved in FEV1 at week 12, compared with placebo (p<0.001), both in combination with ICS/LAβA. Additionally, dupilumab plus ICS/LABA showed reductions of 68% and 62%, respectively, in adjusted annualised rate of severe exacerbations in the LEos population (p<0.01 and p<0.05), compared with placebo plus ICS/LABA. Dupilumab was also shown to significantly reduce mean fractional exhaled nitric oxide (FeNO) across both doses tested (200 and 300 mg Q2W) and the three patient populations (overall, LEos and patients with high blood eosinophil counts [HEos]), in a roughly dose-dependent manner [215] [216] [217] .

In a randomised, double-blind, placebo-controlled phase IIb trial in 776 patients with moderate to severe, uncontrolled asthma, 300mg Q2W and 200mg Q2W of dupilumab resulted in sustained suppression of type 2 inflammatory biomarkers versus placebo. In addition, a specific decline in IgE levels were observed in dupilumab treated patients. The least-squares (LS) mean percent changes from baseline to week 24 for 300mg Q2W / 200mg Q2W / placebo, respectively, were: FeNO ( − 29.4%/ − 21.9%/ + 10.9%), serum TARC ( − 26.7%/ − 29.4%/ + 11.0%), plasma eotaxin-3 ( − 26.6%/ − 37.8%/ + 20.0%), and serum total IgE ( − 46.9%/ − 52.2%/ + 11.6%); all p ≤ 0.0001 versus placebo. Further, dupilumab suppressed fractional exhaled nitric oxide (FeNO), TARC and eotaxin-3 with near-maximal decreases by week 2 which were similar and sustained for the Q2W regimens, but smaller for Q4W dosing [378] [214] .

Results from the the phase II proof-of-concept trial in patients with asthma showed that SAR 440340 monotherapy led to a significant reduction in loss of asthma control and improved lung function compared with placebo, with the greatest improvement observed in patients with blood eosinophil levels = 300 cells/microliter. Dupilumab monotherapy demonstrated numerically better outcomes across all endpoints than SAR 440340 monotherapy. However, an increased benefit was not observed with a combination of SAR 440340 and dupilumab compared with dupilumab monotherapy. The trial enrolled 296 patients [210] [211] .

Asthma:

Phase III:

In the phase III LIBERTY ASTHMA VENTURE trial, patients received dupilumab 300 mg or placebo every 2 weeks for 24 weeks. Patients with baseline ppFEV1 <60% had an odds ratio (OR) of Oral corticosteroids (OCS) elimination for dupilumab vs placebo of 6.76 (95% CI: 2.73, 16.77; P<0.0001), while those with baseline median post-BD FEV1 or less had an OR of 6.06 (95% CI: 2.14, 17.17; P<0.001). The mean change in pre-BD ppFEV1 for dupilumab vs placebo was significantly higher in patients not achieving OCS elimination (LS mean difference: 7.36 [95%CI: 2.53, 12.19]; P=0.003), but not for those achieving OCS elimination (6.00; [95% CI: −1.52, 13.53]; P=0.12). However, the overall OCS-elimination-by-treatment interaction was not significant (P=0.83) [209] [208] . Earlier, results showed decreased AER in QUEST (1.67 vs 2.59, respectively) and TRAVERSE (DPL/DPL 0.78 and PBO/DPL 0.56) in the exacerbator group as compared to placebo. DPL preserved low AER (annualized severe exacerbation rate) (0.11 DPL/DPL and 0.17 PBO/DPL) in the non-exacerbator group in TRAVERSE. In the exacerbator group, the mean pp FEV1 change was 10.09 vs 14.84 for DPL/DPL vs PBO/DPL; in the non-exacerbator group, it was 13.28 vs 13.10 [193] .The phase III LIBERTY ASTHMA VENTURE trial in 210 patients with severe, steroid-dependent asthma met its primary and key secondary endpoints. At week 24, mean baseline AM/PM symptom scores reported in the dupilumab and placebo groups were 1.37/1.37 and 1.50/1.52 in the ITT population. In the patients who reduced OCS use 100% by week 24 mean baseline AM/PM symptom scores observed were 1.45/1.49 and 1.50/1.52. Dupilumab group showed improved symptoms till week 16 and maintained that effect till week 24. Dupilumab patients group showed a similar pattern response with a greater magnitude of symptom improvements [205] . The effect of dupilumab on asthma control and health-related quality of life (HRQoL) in 210 patients with oral-corticosteroid (OCS) dependent, severe asthma revealed that dupilumab versus placebo significantly improved asthma control and improved HRQoL as early as week 2 and was for 24 weeks. Mean baseline ACQ-5 scores were 2.42 and 2.58 and mean baseline AQLQ scores were 4.38 and 4.31 in the dupilumab and placebo groups, respectively. In the dupilumab group, asthma control improved rapidly (week 2, LS mean change from baseline in ACQ-5 score ─ 0.57, P = 0.002 versus placebo), further improved at week 12 (─ 1.01, P = 0.001 versus placebo), and remained stable through week 24 (─ 1.05, P = 0.002 versus placebo). In patients receiving dupilumab, an LS mean improvement from baseline in AQLQ score of 0.76 was observed at week 12 (P = 0.14 vs placebo), which further improved to 0.89 at week 24 (P = 0.008 versus placebo) [204] . At 24 weeks, treatment with dupilumab led to average 70% reduction in the use of maintenance oral corticosteroids compared with 42% in placebo arm (p < 0.0001). In prespecified analyses of patients with baseline eosinophil counts greater than or equal to 300 cells/microliter, addition of dupilumab resulted into significant reduction in the OCS use by 80% compared with 43% for placebo (p = 0.0001). At week 24, patients treated with dupilumab experienced 59% fewer attacks (exacerbations) in the overall population (p < 0.0001) and 71% fewer attacks in patients with eosinophil counts greater than or equal to 300 cells/microliter. Compared with placebo, dupilumab improved lung function by 15% in the overall population, and by 25% in patients with eosinophil counts greater than or equal to 300 cells/microliter (P = 0.0049). In the overall population, 80% of patients in the dupilumab arm reduced their OCS dose by at least half while maintaining overall asthma control compared to 50% of patients in the placebo arm (P < 0.0001). In patients with eosinophil counts ≥300 cells/microliter, 88% of patients in the dupilumab group reduced their OCS dose by at least half compared to 52% for placebo (P = 0.0001). In the overall population, 69% of patients who received dupilumab reduced their OCS dose to less than 5mg per day while maintaining asthma control compared to 33% of patients who received placebo (p<0.0001); in the high EOS group, 84% of dupilumab patients reduced their OCS dose to less than 5mg per day compared to 40% for placebo (P = 0.0002). Reduction of 71% was noted in FEV1 from baseline to 24 weeks. Updated results from the trial in patients administered with dupilumab 300mg q2w demonstrated that, the drug was efficient regardless of baseline blood eosinophils. OCS dose at week 24 was reduced by 70.1% versus 41.9% from baseline (p < 0.0001). In dupilumab-treated patients versus placebo at week 24: 80% versus 50% achieved ≥50% reduction in OCS, 69% versus 33% achieved reduction to <5 mg/day, 48% versus 25% no longer required OCS, and 48% versus 26% achieved their maximum OCS dose reduction. Dupilumab reduced severe exacerbations by 59.3% (p < 0.0001) and improved FEV1 by 0.22L versus placebo at week 24 (p < 0.001) [203] [381] [200] [201] . Improvements of ≥100mL and ≥200mL, in forced expiratory volume in 1 second (FEV1) at week 24 were observed in 97 (61 DPL/36 PBO) and 79 (49 DPL/30 PBO) patients. In DPL-treated patients with FEV1 improvement of ≥100mL or ≥200mL at week 24, oral corticosteroid (OCS) dose vs placebo (PBO) was reduced by 39.4%/39.9% (both P <0.001). In patients with FEV1 improvement of ≥100mL or ≥200mL, odds ratios vs PBO were 6.4/6.6 (both P <0.01) for ≥50% OCS reduction; 5.6/5.9 (both P <0.01) for OCS reduction to <5mg/day; and 3.1/3.7 (both P=0.02) for OCS elimination at week 24 [206] [202] .

Updated results from phase III EXCURSION trial in patients with Asthma which was enrolled from phase III VOYAGE trial demonstrated that improvements in pre-bronchodilator ppFEV1 were seen, and reductions in AER in response to dupilumab that were shown in the original study persisted throughout EXCURSION. At week 0, 106 patients were included in placebo/dupilumab arm and 209 in dupilumab/dupilumab arm. At week 52, change from baseline in ppFEV1 in dupilumab/dupilumab vs placebo/dupilumab was numerically greater with shorter asthma duration (interaction p- value P=0.33), older age at onset (P=0.73) and younger age at dupilumab start (P=0.84); none of these reached statistical significance. Improved lung function response was observed to dupilumab over 1-2 years of treatment in 6–11-year-old patients with uncontrolled type 2 asthma did not differ by asthma duration or age at onset or dupilumab start. Pre-bronchodilator ppFEV1 z-scores at PSBL (mean [SD]) in patients with type 2 asthma were 1.70 (1.18) in the placebo/dupilumab group and 1.84 (1.20) in the dupilumab/dupilumab group. This had improved to 0.22 (1.51), in the dupilumab/dupilumab group, by Week 52 of EXCURSION, and to 0.08 (1.59), in the placebo/dupilumab group. By Week 52, 92.4% of children in the dupilumab/dupilumab group and 93.9% of children in the placebo/dupilumab group had normal lung function (z-score > lower limit of normal, 1.64) [152] [151] . Updated results from phase III EXCURSION trial showed that efficacy observed in VOYAGE in patients with type 2 asthma was sustained in EXCURSION over an additional 52 weeks. Long-term use of dupilumab was associated with a decline in type 2 biomarkers including blood eosinophils and total serum IgE [149] . Results from the phase III LIBERTY ASTHMA EXCURSION trial open-label extension trial in Children 6 to <12 Years of age in asthma show sustained improvement in lung function, low rate of asthma attacks and a consistent safety profile for up to two years demonstrated low rate of severe asthma attacks with an average of 0.118-0.124 events per year, compared to 2.16-2.56 events per year at baseline in the pivotal trial. Children who switched from placebo in the pivotal trial to dupixent in the extension trial demonstrated improvement of 8.71 percentage points in lung function at two weeks. Sustained improvement in lung function at 52 weeks of 9.43-12.6 percentage points from baseline in the pivotal trial, measured by percent predicted FEV1 (FEV1pp). FEV1pp seeks to evaluate a patient's change in lung function compared to their predicted lung function based on age, height, sex and ethnicity to account for children's growing lung capacity at different stages of development. Unadjusted AER for patients with type 2 asthma (baseline blood eosinophils ≥ 150cells/μL or FeNO ≥ 20ppb) was 0.124 for placebo/dupilumab and 0.118 for dupilumab/dupilumab. mean parent study baseline (PSBL) in percent predicted (pp)FEV1 was 78.7% (placebo/dupilumab) and 76.9% (dupilumab/dupilumab), with mean change from PSBL at EXCURSION weeks 2/52 of +8.7/+9.4 (placebo/dupilumab), and +11.3/+12.6 (dupilumab/dupilumab). Mean PSBL ppFVC was 92.7% (placebo/dupilumab) and 91.9% (dupilumab/dupilumab), with mean change from PSBL at EXCURSION weeks 2/52 of +3.7/+4.4 (placebo/dupilumab), and +5.4/+6.9 (dupilumab/dupilumab). Mean PSBL FEV1 /FVC was 74.2% (placebo/dupilumab) and 73.4% (du- pilumab/dupilumab), with mean change from PSBL at EXCURSION weeks 2/52 of +4.6/+4.5 (placebo/dupilumab) and +5.6/+5.4 (dupilu- mab/dupilumab) [150] [148] [146]

Treatment with dupilumab 300mg showed sustained, long-term reduction in severe exacerbation rates and improved pre-bronchodilator FEV1, regardless of prior exacerbation history in patients with uncontrolled, moderate-to-severe asthma and blood eosinophil counts of ≥150 cells/µL at parent study baseline, in a LIBERTY ASTHMA TRAVERSE trial. Throughout the TRAVERSE trial, treatment with dupilumab further reduced severe exacerbation rates in patients who received dupilumab during the QUEST study, and substantially reduced severe exacerbations in those who received placebo during QUEST and initiated dupilumab in TRAVERSE (AER ≥1: 0.314 vs 0.368; AER ≥2: 0.403 vs 0.453; AER ≥3: 0.445 vs 0.545). Furthermore, dupilumab improved pre-bronchodilator FEV1 by mean change (SE) from PSBL of 0.37 (0.02) vs 0.36 (0.02) L in patients with ≥1 prior exacerbation, 0.42 (0.02) vs 0.36 (0.03) L in those with ≥2 prior exacerbations, and 0.48 (0.04) vs 0.38 (0.004) L in those with ≥3 prior exacerbations in the dupilumab/dupilumab and placebo/dupilumab groups, respectively at TRAVERSE Week 12. By Week 96, dupilumab improved pre-bronchodilator FEV1 by 0.34 (0.02) vs 0.37 (0.03) L, 0.37 (0.04) vs 0.44 (0.04) L, and 0.45 (0.05) vs 0.49 (0.07) L, in patients with ≥1, ≥2, and ≥3 prior exacerbations, respectively [196] . Updated results from the phase III LIBERTY ASTHMA TRAVERSE showed that dupilumab signicantly reduced AER, improved lung function in the placebo/dupilumab arm, and showed sustained improvement in the dupilumab/dupilumab arm regardless of prior exacerbation status. In QUEST, dupilumab signicantly reduced AER and improved lung function. During TRAVERSE, dupilumab further reduced AER in the exacerbator group (0.78 and 0.56 in dupilumab/dupilumab and placebo/dupilumab arms, respectively), and maintained low AER (0.11 and 0.17, respectively) in the non-exacerbator group. Dupilumab sustained lung function improvements during TRAVERSE. Mean (SD) ppFEV1 at TRAVERSE week 0 was 65.0 (17.3) and 73.3 (15.8) in dupilumab/dupilumab arm, and 60.4 (16.0) and 68.0 (16.0) in placebo/dupilumab arm in exacerbator and non-exacerbator groups. By week 96, dupilumab improved ppFEV1 to 67.2 (17.1) and 72.8 (16.2) in the dupilumab/dupilumab arm, and 70.8 (15.2) and 71.4 (17.3) in the placebo/dupilumab arm, respectively [195] . Updated results from the trial showed that dupilumab sustained reductions in exacerbations and improvements in FEV1 for up to 3 years in patients with uncontrolled, moderate-to-severe type 2 asthma with a history of ≥ 2 exacerbations prior to study start, regardless of evidence of allergic asthma [194] . Updated results from the phase III LIBERTY ASTHMA TRAVERSE showed that dupilumab reduced OCS dose and improved and maintained clinical efficacy outcomes of asthma, regardless of baseline OCS starting dose. As observed during VENTURE, dupilumab demonstrated persistently high reduction in OCS use without a tapering schema of reduction in TRAVERSE. The greater reductions in daily OCS use observed in patients on dupilumab at VENTURE study end continued during TRAVERSE in dupilumab/dupilumab patients (≤10 mg/day: −82.8%, >10 mg/day: −74.7% at TRAVERSE Week 48). In patients who were on placebo during VENTURE and were switched to dupilumab in TRAVERSE (placebo/dupilumab), OCS use was further reduced, irrespective of OCS use at baseline (≤10 mg/day: −49.6%, >10 mg/day: −66.5% at TRAVERSE Week 48). Despite these continued reductions in OCS use, AER continued to decline during TRAVERSE (range: 0.284-0.599) and pre-bronchodilator FEV1 greatly improved (range at TRAVERSE Week 48: 1.83-1.92L) [192] . Updated results from the phase III LIBERTY ASTHMA TRAVERSE extension trial showed that long term dupilumab treatment decreased and maintained low annualized rates of exacerbations and improved lung function. Out of 187 patients enrolled in the trial, sustained reductions (89% by Week 96) from VENTURE baseline in OCS were observed in dupilumab-dupilumab-treated patients at week 48 and week 96. Also, substantial improvements were observed in placebo-dupilumab patients (74% reduction by Week 96). In patients enrolled from QUEST with either ≥150 eosinophils/µL or FeNO ≥25ppb at baseline who completed 3 full years of dupilumab treatment, rate of severe exacerbations decreased progressively over 3 years, from 0.42 during QUEST to 0.31 and 0.23 during the first and second year of TRAVERSE, respectively. Treatment with dupilumab sustained improvement in FEV1 during TRAVERSE trial. Improvements in ACQ-5 and AQLQ scores were also maintained. Out of patients who discontinued the treatment in VENTURE study by week 24 (dupilumab-dupilumab: 53.3%, placebo-dupilumab: 29.9%), most of the patients remained OCS-free during TRAVERSE (dupilumab-dupilumab: 31/33 [93.3%] and 14/14 [100%], placebo‑dupilumab: 21/21 [100%] and 9/9 [100%] at Weeks 48 and 96, respectively). Despite reductions in OCS requirement, exacerbation rates during TRAVERSE were low and FEV1 change greatly improved [186] [190] . Earlier results demonstarted long-term efficacy with dupilumab in asthma patients with and without an allergic phenotype, supporting the efficacy seen in the parent studies. Patients who switched from placebo to dupilumab for the open-label extension (OLE) showed similar lung function benefits and exacerbation reductions to those originally on dupilumab, confirming the early dupilumab results from LIBERTY ASTHMA QUEST trial. 9.7% of QUEST patients completed the OLE. Dupilumab treatment in QUEST resulted in lower unadjusted asthma exacerbations (AER) vs placebo in allergic (0.520 vs 0.964) and non-allergic (0.521 vs 1.134) patients. AER were further reduced with dupilumab during the OLE regardless of patients’ allergic status or QUEST treatment regimen (dupilumab- dupilumab/placebo-dupilumab, allergic: 0.332/0.375; non-allergic: 0.330/0.321). LS mean improvement in FEV 1 during QUEST (dupilumab vs placebo) of 0.36L vs 0.19L and 0.35L vs 0.19L for allergic and non- allergic patients, respectively, continued during the OLE with LS mean changes at Week 96 for dupilumab-dupilumab/placebo-dupilumab of 0.39L/0.33L and 0.35L/0.39L in allergic and non-allergic patients, respectively [187] [188] . Previous results from the phase III LIBERTY ASTHMA TRAVERSE extension trial demonstrated that, patients continued to experience improvement in lung function by 13-22% at 96 weeks, as measured by the average change in forced expiratory volume over one second (FEV1) compared to baseline for the initial asthma trials. Patients maintained a low rate of severe asthma attacks (unadjusted annualized severe exacerbation rate) with an average of 0.31-0.35 events per year. Improvements in lung function and asthma attacks were greater in those with elevated baseline blood eosinophils or fractional exhaled nitric oxide (FeNO), which are markers of type 2 inflammation. Patients showed reductions in blood eosinophils (23-35%) and in blood IgE for the patients from the pivotal phase IIb trial (82%) compared to baseline for the initial asthma trials. The trial was conducted in 2282 patients with moderate-to-severe asthma who had previously participated in a controlled dupixent clinical trial, including the pivotal phase IIb DRI (24 weeks) and phase III QUEST (52 weeks) trials in patients with moderate-to-severe asthma and the phase III VENTURE (24 weeks) trial in patients with severe oral corticosteroid (OCS)-dependent asthma [189] [172] .

Updated results from the phase III LIBERTY ASTHMA VOYAGE trial demonstrated that in the type 2 asthma population at Week 12, pre-BD ppFEV1 significantly improved with dupilumab compared to placebo (LSM difference [95% CI] 5.21 percentage points [2.14-8.27]; P = 0.0009). In comparison to placebo, which had a 50% success rate (n = 57; [40.5-59.5]), dupilumab had a 59.7% success rate (n = 141; [95% CI 53.2-66.1]) in terms of patients who improved their ppFEV1 by at least 5%. A 10% ppFEV1 improvement was attained in 44.9% (n = 106; [38.5-51.5]) of the dupilumab-treated patients compared to 31.6% (n = 36; [23.2-40.9]) of the placebo-treated individuals [167] . Earlier results from the phase III LIBERTY ASTHMA VOYAGE trial in patients with baseline blood eosinophils ≥ 500 cells/μL, add-on dupilumab signicantly lowered annualized exacerbation rates (0.249 [95% CI 0.156–0.397]; n = 126) compared with add-on placebo (0.749 [0.453–1.239]; P<0.001; n = 48) and signicantly improved pre- BD ppFEV1 vs placebo (LSM difference [95% CI] 7.98 percentage points [2.17–13.78]; P< 0.01) at Week 52 in this population. Dupilumab signicantly reduced severe exacerbations and improved lung function as assessed by pre-BD ppFEV1 vs placebo in children with moderate-to-severe asthma and baseline blood eosinophils ≥ 500 cells/μL [166] The previously updated results from the phase III LIBERTY ASTHMA VOYAGE trial, baseline annualized severe exacerbation rate (AER) in dupilumab/placebo (DPL/PBO) patients were 3.04/2.56 in the high and 2.28/1.88 in the med ICS groups. DPL vs PBO significantly reduced AER in the med (59.5%; P=0.0025) and high (63.3%; P=0.0004) groups. LS mean change from BL in pre-BD ppFEV1 at Wk12 was significantly greater in DPL vs PBO in the med ICS group (LS mean diff. 7.19 [3.15, 11.22]; P=0.0006) and numerically greater in the high ICS group [164] Results showed that in the dupilumab group, the AER was low and was independent of baseline values of FeNO and blood eosinophils. Conversely, in the placebo group, both higher baseline FeNO and blood eosinophils were associated with a higher AER. In the dupilumab group, higher values of FeNO and blood eosinophils each were associated with a greater improvement in ppFEV1. In the placebo group, higher baseline eosinophil count (but not FeNO) was associated with smaller improvements in ppFEV1 [165] Earlier, updated results from the phase III LIBERTY ASTHMA VOYAGE trial showed that dupilumab reduced severe exacerbation rates and by the end of treatment, had improved the percent predicted pre-bronchodilator FEV1 in children aged 6 to 11 years with uncontrolled, moderate-to-severe asthma, in patients with or without atopic comorbidities. Dupilumab vs placebo reduced AER by 72% (no comorbid disease; P = 0.07), 2% (1 ongoing comorbid disease; P = 0.96), and 69% (>1 ongoing comorbid diseases; P < 0.001). At Week 12, patients with no atopic comorbidities showed no differences in changes from baseline in pre-bronchodilator FEV1pp; however, dupilumab vs placebo improved pre-bronchodilator FEV1pp in patients with atopic comorbidities (least square mean difference [LSMD] [95% CI]: 1 comorbid disease: 5.37% [−0.18%, 10.93%]; P = 0.06; >1 comorbid disease: 5.34% [1.58%, 9.11%]; P = 0.006). At study end (Week 52), dupilumab improved the change from baseline in pre-bronchodilator FEV1pp in all patients (LSMD vs placebo [95% CI]: no comorbidites: 7.86% [0.21%, 15.51%]; P = 0.044; 1 comorbid disease: 5.87% [−0.64%, 12.38%]; P = 0.077; >1 comorbid disease: 7.26% [3.17%, 11.36%]; P < 0.001) [163] . Updated data from the phase III LIBERTY ASTHMA VOYAGE trial demonstrated that dupilumab increased the proportion of paediatric patients with improved lung function, in both the type 2 diabetes population as well as the eosinophil (Eos) ≥300 subpopulation. At week 52, % predicted FEV1 ≥ 95% and % predicted FEV1 ≥ 80% increased in dupilumab treated patients from 8.1% to 34.9% and from 50.8% to 77.2%, respectively, compared with placebo with increase from 12.3% to 20.8% and from 48.2% to 66%, respectively. At week 52, 22.8% of patients treated with dupilumab continued to have % predicted FEV1 <80%, compared with 34% of patients in placebo group [162] . Earlier data from the trial showed that dupilumab vs placebo significantly reduced annualised severe exacerbation rate (AER) in patients with/without allergic phenotype. Change from baseline in % predicted pre-BD FEV1 at Week 12 and ACQ-7 at Week 24 was greater in patients treated with dupilumab vs placebo in both groups. Efficacy on lung function was similar in both groups. Dupilumab rapidly improved asthma control in children with uncontrolled T2 asthma, by Week 4 and the control was sustained to Week 52 (p<0.05). At Week 24, 79% dupilumab vs 69% placebo patients were ACQ-7-IA responders and 61% dupilumab vs 43% placebo achieved well-controlled asthma (p<0.05). From Week 36, dupilumab vs placebo significantly improved PAQLQ[S]-IA scores across all domains—symptoms, activity limitation, emotional. A higher proportion of dupilumab vs placebo patients were PAQLQ[S]-IA responders at Week 52 (p<0.05). Updated results from the trial demonstrated improvement in efficacy in asthma patients, receiving dupilumab. Dupixent, when added to standard of care, significantly reduced severe asthma attacks and, within two weeks, rapidly improved lung function in populations with an eosinophilic phenotype, as indicated by elevated blood eosinophils, a certain type of white blood cell, and/or with elevated fractional exhaled nitric oxide (FeNO). Treatment with dupilumab reduced exacerbation rate by 59.3% (P<0.0001), and improved percent predicted FEV1 (least squares [LS] mean difference vs placebo 5.21%; P=0.0009) and reduced fractional exhaled nitric oxide (FeNO) levels (LS mean difference vs placebo −17.84ppb; p < 0.0001) at week 12 compared with placebo. At week 24, dupilumab showed greater improvement in Asthma Control Questionnaire-Interviewer Administered (ACQ-7-IA) scores from baseline vs placebo (LS mean difference vs placebo −0.33, P=0.0001). Similar findings were observed in patients with eosinophils ≥300cells/µL. Earlier results from the trial, demonstrated significant improvement in asthma control at week 24, on treatment with dupilumab. Improvement in asthma scores were reported to be 1.34 and 1.33 with dupilumab and 0.88 and 1.00 for placebo (average improvement of -0.46 and -0.33 for dupixent and placebo, p<0.0001 and p=0.0001, respectively). Average improvement in FeNO levels was reported to be -20.59 and -17.84 ppb for dupixent and placebo from baseline to week 12 (p<0.0001 for both values). Treatment with dupilumab SC significantly reduced severe asthma attacks by up to 65% over one year, compared with placebo, in the trial, in children (n=408), aged 6 to 11 years. Across two patient groups respectively, those who added dupilumab (100mg or 200mg every two weeks, based on weight) to standard of care experienced, reduced rate of severe asthma attacks, with a 65% (p<0.0001) and 59% (p<0.0001) average reduction over one year, compared to placebo (0.24 and 0.31 events per year for dupilumab vs. 0.67 and 0.75 for placebo, respectively). Improved lung function at 12 weeks compared to baseline by 10.15 and 10.53 percentage points for dupilumab vs. 4.83 and 5.32 percentage points for placebo (least squares mean difference for dupilumab vs. placebo of 5.3 and 5.2 percentage points, p=0.0036 and p=0.0009), respectively, as measured by percent predicted FEV1 (FEV1pp). This clinically meaningful improvement in lung function was observed as early as two weeks and was sustained for up to 52 weeks [159] [160] [153] [154] [155] [156] [157] .

Data from the phase III LIBERTY ASTHMA QUEST trial showed that, dupilumab significantly improved pre-bronchodilator FEV1 and reduced severe exacerbation rates in patients with type 2 asthma with and without an allergic phenotype and who were receiving high-dose ICS as compared to placebo [183] . Updated data from the phase III LIBERTY ASTHMA QUEST trial demonstarated that dupilumab reduced severe exacerbations and improved lung function in patients with uncontrolled, moderate-to-severe asthma with a type 2 phenotype defined by multiple parameters as per GINA guidelines. Baseline characteristics were generally similar across treatment groups. In patients with GINA-defined type 2 asthma, dupilumab combined (n = 337) vs placebo (n = 197) reduced severe exacerbations by 57.4% (95% CI: 42.0–68.8; 0.0001), and improved FEV 1 (least squares mean difference at Week 12 [95% CI]: 0.24L [0.16–0.31]; 0.0001) [176] . Previous data from the phase III LIBERTY ASTHMA QUEST trial in n=1902 pts (1,264 dupilumab/638 Placebo) showed that during the 52-wk treatment period, dupilumab reduced severe exacerbations and improved forced FEV1 in asthma patients, except FEV1 for DPL 300 mg in IgE <100 IU/mL group. Across all baseline BMI subgroups, both DPL 200 and 300 mg q2w vs placebo consistently reduced severe exacerbations (–35.1 to –51.4%; all P<0.05) and improved FEV1 at week 12 (LSM difference: 0.09–0.17; all P<0.05 except in the 25–<30 kg/m2 subgroup treated with 200 mg [P=0.09]) [178] . Dupilumab significantly improved pre-bronchodilator lung function parameters of both large and small airways. The improvement occurred as early as weeek 2 and was sustained over the 52-week treatment period. The patients in the dupilumab groups demonstrated improvement from baseline in post-bronchodilator FEV1 at all time points, while little to no change in patients in the placebo groups. Dupilumab at 200mg and 300mg q2w significantly improved LS mean change from baseline in post-bronchodilator FEV1 starting at week 2 and at all other time points (all P < 0.0001) as compared to placebo . Dupilumab also significantly improved LS mean change from baseline in pre-bronchodilator FEV1 and FEF25-75% at all time points starting at week 2 (P < 0.001) at 200mg and 300mg respectively as compared to placebo [182] . In 517 patients, dupilumab 200/300mg q2w reduced annualised severe exacerbation rates by 44%/51% respectively versus placebo (P=0.06/P=0.01). Dupilumab c200/300mg q2w compared with placebo also improved FEV1 at week 12 with a LS mean difference of 0.11L/0.09L, respectively (P=0.01/P=0.05). At weeks 24 and 52 in all baseline IgE groups (–38.9 to –67.9%; all p < 0.05) a significant reduction in severe exacerbations as well as pre-bronchodilator (pre-BD) FEV1 (LSM difference: 0.11–0.31 L; all p < 0.05) was demonstrated by dupilumab at a dose of 200/300mg q2w compared with placebo. At week 12, dupilumab 200mg /300mg q2w compared with placebo improved lung function parameters (change from BL LS mean difference pre-BD FEV1 0.13/0.16L; post-BD FEV1 0.13/0.11L; FEF25–75 0.14/0.22L/s; FVC 0.15/0.11L; FEV1/FVC ratio 0.56/2.78%, all p < 0.05 except DPL 200mg, FEV1/FVC ratio [P = 0.35]). At week 52, sustained or better improvements were observed (all p < 0.05). The 300mg dupilumab, reduced the rate of severe asthma attacks at 52 weeks, by 46%, 60% and 67%, in overall population, in patients with 150 eosinophilic cells/µl or greater and in patients with 300 eosinophilic cells/µl or greater, respectively (p < 0.001). At 12 weeks, in the 300 mg dupilumab dose group, improvement in the lung function as assessed by forced expiratory volume over one second (FEV1) of 130ml (9%), 150ml (11%) and 240ml (18%), in overall population, in patients with 150 eosinophilic cells/µl or greater and in patients with 300 eosinophilic cells/µl or greater, respectively (p < 0.001). The group receiving 200mg dose showed comparable results for exacerbations and FEV1. In the double-blind, placebo-controlled trial, 1902 patients were randomised 2:1, to receive either 200mg or 300 mg dupilumab, every other week or placebo. The trial also evaluated the effect of dupilumab on the Standardized Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)+12] in patients with self-reported medical history of comorbid allergic rhinitis (63.55; 207/1902).The RQLQ score was significantly improved by dupilumab in comparison to placebo at week 52 with a baseline mean standard deviation of 1.90 [1.12]- 2.01[1.16], least squares mean difference of -0.42[-0.61, -0.24] and -039[-0.56,-0.21], respectively, 95% CI and p < 0.001. At week 52, Dupilumab significantly (p < 0.001) improved activities (−0.44[−0.68,−0.21]/−0.39[−0.61,−0.16]), sleep (−0.47[−0.69,−0.25]/−0.38[−0.59,−0.17]), and eye symptoms (−0.37[−0.58,−0.16]/−0.39[−0.59,−0.19]) domain scores from baseline compared to placebo; and by week 12 for dupilumab (−0.23[−0.42,−0.04], −0.26[−0.45,−0.07], −0.26[−0.45,−0.08] respectively; p < 0.05). Nasal symptoms domain scores also improved significantly with dupilumab in comparison to placebo by week 12 (−0.36[−0.56,−0.16]/−0.32[−0.51,−0.13];p < 0.001) and week 52 (−0.61[−0.84,−0.39]/−0.55[−0.76,−0.33];p < 0.0001) respectively. The improvement in FEV1 is observed to be associated with greater reductions in FeNO levels in drug treated and placebo group at week 52 with duilumab showing higher lung functions [184] [179] [180] [181] [175] [383] [173] [171] .

In a phase III trial in patients with persistent asthma and type 2 inflammation without oral corticosteroids maintenance, dupilumab treatment showed that in the primary population (n=414), DPL significantly increased pre-BD FEV1 at week 12 vs PBO (least squares mean difference, LSMD [95% CI] 0.31 [0.23,0.39] L; P<0.0001) and reduced ACQ-5 scores at week 24 (LSMD [95% CI] −0.20 [−0.35,−0.05] L; P=0.0097). There was a 62% relative reduction in AER during the study with DPL vs PBO (P=0.002) [145] . Earlier, results showed that the study led to sustained improvement in lung function and asthma control and reduced severe exacerbations. In the primary population, dupilumab treatment significantly increased pre-BD FEV1 at Week 12 vs placebo (least squares (LS) mean change [SE] 0.37 [0.04] vs 0.06 [0.04] L; LS mean difference (LSMD) [95% CI] 0.31 [0.23, 0.39] L; P < 0.0001) and reduced ACQ-5 scores at Week 24 vs placebo (LS mean change [SE] −1.29 [−0.07] vs −1.09 [−0.06]; LSMD [95% CI] −0.20 [−0.35, −0.05] L; P = 0.0097). In this trial, of 486 participants (intention-to-treat [ITT] population), 414 had type 2 inflammation and were not receiving OCS (primary population), 35 were receiving OCS, and 37 were not type 2 and not receiving OCS. There was a 62% relative reduction in AER during the treatment period in the dupilumab group compared with placebo (P = 0.002) [144] [143] .

Pooled analysis: Updated pooled analysis data from the phase III LIBERTY ASTHMA QUEST and LIBERTY ASTHMA TRAVERSE trial demonstrated that after treatment with dupilumab, reductions in annualised rate of severe exacerbations (AER) were observed in patients with asthma. The reductions in AER were sustained through TRAVERSE trial for up to three years for patients with and without a minimally important fractional exhaled nitric oxide (FeNO) at week two of the QUEST trial, with greater numerical improvements in those with a minimally important FeNO reduction. By the end of TRAVERSE trial, a decrease in AER from 0.392 to 0.209 and 0.523 to 0.284 was observed in patients with (n = 367) and without (n = 102) a minimally important FeNO reduction, respectively. A change from baseline in forced expiratory volume (FEV1) was 0.475 L and 0.379 L by the end of QUEST trial and 0.453L and 0.306L by the end of TRAVERSE trial, for patients with and without a minimally important FeNO reduction, respectively. The improvements in FEV1 in the dupilumab/dupilumab treatment arm were maintained throughout the TRAVERSE trial. AER reduced further in DPL/DPL and substantially reduced in PBO/DPL pts in TRAVERSE: ≥1 (0.301 vs 0.344), ≥2 (0.376 vs 0.398) or ≥3 (0.365 vs 0.454) prior exacerbations. Mean change in FEV1 (PBO/DPL vs DPL/DPL) was 0.40 vs 0.41, 0.45 vs 0.47 and 0.45 vs 0.49 at TRAVERSE Week 48 in pts with ≥1, ≥2 or ≥3 prior exacerbations, respectively, and 0.38 vs 0.35, 0.45 vs 0.39 and 0.48 vs 0.44 at Week 96803802943 [168] [170] [171] [172] .

Chronic obstructive pulmonary disease:

Phase III:

Results from phase III BOREAS trial showed that dupilumab met all multiplicity-adjusted endpoints. The dupilumab group experienced a 30% reduction in the annualized rate of moderate-to-severe exacerbations (p=0.0005). Dupilumab treatment significantly increased pre-BD FEV1 at Week 12 vs placebo (least squares mean (LSM) difference vs placebo: 83 mL,p<.0001); sustained through Week 52 (83 mL, p=0.0003). Dupilumab led to statistically significant and clinically meaningful improvement in SGRQ at Week52 (p=0.0017), proportion of SGRQ responders with improvement ≥4 points (p=0.0089), and E-RS: COPD RS-Total Score at Week52 (p=0.0012). 939 participants were randomized to placebo (N=471) or dupilumab (N=468) [230] . The phase III BOREAS trial in patients with moderate-to severe COPD, with type 2 inflammation, dupilumab met the primary and all key secondary endpoints. The updated efficacy results showed that there was numerical improvement in dupilumab (153 mL) compared to placebo (70mL) at week 52 ( p<0.001). In health related quality of life, there was 9.7 point improvement from baseline at week 52 (p=0.002). The improvement was seen from four weeks. In respiration symptom severity, there was 2.7-point reduction observed from baseline as compared to placebo (p=0.001). Previously the results demonstrated a clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations of COPD (rapid and acute worsening of respiratory symptoms) over 52 weeks (p=0.0005). The study showed an improved lung function from baseline by 160 mL at 12 weeks compared to 77 mL for placebo (p<0.0001), with the benefit versus placebo sustained through week 52 (p=0.0003), both of which were key secondary endpoints [228] [229] [226] .

Phase III:

Results from the phase III NOTUS trial met primary endpoint showing dupixent significantly reduced exacerbations by 34% compared to placebo in patients with moderate-to-severe COPD with evidence of type 2 inflammation (i.e., blood eosinophils =300 cells per µL) over 52 weeks (p=0.0002). Improved lung function was observed from baseline by 139 mL at 12 weeks compared to 57 mL for placebo (p=0.0001), with the benefit versus placebo sustained at week 52 (115 mL for dupixent versus 54 mL for placebo, p=0.0182). Dupixent rapidly and significantly improved lung function (139 mL in FEV1) compared to placebo (57 mL in FEV1) at 12 weeks [224] [225] .

Atopic dermatitis

Phase III:

The updated results of the phase III CHRONOS study demonstrated increase in total IgE levels and in the probability of having ares over time, while patients treated with dupilumab show a decrease in total IgE levels. Most patients treated with placebo had an increase in total IgE levels after 52 weeks (65% had an increased ratio change in total IgE from baseline), while most treated with dupilumab had a decrease in total IgE levels (81% with a ratio change reduction from baseline). The dupilumab-mediated reduction in total IgE corresponded with a reduced probability of having ares over 52 weeks, whilst with placebo an increase in total IgE levels was associated with an increased probability of having ares (parameter estimate with CI-95%, 50.40 in placebo and 1.91 at P<0.05 for dupilumab) [87] . One year treatment with combination of dupilumab and topical corticosteroids (TCS) significantly improved measures of overall disease severity at week 16 and week 52 as compared with TCS alone in patients with inadequately controlled moderate-to-severe atopic dermatitis in the phase III LIBERTY AD CHRONOS trial. At 16 weeks, the mean percent improvement in EASI from baseline was 77% for patients who received dupilumab weekly with TCS and for patients who received dupilumab every two weeks with TCS, compared to 42% for patients receiving placebo with TCS (p < 0.0001). At 16 weeks, 69% of patients in dupilumab plus TCS arm achieved a 75 per cent reduction in their EASI as compared with 23% of patients in placebo plus TCS arm. At 16 weeks, a greater number of patients saw a clinically important improvement of ≥ 4 points on the Pruritus NRS from baseline to week 16 and week 52 as compared with placebo + TCS [43] . At 16 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), was 55% for patients who received dupilumab weekly with TCS and 58% for patients who received dupilumab every two weeks with TCS, compared to 29% for patients receiving placebo with TCS (p < 0.0001). At 16 weeks, 77% of patients who received dupilumab weekly with TCS or dupilumab every two weeks with TCS achieved a =4-point improvement in the severity of their AD, as measured by the Patient Oriented Eczema Measure (POEM), a tool that quantifies the illness as experienced by the patients, compared to 37% of patients receiving placebo with TCS (p < 0.0001) At 16 weeks, 74% of patients who received dupilumab weekly with TCS and 81% of patients who received dupilumab every two weeks with TCS achieved a >=4-point improvement in aspects of their quality of life, as measured by the Dermatology Life Quality Index (DLQI), compared to 43% of patients receiving placebo with TCS (p < 0.0001). Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. At 52 weeks, the mean percent improvement in EASI from baseline was 80% for patients who received dupilumab weekly with TCS and 78% for patients who received dupilumab every two weeks with TCS, compared to 46% for patients receiving placebo with TCS (p < 0.0001). At 52 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the NRS, was 54% for patients who received dupilumab weekly with TCS and 56% for patients who received dupilumab every two weeks with TCS, compared to 27% for patients receiving placebo with TCS (p < 0.0001). At 52 weeks, 65% of patients who received dupilumab weekly with TCS and 76% of patients who received dupilumab every two weeks with TCS achieved a =4-point improvement in the severity of their AD, as measured by POEM, compared to 26% of patients receiving placebo with TCS (p < 0.0001). At 52 weeks, 63% of patients who received dupilumab weekly with TCS and 80% of patients who received dupilumab every two weeks with TCS achieved a =4-point improvement their quality of life, as measured by the DLQI, compared to 30% of patients receiving placebo with TCS (p < 0.0001) [82] [83] [86] .

Results from the phase III CAFE study in patients (n = 325) with moderate-to-severe atopic dermatitis demonstrated that dupilumab with topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearing, itching, and patient reported quality of life measures. Fifty-nine percent of patients receiving dupilumab weekly with TCS, and 63% of patients who received dupilumab every two weeks with TCS achieved EASI-75, when compared with 30% of those patients who received placebo with TCS (p < 0.0001). The mean percent change improvement in EASI from baseline at 16 weeks was 78% and 80% for patients who received dupilumab weekly or every two weeks with TCS, respectively, compared to 47% for those who received placebo plus TCS (p <0.0001). Mean improvement from baseline in the intensity of patient-reported itch, as measured by the pruritus Numerical Rating Scale (NRS), was 52% and 54% in patients who received dupilumab weekly or every two weeks with TCS, respectively, compared to 25% for those who received placebo plus TCS (p <0.0001). The proportion of patients with a ≥ four-point improvement from baseline in aspects of patient quality of life, as measured by the Dermatology Life Quality Index (DLQI), was 78% and 88% in patients who received dupilumab weekly or every two weeks with TCS, respectively, when compared with 44% of those who received placebo plus TCS (p <0.0001). The proportion of patients with a ≥ four-point improvement from baseline in the severity of their AD, as measured by the Patient Oriented Eczema Measure (POEM), was 76% and 83% in patients who received dupilumab weekly or every two weeks with TCS, respectively, compared to 42% for those who received placebo plus TCS (p <0.0001) [73] [74] [72] .

The results from a phase III open-label trial demonstrated that the early and sustained improvement in AD signs was observed as 55.1%/27.2% of patients achieving EASI-75/EASI-90 at week 4, 70.6%/ 44.1% at week 8, and 91.3%/72.8% at end of study, vs 16.6%/7.8% at OLE BL. Similar improvement in AD symptoms was reported as 46.1% of patients achieving >_4-point Pruritus NRS reduction at week 4, 55.7% at week 8, and 60.7% at week 260, vs 17.4% at OLE BL [93] . The results from a phase III open-label trial in patients with moderate-to-severe atopic dermatitis demonstrated continued efficacy by sustained improvement of AD signs and symptoms (including skin lesions and pruritus) in adult patients with moderate-to-severe AD [92] . Previous results from a phase III open-label trial in patients with moderate-to-severe atopic dermatitis, Investigator’s Global Assessment 0-1 was reported in 48.6% patients and 75.4% achieved ≥75% reductions in Eczema Area and Severity Index (missing values as non-responders for both outcomes). Pruritus Numerical Rating Scale scores was reported to have decreased by 62.24% (calculated based on observed values). The data were presented from 1491 patients [89] [88] .

In two phase III SOLO 1 and SOLO 2 trials, respectively, 37 and 36 percent of patients who received dupilumab 300 mg weekly, and 38 and 36 percent of patients who received dupilumab 300mg every two weeks, achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 10 and 8 percent with placebo (p < 0.0001). With these results, the primary endpoint of the study in US and one of the primary endpoints in the EU, was met. Further, percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received dupilumab 300 mg every two weeks, compared to 38 and 31 percent for placebo (p < 0.0001), in SOLO 1 and SOLO 2, respectively. Additionally, for both trials, respectively, 52 and 48 percent of patients who received dupilumab 300 mg weekly, and 51 and 44 percent of patients who received dupilumab 300mg every two weeks, achieved EASI-75 compared to 15 and 12 percent with placebo (p < 0.0001). These results confirmed that the key secondary endpoint in the US, and one of the primary endpoints in the EU was met. The secondary endpoint of a reduction in daily intensity of patient itching, as measured by the Pruritus Numerical Rating Scale (0-no itch; 10-worst itch imaginable), was met at 2 weeks, 4 weeks and 16 weeks. For the SOLO 1 and SOLO 2 trials, at 16 weeks, respectively, 40 and 39 percent of patients who received dupilumab 300mg weekly, and 41 and 36 percent of patients who received the drug 300mg every two weeks, achieved a four-point or greater reduction in their NRS score, as compared with 12 and 10 percent with placebo (p < 0.001). At 16 weeks, a significantly greater proportion of patients in dupilumab arm achieved an IGA 0 or 1 response and a 75 percent reduction in EASI [43] [79] [377] [94] [80] .

Results from a phase III trial of dupilumab monotherapy in patients with moderate-to-severe atopic dermatitis demonstrated significant improvement in disease severity at 16 weeks. The primary endpoint of Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) was achieved at 16 weeks by 24% of patients who received weight-based dosing of dupilumab every two weeks (200 mg or 300 mg) and 18% of patients who received a fixed dose of dupilumab every four weeks (300 mg), when compared with 2% with placebo treated patients (p < 0.0001, and p = 0.0007, respectively). The co-primary endpoint of 75% improvement in Eczema Area and Severity Index (EASI-75) at 16 weeks, was achieved by 41.5% of patients who received dupilumab every two weeks and 38% of patients who received dupilumab every four weeks, when compared with 8% with placebo arm (p < 0.0001). A 66% improvement in the dupilumab every two weeks group and, 65% improvement in the dupilumab every four weeks group was seen in average percent change from baseline in EASI score, when compared with a 24% improvement in the placebo group (p < 0.0001). A 48% improvement in the dupilumab every two weeks group and 45.5% improvement in the dupilumab every four weeks group was observed in average percent change from baseline in the pruritus numerical rating scale (NRS), when compared with a 19% improvement in the placebo group (p < 0.0001). A 3-point improvement on the peak pruritus numerical rating scale (pp-NRS) was achieved by 49% and 39% of the patients who received dupilumab every two weeks and every four weeks, respectively. A mean itch score of 7.6 on the 10-point pp-NRS scale was reported by the at the beginning of the trial. Additionally,mean percent change from baseline in SCORing Atopic Dermatitis (SCORAD) demonstrated a 52% improvement in the dupilumab every two weeks group and 47.5% improvement in the dupilumab every four weeks group compared to a 18% improvement in the placebo group (p <0.001) was demonstrated by . Patients who received dupilumab every two weeks or every four weeks showed improved quality of life measured by the Children's Dermatology Life Quality Index (CDLQI) and patient-reported symptoms measured by the Patient-Oriented Eczema Measure (POEM) compared with placebo (p <0.001). The results were reported from 251 adolescent patients of ages 12-17 years [97] [98] [99] [100] [96] .

In a phase III trial, efficacy of dupilumab was consistent with known profile of dupilumab in atopic dermatitis at one year [71] . Dupilumab improved signs and symptoms of severe atopic dermatitis in children aged 6 to 11 years with and without comorbid asthma. At Week 16, in both subgroups (300mg dupilumab q4w and 100/200mg dupilumab q2w), signicantly more patients receiving dupilumab q4w/q2w vs placebo achieved Investigators Global Assessment score 0/1 (with asthma:37.9%/27.0% vs 11.7%; without asthma:28.1%/32.2% vs 11.1%), > 75% improvement in Eczema Area and Severity Index (with asthma:65.5%/58.7% vs 25.0%; without asthma:73.4%/76.3% vs 28.6%), and > 4-point reduction from baseline in Peak Pruritus Numerical Rating Scale (with asthma:48.3%/50.8% vs 8.5%; without asthma:53.2%/66.1% vs 15.9%); 0.05 for all comparisons [70] [66] . 16 weeks of data demonstrated that, at baseline n=75, n=75 and n=77 patients in q4w/q2w/placebo groups reported a history of allergic rhinitis (AR) and 47/47/46 patients had no AR history. Baseline disease severity was comparable in both subgroups. The patients receiving dupilumab q4w/q2w vs placebo achieved Investigator’s Global Assessment (IGA) score 0/1 (with allergic rhinitis:32.0%/30.7% vs 9.1%; without allergic rhinitis:34.0%/27.7% vs 15.2%), > 75% improvement in Eczema Area and Severity Index (with allergic rhinitis:68.0%/69.3% vs 20.8%; without allergic rhinitis:72.3%/ 63.8% vs 37.0%), and > 4-point reduction from baseline in Peak Pruritus Numerical Rating Scale (with allergic rhinitis:50.0%/56.2% vs 13.2%; without allergic rhinitis:52.2%/61.7% vs 10.9%) and all the groups had shown significant results with P=0.05 except q2w vs placebo for IGA in patients without allergic rhinitis which was shown insignificant results [69] . 16 weeks data from a phase III trial for atopic dermatitis showed that 30% of patients who received Dupixent every four weeks (300 mg) and 39% of patients who received Dupixent every two weeks (100 mg or 200 mg) achieved clear or almost clear skin compared to 13% and 10% for TCS alone (p<0.0001 and p=0.0004, respectively), meeting the endpoint. Also, 75% of patients who received Dupixent every four weeks and 75% of patients who received Dupixent every two weeks achieved EASI-75 (Eczema Area and Severity Index-75), compared to 28% and 26% for TCS alone (p<0.0001 for both). The average EASI score improvement from baseline was 84% in patients who received Dupixent every four weeks and 80% in patients who received Dupixent every two weeks, compared to 49% and 48% for TCS alone respectively (p<0.0001 for both). 54% of patients who received Dupixent every four weeks and 61% of patients who received Dupixent every two weeks experienced at least a 4-point reduction in itch intensity on a 0 to 10-point scale (weekly average of daily Peak Pruritus Numerical Rating Scale), compared to 12% and 13% for TCS alone, respectively [21] [68] . Earlier data demonstrated a 75% or greater skin improvement (EASI-75) in 70% of patients receiving dupilumab every four weeks and 67% of patients receiving dupilumab every two weeks, compared to 27% for placebo (p<0.0001 for both). Clear or almost clear skin (IGA; score of 0 or 1), was reported in 33% of patients receiving dupilumab every four weeks and 30% of patients receiving dupilumab every two weeks, compared to 11% for placebo (p<0.0001 and p=0.0004, respectively). The average EASI score improvement from baseline was reported to be 82% in the dupilumab every four weeks group and 78% in the dupilumab every two weeks group, compared to 49% for placebo (p<0.0001 for both). Further a significant improvement in itch relief, anxiety, depression and health-related quality of life was reported with dupilumab treatment [67] [66] .

Updated results of the randomised, double-blind, phase III LIBERTY AD SOLO-CONTINUE trial in patients with atopic dermatitis demonstrated that maintenance treatment with dupilumab monotherapy resulted in significantly improved patient perception of well-being and of treatment effect over one year of treatment, when compared with patients randomized from dupilumab to placebo. In patients who switched to placebo after 16 weeks of dupilumab treatment, these effects progressively declined, suggesting that continued treatment with dupilumab had an impact on maintenance of treatment benefit [78] . Interim results of the Liberty AD Solo-Continue trial, treatment with dupilumab demonstrated a 75% or greater skin improvement compared to 8% with placebo, as measured by the Eczema Area and Severity Index (EASI-75). Clear or almost clear skin was reported in 24% of patients compared to 2% with placebo, as measured by an Investigator's Global Assessment (IGA) score of 0 or 1. A 66% average improvement in the EASI score of skin inflammation from baseline was reported as compared to 24% for placebo. A clinically meaningful improvement in itch of at least four points was reported in 37% of patients, as measured on the Peak Pruritus Numerical Rating Scale (NRS) compared to 5% with placebo. A clinically meaningful improvement in quality of life of at least six points was reported in 61% of patients, as measured on the Children's Dermatology Life Quality Index (CDLQI) compared to 20% with placebo. A clinically meaningful improvement in disease severity of at least six points was reported in 63% of patients, as measured on the Patient Oriented Eczema Measure (POEM), that includes sleep, compared to 10% with placebo [35] [77] .

The updated results from phase III LIBERTY AD PRESCHOOL trial demonstrated that dupilumab with concomitant topical corticosteroids (TCS) was equally efficacious in improving AD signs and symptoms in children aged 6 months to 5 years with and without a history of type 2 comorbidities [109] . The updated results from phase III LIBERTY AD PRESCHOOL trial demonstrated that after 16 weeks of administration of dupilumab, a significant improvement was observed in sleep quality NRS scores (SE) when compared to placebo in patients aged 6 months to 5 years (2.0 [0.3] vs 0.3 [0.3]; P < 0.0001) and in caregivers (1.8 [0.3] vs 0.3 [0.3]; P < 0.0001). A significant correlation was observed in weekly sleep quality NRS score in caregiver-/patient-reported outcomes which includes Infants’ Dermatitis Quality of Life Index (IDQoL; Pearson ρ [95% CI]; -0.55 [-0.71, -0.32]; P < 0.05), Children’s Dermatology Life Quality Index (CDLQI; -0.52 [-0.66, -0.33]; P < 0.05), and Skin Pain NRS (-0.52 [-0.63, -0.38]; P < 0.05) [62] . Previous updated results from the pivotal phase III LIBERTY AD PRESCHOOL trial demonstrated Global assessment score 0 or 1 (with asthma: 23.8%/0%; without asthma, 29%/5.4%; with allergic rhinitis: 24.3%/ 0.1%; without allergic rhinitis: 30.4%/7.2%; with food allergies, 25.4%/1.8%; without food allergies: 33.3%/9.3%). At Week 16, signicantly more patients receiving dupilumab vs placebo achieved ≥ 75% improvement in Eczema Area and Severity Index (with asthma: 52.4%/4.5%; without asthma: 53.2%/13.1%; with allergic rhinitis: 54.1%/ 3.2%; without allergic rhinitis: 52.2%/17.3%; with food allergies: 44.1%/ 7.5%; without food allergies: 75%/19.1%). Dupilumab with concomitant TCS was equally efcacious in improving AD signs in children aged 6 months to 5 years with and without a history of atopic comorbidities [107] Results from the pivotal phase III LIBERTY AD PRESCHOOL trial showed that 46% of patients achieved 75% or greater improvement in overall disease severity. 14% of patients achieved clear or almost clear skin compared to 2% treated with placebo. Average reduction in overall disease severity from baseline was 55% and average reduction in itch was 42%. The previous results showed that the dupilumab treatment for 1 year provided sustained improvement in signs of atopic dermatitis in patients aged 6 months to 5 years with moderate-to-severe AD. Treatment of dupilumab in children aged 6 months to 5 years with moderate-to-severe atopic dermatitisb met its primary and all secondary endpoints and demonstrated that the dupilumab significantly reduced the signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months. More than seven times as many patients treated with Dupixent plus topical corticosteroids (TCS) achieved clear or almost clear skin compared to TCS alone at week 16 by reducing overall disease severity by 70% and itch by 49%. The primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75). The pre-specified primary analysis showed that at 16 weeks patients treated with Dupixent, 28% achieved clear or almost-clear skin compared to 4% with placebo (p=<0.0001). 53% achieved 75% or greater overall disease improvement from baseline compared to 11% with placebo (p=<0.0001). 70% average improvement from baseline in EASI compared to 20% improvement with placebo (p=<0.0001). 49% average improvement from baseline in itch compared to 2% improvement in placebo (p<0.0001). Significantly improved measures of observed patient outcomes (including sleep, skin pain and health-related quality of life), as well as caregiver-reported health-related quality of life [108] [71] [105] [104] .

The initial results from phase III trial in patients with atopic dermatitis (n=180, aged 6 months to 5 years) treated with dupilumab showed that mean (SD) eosinophil counts increased slightly from baseline (1.15 × 109/L [1.18]) to week 16 (1.5 × 109/L [1.91]), but then decreased below baseline by week 52 (0.80 × 109/L [0.64]). Mean (SD) platelet counts were relatively stable with a modest decrease from baseline (388.7 × 109/L [102.51]) to week 52 (356.1 × 109/L [107.48]). Chemistry parameters remained within the normal reference ranges [76] [380]

Phase II

Dupilumab, at all doses tested, was superior to placebo, in treatment of patients with moderate-to-severe atopic dermatitis in a phase IIb trial. The eczema area and severity index (EASI) scores improved from baseline by 74% and 45% for patients treated with dupilumab 300 mg/week and 100 mg/month, respectively, compared with 18% for patients in the placebo group (p<0.0001 for all doses). At week 16, the proportion of patients who experienced clearing or near clearing of skin, as assessed by an investigator's global assessment score of 0 or 1, was statistically significantly greater in the dupilumab group compared with the placebo group (12-33% vs 2%; p=0.02 to p<0.0001). Itching, as measured by the pruritus numerical-rating scale score, reduced by 16.5-47% in the dupilumab group, compared with a 5% increase in the placebo group (p=0.0005 to p<0.0001). Patients in the study were randomised to receive one of five doses of dupilumab 300 mg weekly, 300 mg every other week, 300 mg monthly, 200 mg every other week, 100 mg monthly, or placebo [115] .

In a phase IIa study of dupilumab in 109 patients with moderate-to-severe atopic dermatitis, 5.5% of patients showed skin infections with dupilmab treatment in comparison with 24.1% of patients receiving placebo (Regeneron, Form 10-K, February 2014).

Dupilumab is effective and persistent in the treatment of patients with moderate-to-severe atopic dermatitis, according to pooled data from two proof-of-concept trials in 67 patients from the US, Germany, Australia and New Zealand who received the agent subcutaneously once weekly for four weeks (NCT01385657 and NCT01259323). The data showed that dupilumab, compared with placebo, significantly improved scores for body surface area, investigator global assessment, and EASI at week 4 (p<0.05 vs placebo for all both 150mg and 300mg dosages) and that at week 8 these improvements were maintained in the 300mg group (p<0.05 vs placebo). In addition, at week 4, the proportion of patients with ≥50% reduction in EASI score was greater in the dupilumab 150mg and 300mg groups than in the placebo group (54.5% and 71.4% vs 18.8%; p<0.05) [123] .

Urticaria:

Phase III:

Dupixent did not reach statistical significance for the primary endpoints in an interim analysis despite numeric improvements observed across key endpoints in phase-III trial (CUPID STUDY B) in patients with chronic spontaneous urticaria (CSU) refractory to Omalizumab. Positive numerical trends were noticed in reducing itch and hives, However it was not significant. This study was performed on 83 patients with CSU between the age of 12 to 80 years [237] .

Phase III:

Updated results from phase III trial in patients with Chronic urticaria demonstrated that in comparison to placebo, a statistically higher percentage of patients treated with dupilumab had well-controlled urticaria (UAS <_6) or urticaria-free (UAS7 5 0) status. In a numerically greater proportion of patients achieving well-controlled urticaria (UAS7 <_6) from Week 8 and urticaria-free (UAS7 5 0) status from Week 14, vs placebo. At Week 24, 53.1% of dupilumab-treated patients achieved UAS7 <_6 and 35.9% achieved UAS7 5 0 (vs 34.0% and 18.9% with placebo; P 5 0.0379 and P 5 0.0411, respectively). Following discontinuation of dupilumab at Week 24, the proportion of patients achieving well-controlled [244] . The results from phase III CUPID (LIBERTY-CUPID) trial demonstrated that the, mean UAS7 and CU-Q2oL scores at baseline were 31.9/30.8 (dupilumab [n=70]/placebo [n=68]) and 41.0/46.7, respectively. UAS7 improved significantly in dupilumab-treated patients; at week 24, least squares (LS) mean change from baseline was −20.5/−12.0 for dupilumab/placebo, respectively (difference −8.5, P=0.0003). Similar results were seen in CU-Q2oL scores at Week 24; LS mean change from baseline was −29.6/−21.0 for dupilumab/placebo, respectively (difference −8.6; nominal P=0.0049) [366] . Results from the phase III CUPID (LIBERTY-CUPID) trial showed that, trial has met its primary endpoints and all key secondary endpoints at 24 weeks, showing duplimab nearly doubled reduction in itch and urticaria activity scores. Baseline characteristics were generally balanced across treatment groups. Mean ISS7 and UAS7 (dupilumab/placebo) at baseline were reported to be 16.1/15.7 and 31.9/30.8, respectively. At week 24, least squares (LS) mean change in ISS7 (range:0-21) from baseline was observed to be -10.2/-6.0 for dupilumab/placebo, respectively (LS mean difference-4.2, P = 0.0005) and for UAS7 (range:0-42) was observed to be -20.5/-12.0 (difference-8.5, P = 0.0003). Mean DLQI scores (dupilumab/placebo) at baseline were 13.5/15.3. DLQI scores improved signifcantly in dupilumab-treated patients; at Week 24, LS mean change from baseline was -10.8/-7.6 (difference -3.2; nominal P=0.0026) for dupilumab/placebo, respectively. Addition of duplimab to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone at 24 weeks. 63% reduction in itch severity with duplimab vs 35% with standard-of-care (antihistamines) as measured by a 0-21-point itch severity scale (10.24-point reduction with duplimab vs 6.01-point reduction with standard-of-care) (p<0.001), the primary endpoint in the US (secondary endpoint in the EU) with continuous improvement out to week 24. 65% reduction in urticaria activity (itch and hives) severity with duplimab vs 37% with standard-of-care, as measured by a 0-42-point urticaria activity scale, (20.53-point reduction with duplimab vs 12.00-point reduction with standard-of-care) (p<0.001) [242] [243] [239] [240] [241] .

In the phase III Liberty-AD-HAFT trial, treatment with dupilumab in adult and adolescent patients with moderate-to-severe atopic hand and foot dermatitis, met its primary and key secondary endpoints. Dupilumab significantly improved disease signs, symptoms and quality of life measures for this particularly difficult-to-treat subset of atopic dermatitis patients, with itch improvement seen as early as one week after the first dose. At 16 weeks, patients treated with dupilumab, 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo (p=0.01), the primary endpoint. 52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo (p<0.0001), the key secondary endpoint. An average 69% reduction in signs of hand and foot lesions from baseline compared to 31% with placebo (p<0.0001) were reported. Dupilumab showed 75% average improvement in hand eczema disease severity from baseline compared to 40% with placebo (p<0.0001). There were significant improvements in measures of hand and foot skin pain, sleep and hand eczema-related quality of life [61] [60] .

Pooled analysis:

Pooled data from the phase III PRIME and PRIME2 trials showed that significantly more patients treated with dupilumab vs placebo achieved within-patient meaningful improvement in WI-NRS (58.8% vs 19.0%; P<0.0001), Skin Pain-NRS (49.7% vs 20.9%; P<0.0001), and Sleep-NRS (42.5% vs 23.4%, P<0.0001) from baseline to Week 24 [343] . Previous results showed that skin pain-NRS was relevant, and the item wording and response scale were well understood. Skin Pain-NRS demonstrated good test-retest reliability (intraclass correlation coefficient >0.8 using Patient Global Impression of Severity [PGIS] and PGI-Change [PGIC]). Convergent and divergent validity was supported by moderate-to-strong correlations (absolute r=0.30-0.73) with related measures and weaker correlations (absolute r=0.01-0.28) with less-related measures, respectively. Significant differences (P<0.001) in Skin Pain-NRS scores between PGIS and PGIC groups confirmed the sensitivity of Skin Pain-NRS to changes in disease severity/clinical status. Anchor- and distribution-based analyses suggested a within-patient meaningful improvement threshold of 4-points (range:3.5–4.5) for Skin Pain NRS [344] [345] [346] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2025 Regulatory Status Sanofi and Regeneron to submit a regulatory application for pruritus in 2025 (Sanofi pipeline, May 2022) 05 May 2022
31 Dec 2025 Regulatory Status Regeneron and Sanofi plans to submit a regulatory application for Bullous pemphigoid, in 2025 (Sanofi pipeline, August 2022) [227] 03 Aug 2022
31 Dec 2025 Regulatory Status Sanofi and Regeneron plan to submit a regulatory application for Rhinosinusitis in 2025 (Sanofi pipeline, August 2022) 03 Aug 2022
31 Dec 2025 Regulatory Status Sanofi and Regenerone Pharmaceuticals plan to submit a regulatory application for Chronic urticaria in 2025 (Sanofi pipeline, February 2024) 19 Feb 2024
31 Dec 2024 Regulatory Status Sanofi and Regenerone announce intension to submit a regulatory application for Chronic obstructive pulmonary disease, in 2024 [227] 08 Mar 2024
31 Dec 2024 Regulatory Status Sanofi and Regenerone plans to submit a regulatory application for for Rhinosinusitis in 2024 (Sanofi pipeline, February 2022) 11 Feb 2022
31 Dec 2024 Regulatory Status Regeneron Pharmaceuticals anticipates EC decision on regulatory submission for dupixent for eosinophilic esophagitis in children (1–11 years of age) in second half of 2024 (9409255) 25 Feb 2024
31 Dec 2024 Regulatory Status Regeneron Pharmaceuticals anticipates FDA decision on sBLA in in COPD with type 2 inflammatory phenotype in second half of 2024 (9409255) 08 Feb 2024
31 Dec 2024 Trial Update Regeneron plans a phase I trial in severe food allergy following transient linvoseltamab treatment (in combination with Dupixent) in 2024 (9409255) 25 Feb 2024
27 Jun 2024 Regulatory Status FDA assigns PDUFA action date of (27/06/2024) for dupilumab for Chronic obstructive pulmonary disease [220] 27 Feb 2024
31 Mar 2024 Regulatory Status Regeneron Pharmaceuticals anticipates sBLA acceptance in COPD with type 2 inflammatory phenotype in Q1 of 2024 (9409255) 27 Feb 2024
31 Jan 2024 Regulatory Status FDA assigns PDUFA action date of (31/01/2024) for dupilumab for Eosinophilic oesophagitis (In children) in USA (SC) [262] 02 Feb 2024
31 Dec 2023 Regulatory Status Regeneron Pharmaceuticals anticipates a decision on the sBLA submission in Atopic dermatitis (In Infants, In children) in Japan in the second half of 2023 [45] 05 Jun 2023
31 Dec 2023 Regulatory Status Sanofi announces intention to submit regulatory application for Peanut hypersensitivity (In Children, Combination therapy) in 2023 14 Feb 2019
31 Dec 2023 Regulatory Status Regeneron announces intention to submit Supplemental BLA submission for Chronic obstructive pulmonary disease by end of 2023 [224] 08 Mar 2024
22 Oct 2023 Regulatory Status US FDA assigns target action date 22/10/2023 for sBLA of Dupilumab for Chronic urticaria [235] 10 Mar 2023
30 Jun 2023 Regulatory Status Regeneron Pharmaceuticals announces intention to submit additional sBLA for Eosinophilic oesophagitis in paediatric population by mid 2023 [45] 17 Nov 2023
31 Dec 2022 Regulatory Status Sanofi announces intention to submit regulatory applications to regulatory authorities for Eosinophilic oesophagitis in additional undisclosed countries, by the end of 2022 [263] 24 May 2022
31 Dec 2022 Regulatory Status Sanofi and Regeneron plan to submit additional regulatory applications around the world for Prurigo nodularis in 2022 (9359284) 30 Jun 2022
31 Dec 2022 Regulatory Status Regeneron announces intention to submit sBLA to the US FDA for Atopic dermatitis (In infants) in 2022 [22] 18 Mar 2022
30 Sep 2022 Regulatory Status The US FDA has given PDUFA for the decision of dupilumab in Prurigo nodularis by 30/09/2022 (9359284) 03 Nov 2022
03 Aug 2022 Regulatory Status The US FDA has given PDUFA for the sBLA for Dupilumab in Eosinophilic oesophagitis (In adolescents, In adults, In the elderly) by August 3rd, 2022 [264] 24 May 2022
30 Jun 2022 Regulatory Status Sanofi announces intention to submit regulatory application to the regulatory body for Atopic dermatitis (In children, In infants) in European Union in the first half of 2022 09 May 2022
30 Jun 2022 Regulatory Status Sanofi and Regenerone plans to submit a regulatory applications for Prurigo nodularis in the first half of 2022 (Sanofi pipeline, February 2022) (9285143) [347] 30 Jun 2022
31 Mar 2022 Regulatory Status Sanofi expects a decision from the European Medicines Agency (EMA) for dupilumab for uncontrolled severe Asthma (In children), in Q1 2022 [153] 14 Dec 2021
01 Jan 2022 Regulatory Status Sanofi announces intention to submit regulatory submission for Asthma (In children) in 2022 [371] 03 Aug 2018
01 Jan 2022 Regulatory Status Sanofi announces intention to submit regulatory submission for Eosinophilic oesophagitis in 2022 [371] 07 Apr 2022
31 Dec 2021 Regulatory Status Sanofi announces intention to submit regulatory application to the regulatory body for Atopic dermatitis (In children, In infants) in USA in 2021 14 Feb 2022
21 Oct 2021 Regulatory Status FDA assigns PDUFA action date of 21/10/2021 for dupilumab for Asthma (In children, Adjunctive treatment) [126] 25 Oct 2021
31 Aug 2021 Regulatory Status Sanofi announces intention to launch dupilumab as 200mg single-dose pre-filled pen for treatment of Atopic dermatitis, Asthma, Rhinosinusitis in August 2021 [9] 30 May 2023
31 Mar 2021 Regulatory Status Sanofi announces intention to submit regulatory application to the regulatory body for Asthma (In children, Adjunctive treatment) in USA, in Q1 2021 [156] 14 Oct 2020
31 Mar 2021 Regulatory Status Sanofi announces intention to submit regulatory application to the regulatory body for Asthma (In children, Adjunctive treatment) in European Union, in Q1 2021 [156] 05 Mar 2021
31 Jan 2021 Trial Update Sanofi plans a phase III trial for Chronic urticaria in late in 2020 or early 2021 [246] 13 Sep 2021
31 Jan 2021 Trial Update Sanofi plans a phase III trial for Sinusitis in late in 2020 or early 2021 [246] 28 Dec 2020
31 Jan 2021 Trial Update Sanofi plans a phase III trial for Rhinosinusitis in late in 2020 or early 2021 [246] 31 Dec 2020
12 Jan 2021 Trial Update Sanofi and Regeneron Pharmaceuticals plan a phase III trial for Atopic dermatitis (Treatment-experienced, In infants, In children, In adolescents) in Japan (SC, Injection), in January 2021 (NCT04678882) 26 Jan 2021
23 Nov 2020 Trial Update Regeneron Pharmaceuticals and Sanofi plans a phase III trial in Atopic dermatitis (In adolescents, In adults)(SC, Injection) in November 2020 (NCT04417894) (700322704) 21 Jan 2021
30 Sep 2020 Trial Update Regeneron Pharmaceuticals in collaboration with Sanofi plans a phase III trial in Allergic bronchopulmonary aspergillosis (Treatment-experienced) (SC) in September 2020 (NCT04442269) (EudraCT2019-002619-24) 14 Oct 2020
01 Sep 2020 Trial Update Regeneron Pharmaceuticals in a collaboration with Sanofi plans a phase III EoE KIDS trial in Eosinophilic oesophagitis (In children) (SC, Injection) in September 2020 (NCT04394351) (700322010) 23 Sep 2020
30 Jun 2020 Trial Update Regeneron and Sanofi plans a confirmatory phase III trial for Chronic obstructive pulmonary disease in the third quarter of 2020 [227] 16 Jun 2020
26 May 2020 Regulatory Status FDA assigns PDUFA action date of 26/05/2020 for dupilumab for Atopic dermatitis (Adjunctive treatment, In children) [50] 13 Feb 2020
31 Dec 2019 Trial Update Regeneron plans pivotal phase II/III trials for Chronic obstructive pulmonary disease in 2018 (700291335) [374] 13 Mar 2019
31 Dec 2019 Regulatory Status Regeneron announces intention to submit a Marketing Authorisation Application (MAA) to the EMA for Atopic dermatitis (In children) in by the end of 2019 [369] 13 Nov 2019
31 Dec 2019 Regulatory Status Regeneron announces intention to submit sBLA to the US FDA for Rhinosinusitis (In adults) in 2019 [374] 30 May 2023
31 Dec 2019 Trial Update Regeneron Pharmaceuticals plans a phase II/III (LIBERTY-BP) trial for Bullous Pemphigoid in December 2019 (700316329) (NCT04206553) 16 Jun 2020
31 Dec 2019 Regulatory Status Regeneron announces intention to submit sBLA to the US FDA for Atopic dermatitis (In children) in the fourth quarter of 2019 [67] 09 Aug 2019
30 Sep 2019 Regulatory Status Sanofi expects the EU regulatory decision for Atopic dermatitis (In adolescents) in the third quarter of 2019 [22] 12 Feb 2019
30 Jun 2019 Regulatory Status Sanofi expects the EU regulatory decision for Asthma (In adults, In adolescents) in the second quarter of 2019 [22] 12 Feb 2019
26 Jun 2019 Regulatory Status FDA assigns PDUFA action date of 26/06/2019 for Dupilumab for Rhinosinusitis (Adjunctive treatment) [303] 30 May 2023
31 Mar 2019 Regulatory Status Sanofi expects the US regulatory decision for Atopic dermatitis (In adolescents) in the first quarter of 2019 [22] 12 Feb 2019
11 Mar 2019 Regulatory Status FDA assigns PDUFA action date of (11/03/2019) for dupilumab for Atopic dermatitis (Monotherapy, In children, In adolescents) [31] 13 Nov 2018
01 Jan 2019 Trial Update Sanofi plans a phase III trial for Asthma in January 2019 (NCT03782532) (700302955) 04 Apr 2019
31 Dec 2018 Trial Update Regeneron plans a phase II trial for Grass pollen hypersensitivity (Adjunctive treatment) in 2018 (SC) (700291355) (NCT03558997) [374] 03 Jul 2018
31 Dec 2018 Regulatory Status Sanofi expects US FDA regulatory decision in Asthma (In Adult, In adolescent patients) in Q4 of 2018 [371] 04 Apr 2019
31 Dec 2018 Trial Update Sanofi-aventis plans a long term phase III safety trial for Asthma in France, Argentina, Belgium, Canada, France, Germany, Israel, Japan, Netherlands, South Africa and USA (EudraCT2017-002134-23) (700298336) 10 Jul 2019
31 Dec 2018 Trial Update Regeneron plans clinical trials for Inflammation (comorbid allergic inflammatory conditions) in 2018 [374] 19 Dec 2017
31 Dec 2018 Regulatory Status The Scottish Medicines Consortium (SMC) is expected to provide recommendation for dupilumab for Atopic dermatitis in Scotland in the fourth quarter of 2018 [372] 26 Jun 2018
01 Dec 2018 Regulatory Status Regeneron announces intention to submit MAA to the EMA for Atopic dermatitis (In adolescents) in 2018 [370] 17 Nov 2018
08 Nov 2018 Trial Update Regeneron plans a phase III trial for Eosinophilic oesophagitis (NCT03633617) (700291354) [374] 19 Nov 2018
20 Oct 2018 Regulatory Status FDA assigns PDUFA action date of 20/10/2018 for dupilumab for Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) [139] 23 Oct 2018
30 Sep 2018 Regulatory Status Sanofi and Regeneron announce intention to submit sBLA to the US FDA for Atopic dermatitis (In adolescents) in the third quarter of 2018 [100] 04 Apr 2019
01 Aug 2018 Regulatory Status The National Institute for Health and Care Excellence (NICE) is expected to provide final Technology Appraisal Guidance (TAG) for dupilumab for Atopic dermatitis in England on 1 August 2018 [372] 26 Jun 2018
31 Jul 2018 Trial Update Sanofi-aventis plans the Liberty Asthma Excursion phase III trial for Asthma in Argentina, Australia, Brazil, Canada, Chile, Colombia, Hungary, Italy, Lithuania, Mexico, Poland, Romania, Russia, South Africa, Spain, Turkey, Ukraine, USA (700295501), (EudraCT2017-003317-25 ) 27 Jun 2018
30 Jun 2018 Regulatory Status Sanofi announces intention to submit marketing authorisation application in European Union for Asthma (In adolescents, In adults) in second quarter of 2018 [373] 09 Feb 2018
01 May 2018 Regulatory Status Regeneron Pharmaceuticals and Sanofi intend to launch dupilumab for Atopic dermatitis in Germany by the end of 2017 [375] 04 Apr 2018
31 Dec 2017 Regulatory Status Regeneron Pharmaceuticals announces intention to submit a sBLA to US FDA for Asthma (In adolescents, In adults) (uncontrolled asthma) by the end of 2017 [376] 24 Jan 2018
31 Dec 2017 Trial Update Regeneron Pharmaceuticals plans a phase III trial for Atopic dermatitis (In children, Combination therapy) in December 2017 in USA (SC) (NCT03345914) (700275478) [376] 21 Dec 2017
30 Apr 2017 Trial Update Regeneron Pharmaceuticals and Sanofi plans a phase I trial for Allergic asthma (Monotherapy, Combination therapy) (NCT03112577) 22 May 2017

Development History

Event Date Update Type Comment
03 Apr 2024 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In children) in Norway (SC) Updated 03 Apr 2024
03 Apr 2024 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In adolescents) in Norway (SC) Updated 03 Apr 2024
03 Apr 2024 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In children) in United Kingdom (SC) Updated 03 Apr 2024
03 Apr 2024 Phase Change - Marketed Launched for Atopic dermatitis (In children, In infants) in Japan (SC) Updated 03 Apr 2024
03 Apr 2024 Phase Change - Marketed Launched for Prurigo nodularis (In adults) in Japan, Norway (SC) Updated 03 Apr 2024
03 Apr 2024 Phase Change - Marketed Launched for Rhinosinusitis (Adjunctive treatment, In adults) in Japan (SC) Updated 03 Apr 2024
03 Apr 2024 Phase Change - Marketed Launched for Rhinosinusitis (Adjunctive treatment, In adults) in Norway (SC) Updated 03 Apr 2024
05 Mar 2024 Trial Update Regeneron and Sanofi plan a phase III trial in Prurigo nodularis (In infants, In children, In adolescents) (SC) in February 2024 (NCT06293053) Updated 11 Mar 2024
04 Mar 2024 Phase Change - Discontinued(II) Discontinued - Phase-II for Rhinosinusitis (Treatment-experienced) in Spain, Russia, Portugal, South Korea, Hungary, China, Chile, Belgium, Argentina, United Kingdom, Sweden (SC) [233] Updated 04 Mar 2024
23 Feb 2024 Scientific Update Efficacy data from phase II/III ENGAGE trial in Eosinophilic gastroenteritis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAI-2024) [258] Updated 04 Apr 2024
23 Feb 2024 Scientific Update Efficacy and adverse event data from phase III open-label extension trial in Atopic dermatitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024) [93] Updated 01 Apr 2024
23 Feb 2024 Scientific Update Updated efficacy and adverse event data from the phase III EOE KIDS trial in Eosinophilic esophagitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024) [274] [275] Updated 01 Apr 2024
23 Feb 2024 Scientific Update Updated efficacy data from a phase III trial in Chronic urticaria presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2024) [244] Updated 01 Apr 2024
23 Feb 2024 Scientific Update Updated efficacy data from a phase III CHRONOS trial in Atopic dermatitis presented at the 2024 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAI-2024) [87] Updated 01 Apr 2024
23 Feb 2024 Phase Change - Marketed Launched for Eosinophilic oesophagitis (In adolescents, In adults) in Canada (SC) Updated 27 Feb 2024
23 Feb 2024 Regulatory Status Dupilumab receives priority review status for Chronic obstructive pulmonary disease in the USA [220] Updated 27 Feb 2024
23 Feb 2024 Regulatory Status FDA assigns PDUFA action date of (27/06/2024) for dupilumab for Chronic obstructive pulmonary disease [220] Updated 27 Feb 2024
23 Feb 2024 Regulatory Status The US FDA accepts sBLA for dupilumab for Chronic obstructive pulmonary disease [220] Updated 27 Feb 2024
19 Feb 2024 Regulatory Status Sanofi and Regenerone Pharmaceuticals plan to submit a regulatory application for Chronic urticaria in 2025 (Sanofi pipeline, February 2024) Updated 19 Feb 2024
16 Feb 2024 Phase Change - Marketed Launched for Chronic-urticaria (In children, In adolescents, In the elderly, Treatment-experienced, In adults) in Japan (SC) [231] Updated 23 Feb 2024
16 Feb 2024 Phase Change - Registered Registered for Chronic-urticaria (Treatment-experienced, In adults, In adolescents, In children, In the elderly) in Japan (SC) [232] Updated 21 Feb 2024
09 Feb 2024 Trial Update Regeneron Pharmaceuticals in collaboration with Sanofi completes a phase II LIBERTY ABPA AIRED trial in Aspergillosis in USA, Bulgaria, France, Germany, Hungary, Japan, Netherlands, Poland, Romania and the UK (SC) (NCT04442269) (EudraCT2019-002619-24) Updated 15 Mar 2024
08 Feb 2024 Regulatory Status Regeneron Pharmaceuticals anticipates sBLA acceptance in COPD with type 2 inflammatory phenotype in Q1 of 2024 [221] Updated 27 Feb 2024
06 Feb 2024 Phase Change - Marketed Launched for Eosinophilic oesophagitis (In children, In infants) in USA (SC) [261] Updated 06 Feb 2024
02 Feb 2024 Regulatory Status Regeneron Pharmaceuticals anticipates EC decision on regulatory submission for dupixent for eosinophilic esophagitis in children (1–11 years of age) in second half of 2024 [221] Updated 25 Feb 2024
02 Feb 2024 Trial Update Regeneron plans a phase I trial in severe food allergy following transient linvoseltamab treatment (in combination with Dupixent) in 2024 [221] Updated 25 Feb 2024
02 Feb 2024 Regulatory Status Regeneron Pharmaceuticals anticipates FDA decision on sBLA in in COPD with type 2 inflammatory phenotype in second half of 2024 [221] Updated 08 Feb 2024
01 Feb 2024 Phase Change - Preregistration Preregistration for Chronic obstructive pulmonary disease in China (SC) [222] Updated 07 Feb 2024
01 Feb 2024 Phase Change - Preregistration Preregistration for Chronic obstructive pulmonary disease in USA (SC) [222] Updated 07 Feb 2024
29 Jan 2024 Trial Update Sanofi completes the phase II Liberty CRSsNP trial in Rhinosinusitis (Treatment-experienced) in Canada, Sweden, United Kingdom, Argentina, Belgium, Chile, China, Hungary, South Korea, Portugal, Russia, Spain (SC) (NCT04678856) Updated 27 Feb 2024
25 Jan 2024 Phase Change - Registered Registered for Eosinophilic oesophagitis (In children, In Infants) in USA (SC) [261] Updated 01 Feb 2024
25 Jan 2024 Scientific Update Updated efficacy and adverse events data from a phase III EOE KIDS trial in Eosinophilic oesophagitis released by Regeneron [261] Updated 01 Feb 2024
03 Jan 2024 Phase Change - III Phase-III clinical trials in Asthma (Treatment-experienced, In children) in Canada, USA, Argentina (SC) (NCT06191315) Updated 23 Feb 2024
03 Jan 2024 Phase Change - III Phase-III clinical trials in Wheezing (In children, Treatment-experienced) in USA, Argentina, Canada (SC) (NCT06191315) Updated 23 Feb 2024
03 Jan 2024 Trial Update Sanofi plans a phase III LIBERTY ASTHMA TREKIDS trial for Asthma and wheezing (In children, Treatment-experienced) (SC, injection) (NCT06191315) Updated 09 Jan 2024
27 Nov 2023 Regulatory Status Regeneron announces intention to submit Supplemental BLA submission for Chronic obstructive pulmonary disease by end of 2023 [224] Updated 08 Mar 2024
27 Nov 2023 Phase Change - Preregistration Preregistration for Chronic obstructive pulmonary disease in European Union (SC) [224] Updated 29 Nov 2023
27 Nov 2023 Scientific Update Efficacy and adverse events data from the phase III NOTUS trial in Chronic obstructive pulmonary disease released by Regeneron [224] Updated 29 Nov 2023
09 Nov 2023 Scientific Update Efficacy data from the phase II/III Liberty AD PRESCHOOL trial in Atopic dermatitis presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (AAAAI-2023) [109] Updated 22 Feb 2024
09 Nov 2023 Scientific Update Efficacy data from the phase III ASTHMA VENTURE trial in Asthma presented at the 023 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2023) [208] [209] Updated 22 Feb 2024
09 Nov 2023 Scientific Update Interim efficacy data from a phase III trial in Atopic dermatitis presented at the 2023 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI - 2023) [92] Updated 22 Feb 2024
05 Nov 2023 Financial Update Credit Suisse financial data update Updated 05 Nov 2023
28 Oct 2023 Trial Update Sanofi in collaboration with Regeneron Pharmaceuticals completes a phase III trial in Atopic dermatitis (Treatment-experienced, In infants, In children, In adolescents) in Japan (SC) (NCT04678882) (EudraCT2020-002601-26) Updated 26 Dec 2023
23 Oct 2023 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Treatment-experienced) in USA (SC) (NCT05545072) Updated 23 Oct 2023
22 Oct 2023 Scientific Update Efficacy and adverse events data from a phase III trial in Eosinophilic Esophagitis released by Regeneron [273] Updated 24 Oct 2023
20 Oct 2023 Regulatory Status The US FDA issues a Complete Response Letter regarding the sBLA of Dupilumab for the treatment of Chronic spontaneous urticaria [234] Updated 24 Oct 2023
14 Oct 2023 Scientific Update Efficacy and adverse event data from the phase III LIBERTY EoE TREET trial in Eosinophilic oesophagitis presented at the 31st United European Gastroenterology Week (UEGW-2023) [291] Updated 29 Nov 2023
14 Oct 2023 Scientific Update Efficacy data from the phase III LIBERTY-EoE-TREET trial in Eosinophilic oesophagitis presented at the 31st United European Gastroenterology Week (UEGW-2023) [290] Updated 29 Nov 2023
03 Oct 2023 Trial Update Regeneron Pharmaceuticals in collaboration with Sanofi resumes enrolment in the expanded access program for Bullous-pemphigoid (SC) (NCT05906706) Updated 18 Oct 2023
30 Sep 2023 Phase Change - Registered Registered for Atopic dermatitis (In children, In infants) in Japan (SC) [48] Updated 09 Nov 2023
26 Sep 2023 Regulatory Status FDA assigns PDUFA action date of (31/01/2024) for dupilumab for Eosinophilic oesophagitis (In children) in USA (SC) [262] Updated 02 Feb 2024
26 Sep 2023 Regulatory Status The US FDA accepts for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab for Eosinophilic esophagitis (In children) [262] Updated 28 Sep 2023
25 Sep 2023 Phase Change - Preregistration Preregistration for Eosinophilic oesophagitis (In children) in USA (SC) before September 2023 [262] Updated 29 Sep 2023
09 Sep 2023 Scientific Update Updated efficacy data from a phase III EXCURSION trial in Asthma presented at the 33rd Annual Congress of the European Respiratory Society (ERS-2023) [152] Updated 20 Nov 2023
09 Sep 2023 Scientific Update Efficacy and adverse event data from a phase III trial in Asthma presented at the 33rd Annual Congress of the European Respiratory Society (ERS-2023) [145] Updated 10 Nov 2023
07 Aug 2023 Regulatory Status Dupilumab - Regeneron/Sanofi receives Breakthrough Therapy status for Chronic obstructive pulmonary disease in USA, prior to August 2023 [223] Updated 07 Aug 2023
07 Aug 2023 Regulatory Status Regeneron Pharmaceuticals plans to submit sBLA to US FDA for Chronic obstructive pulmonary disease [223] Updated 07 Aug 2023
08 Jul 2023 Scientific Update Efficacy and adverse event data from a phase III trial in Asthma presented at the 119th International Conference of the American Thoracic Society (ATS-2023) [144] Updated 08 Jul 2023
30 Jun 2023 Phase Change - Registered Registered for Prurigo nodularis (In adults) in Japan (SC) [223] Updated 12 Oct 2023
08 Jun 2023 Trial Update Sanofi initiates a phase I trial in volunteers in USA (SC) (NCT05976386) Updated 09 Aug 2023
07 Jun 2023 Trial Update Regeneron Pharmaceuticals collaborator Sanofi temporarily suspends an expanded access program of dupilumab in Bullous pemphigoid (NCT05906706) Updated 21 Jun 2023
05 Jun 2023 Regulatory Status Regeneron Pharmaceuticals announces intention to submit additional sBLA for Eosinophilic oesophagitis in paediatric population by mid 2023 [45] Updated 17 Nov 2023
05 Jun 2023 Regulatory Status Regeneron Pharmaceuticals anticipates a decision on the sBLA submission in Atopic dermatitis (In Infants, In children) in Japan in the second half of 2023 [45] Updated 05 Jun 2023
30 May 2023 Trial Update Sanofi completes the phase III BOREAS trial in Chronic obstructive pulmonary disease in the US, Argentina, Canada, Chile, China, Czechia, Denmark, Finland, Germany, Hungary, Israel, Italy, Japan, South Korea, Mexico, Poland, Romania, Russia, Slovakia, Spain, Swede Turkey, Ukraine (SC, Injection) (NCT03930732) (EudraCT2018-001953-28) Updated 30 May 2023
21 May 2023 Scientific Update Efficacy data from a phase III BOREAS trial in Chronic obstructive pulmonary disease released by Regeneron [228] Updated 25 May 2023
19 May 2023 Scientific Update Efficacy and adverse events data from the phase III BOREAS trial in Chronic obstructive pulmonary disease presented at the 119th International Conference of the American Thoracic Society (ATS-2023) [230] Updated 11 Jul 2023
19 May 2023 Scientific Update Efficacy data from a phase III LIBERTY ASTHMA VOYAGE trial in Asthma presented at the 119th International Conference of the American Thoracic Society (ATS-2023) [167] Updated 11 Jul 2023
19 May 2023 Scientific Update Updated efficacy data from a phase III EXCURSION trial in Asthma presented at the 119th International Conference of the American Thoracic Society (ATS-2023) [151] Updated 11 Jul 2023
19 May 2023 Scientific Update Efficacy and adverse event data from a phase III trial in Asthma presented at the 119th International Conference of the American Thoracic Society (ATS-2023) [196] [197] Updated 08 Jul 2023
19 May 2023 Scientific Update Updated pooled efficacy data from the phase III LIBERTY ASTHMA QUEST and LIBERTY ASTHMA TRAVERSE trial in Asthma presented at the 119th International Conference of the American Thoracic Society (ATS-2023) [169] Updated 08 Jul 2023
17 May 2023 Trial Update Sanofi completes enrolment in the phase-II DUPSHE clinical trials in Eczema (Treatment-experienced) in Netherlands (SC) prior to May 2023 [294] Updated 07 Jun 2023
16 May 2023 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in China (SC) (NCT05878093) Updated 31 May 2023
09 May 2023 Scientific Update Efficacy and safety data from a phase III trial in Atopic dermatitis presented at the American Academy of Dermatology annual Meeting 2023 (AAD-2023) [76] Updated 17 May 2023
06 May 2023 Scientific Update Efficacy data from phase-III LIBERTY-EoE-TREET trial in Eosinophilic oesophagitis presented at the Digestive Disease Week (DDW-2023) [287] Updated 23 Jun 2023
06 May 2023 Scientific Update Efficacy data from the phase III LIBERTY-EoE-TREET trial in Eosinophilic oesophagitis presented at the Digestive Disease Week (DDW-2023) [288] [289] Updated 23 Jun 2023
04 May 2023 Phase Change - Registered Registered for Eosinophilic oesophagitis (In adolescents, In adults) in Canada (SC) [266] Updated 08 May 2023
04 May 2023 Active Status Review 9387713 - No update, EU approval and Endpoint met info already covered Updated 04 May 2023
03 May 2023 Phase Change - II/III Phase-II/III clinical trials in Eosinophilic gastroenteritis (In children, In adolescents, In adults, In the elderly) in Italy (SC) (NCT05831176) Updated 04 Apr 2024
03 May 2023 Phase Change - II/III Phase-II/III clinical trials in Eosinophilic gastroenteritis (In adolescents, In children, In the elderly, In adults) in Poland, Australia (SC) (NCT05831176) Updated 22 Feb 2024
28 Apr 2023 Phase Change - II/III Phase-II/III clinical trials in Eosinophilic gastroenteritis (In adolescents, In children, In the elderly, In adults) (SC) in USA(NCT05831176) [1] Updated 09 May 2023
28 Apr 2023 Trial Update Regeneron Pharmaceuticals in collaboration with Sanofi plans the phase II/III ENGAGE trial in Eosinophilic gastritis (In adolescents, In adults, In the elderly) (SC) in April 2023 (NCT05831176) [233] Updated 02 May 2023
27 Apr 2023 Phase Change - Discontinued(II/III) Discontinued - Phase-II/III for Rhinosinusitis (In adolescents, In adults) in Canada (SC) before April 2023 due to portfolio prioritization [233] Updated 02 May 2023
27 Apr 2023 Phase Change - Discontinued(III) Discontinued - Phase-III for Rhinosinusitis (In adolescents, In adults) in USA (SC) before April 2023 due to portfolio prioritization [233] Updated 02 May 2023
27 Apr 2023 Phase Change - Preregistration Preregistration for Chronic-urticaria (In adolescents, In children, In the elderly, Treatment-experienced, In adults) in Japan (SC) before April 2023 [233] Updated 02 May 2023
20 Apr 2023 Trial Update Sanofi and Regeneron Pharmaceuticals completes the phase III LIBERTY-CINDU CUrIADS trial in Chronic urticaria (In adolescents, In adults, In children, In the elderly, Treatment-experienced) in USA, Argentina, Canada, Germany and Japan (NCT04681729) (EudraCT2020-003756-33) Updated 16 May 2023
20 Apr 2023 Phase Change - Marketed Launched for Atopic dermatitis (In children, In infants, Treatment-experienced) in Canada (SC) [10] Updated 25 Apr 2023
20 Apr 2023 Phase Change - Registered Registered for Atopic dermatitis (In children, In infants, Treatment-experienced) in Canada (SC) [10] Updated 25 Apr 2023
17 Apr 2023 Regulatory Status 3773651- No update Updated 17 Apr 2023
12 Apr 2023 Scientific Update Efficacy data from a phase III LIBERTY-CSU CUPID trial in Chronic-urticaria presented at the American Academy of Allergy, Asthma and Immunology annual meeting 2023 (AAAAI-2023) [243] Updated 19 Apr 2023
23 Mar 2023 Scientific Update Efficacy and adverse events data from a phase III BOREAS trial in Chronic obstructive pulmonary disease released by Regeneron [229] Updated 27 Mar 2023
22 Mar 2023 Scientific Update Updated efficacy data from a phase IIIin atopic dermatitis released by Regeneron Pharmaceuticals [108] Updated 23 Mar 2023
21 Mar 2023 Phase Change - Registered Registered for Atopic dermatitis (In children, In infants, Treatment-experienced) in European Union (SC) [11] Updated 22 Mar 2023
18 Mar 2023 Scientific Update Efficacy and adverse event data from the phase III Liberty-AD-HAFT trial in Atopic dermatitis released by Regeneron Pharmaceuticals [61] Updated 21 Mar 2023
17 Mar 2023 Scientific Update Efficacy and adverse events data from a phase III LIBERTY AD PRESCHOOL trial in Atopic dermatitis presented at the American Academy of Dermatology annual Meeting 2023 (AAD-2023) [62] Updated 18 May 2023
17 Mar 2023 Scientific Update Updated efficacy data from a phase III CUPID (LIBERTY-CUPID) trial in Chronic urticaria presented at the American Academy of Dermatology annual Meeting 2023 (AAD-023) [366] Updated 18 May 2023
17 Mar 2023 Scientific Update Interim adverse events data from a phase III LIBERTY AD PED-OLE trial in Atopic dermatitis presented at the American Academy of Dermatology annual Meeting 2023 (AAD-2023) [75] Updated 17 May 2023
17 Mar 2023 Scientific Update Pooled analysis efficacy data from the phase III PRIME and PRIME2 trials in Prurigo nodularis presented at the American Academy of Dermatology annual Meeting 2023 (AAD-2023) [344] [343] Updated 17 May 2023
07 Mar 2023 Phase Change - Preregistration Preregistration for Chronic-urticaria (In children, In the elderly, Treatment-experienced, In adolescents, In adults) in USA (SC) [235] Updated 10 Mar 2023
07 Mar 2023 Regulatory Status US FDA assigns target action date 22/10/2023 for sBLA of Dupilumab for Chronic urticaria [235] Updated 10 Mar 2023
07 Mar 2023 Regulatory Status US FDA accepts sBLA for Dupilumab for Chronic urticaria (Treatment-experienced, In children, In adults, In adolescents, In the elderly) [235] Updated 10 Mar 2023
28 Feb 2023 Trial Update Charite University in collaboration with Sanofi and Proinnovera GmBH completes a phase II trial for Urticaria in Germany (SC) (NCT03749148) Updated 18 Sep 2023
24 Feb 2023 Scientific Update Updated efficacy data from the LIBERTY EoE TREET phase III trial in Eosinophilic esophagitis presented at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (ACAAI-2023) [286] Updated 26 Apr 2023
24 Feb 2023 Scientific Update Updated efficacy and adverse event data from a phase III Liberty Asthma Excursion trial in Asthma presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2023) [150] Updated 25 Apr 2023
24 Feb 2023 Scientific Update Pooled pharmacodynamics data from phase III LIBERTY AD PEDS, LIBERTY AD PRESCHOOL and LIBERTY AD ADOL trials in Atopic dermatitis presented at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2023) [64] Updated 24 Apr 2023
24 Feb 2023 Scientific Update Efficacy data from a phase II/III LIBERTYAD PRESCHOOL trial in Atopic dermatitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2023) [107] Updated 21 Apr 2023
24 Feb 2023 Scientific Update Efficacy data from a phase III trial in Asthma presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (AAAAI-2023) [195] Updated 17 Apr 2023
06 Feb 2023 Patent Information Regeneron Pharmaceuticals has patent protection for formulations and methods of treatment for dupilumab in USA [45] Updated 05 Jun 2023
06 Feb 2023 Patent Information Regeneron Pharmaceuticals has patent protection for methods of treatment for dupilumab in Europe and Japan [45] Updated 05 Jun 2023
06 Feb 2023 Phase Change - Marketed Launched for Atopic dermatitis (In adolescents) in Japan (SC) as of February 2023 [45] Updated 05 Jun 2023
06 Feb 2023 Phase Change - Preregistration Preregistration for Atopic dermatitis (In infants, In children) in Japan (SC) Updated 05 Jun 2023
06 Feb 2023 Phase Change - Registered Registered for Atopic dermatitis (In adolescents) in Japan (SC) as of February 2023 [45] Updated 05 Jun 2023
06 Feb 2023 Trial Update Regeneron Pharmaceuticals initiates a phase III trial for Atopic dermatitis in an Unknown location as of February 2023 [45] Updated 05 Jun 2023
31 Jan 2023 Phase Change - Marketed Launched for Eosinophilic oesophagitis (In adolescents, In adults) in Austria, Denmark, Sweden, France, Spain, Netherlands, Germany, Hungary, Czech Republic, Poland, Ireland (SC) [265] Updated 05 Apr 2023
30 Jan 2023 Phase Change - Registered Registered for Eosinophilic oesophagitis (In adolescents, In adults) in European Union (SC) [265] Updated 31 Jan 2023
27 Jan 2023 Regulatory Status The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion for Dupilumab in Atopic dermatitis in children 6 months to 5 years old [13] Updated 30 Jan 2023
12 Jan 2023 Phase Change - II Phase-II clinical trials in Ulcerative colitis (Treatment-experienced) in South Korea, Japan (SC) (NCT05731128) Updated 02 May 2023
12 Jan 2023 Phase Change - II Phase-II clinical trials in Ulcerative colitis (Treatment-experienced) in USA (SC) (NCT05731128) Updated 21 Feb 2023
31 Dec 2022 Patent Information Sanofi has patent protection in USA, EU and Japan, prior to December 2022 [360] Updated 04 Apr 2023
31 Dec 2022 Patent Information Sanofi has pending patent applications in USA, EU and Japan, prior to December 2022 [360] Updated 04 Apr 2023
21 Dec 2022 Scientific Update Updated efficacy and safety data from a phase III trial in Eosinophilic oesophagitis released by Regeneron Pharmaceuticals [367] Updated 23 Dec 2022
16 Dec 2022 Regulatory Status Committee for Medicinal Products for Human Use (CHMP) recommends positive opinion of dupilumab for eosinophilic esophagitis (EoE) in European Union [267] Updated 20 Dec 2022
14 Dec 2022 Phase Change - Registered Registered for Prurigo nodularis (In adults) in European Union, Iceland, Liechtenstein, Liechtenstein, Norway (SC) [337] [336] Updated 16 Dec 2022
23 Nov 2022 Trial Update Regeneron Pharmaceuticals and Sanofi completes the phase III Liberty-AD-HAFT in Atopic dermatitis (In adolescents, In adults) in USA, Germany, Japan and Poland (SC) (NCT04417894) Updated 26 Jan 2023
11 Nov 2022 Regulatory Status EMA CHMP issues a positive opinion recommending approval of dupilumab in moderate-to-severe Prurigo nodularis [340] Updated 15 Nov 2022
10 Nov 2022 Scientific Update Pharmacodynamics data from a phase III trial in indication) presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACCAI-2022) [194] Updated 04 Jan 2023
10 Nov 2022 Scientific Update Updated adverse event data from phase III open-label extension trial in Atopic dermatitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [91] Updated 04 Jan 2023
10 Nov 2022 Scientific Update Updated efficacy and adverse event data from a phase III (Liberty Asthma Excursion) trial in Asthma presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2022) [149] Updated 04 Jan 2023
10 Nov 2022 Trial Update Efficacy and adverse events data from phase III LIBERTY-EoE-TREET trial in Eosinophilic oesophagitis presented at 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2022) [285] Updated 04 Jan 2023
28 Oct 2022 Phase Change - Marketed Launched for Atopic dermatitis (In adults) in China (SC) [19] Updated 03 Nov 2022
28 Oct 2022 Phase Change - Marketed Launched for Eosinophilic oesophagitis (In adolescents, In the elderly, In adults) in USA (SC) prior to October 2022 [19] Updated 03 Nov 2022
12 Oct 2022 Trial Update Sanofi and McMaster University completes a phase III trial in Asthma (In adults, In the elderly) in Canada (SC, Injection) (NCT03884842) Updated 01 Feb 2023
11 Oct 2022 Scientific Update Updated efficacy and safety data from a phase III trial in Eosinophilic esophagitis presented at the United European Gastroenterology Week (UEGW-2022) [269] [270] Updated 13 Oct 2022
28 Sep 2022 Scientific Update Pooled analysis adverse events data from phase III PRIME and PRIME2 trials in prurigo nodularis released by Regeneron Pharmaceuticals [338] Updated 01 Nov 2022
28 Sep 2022 Phase Change - Marketed Launched for Prurigo nodularis (Treatment-experienced) in USA (SC) [338] Updated 04 Oct 2022
28 Sep 2022 Phase Change - Registered Registered for Prurigo nodularis (Treatment-experienced) in USA (SC) [338] Updated 04 Oct 2022
15 Sep 2022 Scientific Update Efficacy and safety data from the phase III LIBERTY AD PRESCHOOL trial in Atopic dermatitis released by Regeneron Pharmaceuticals [106] Updated 27 Sep 2022
06 Sep 2022 Scientific Update Efficacy data from a phase III LIBERTY ASTHMA EXCURSION trial in Asthma released by Regeneron Pharmaceuticals [148] Updated 09 Sep 2022
05 Sep 2022 Scientific Update Adverse events data from a phase III Liberty Asthma Excursion trial in Asthma released by Regeneron Pharmaceuticals [147] Updated 07 Sep 2022
04 Sep 2022 Scientific Update Updated efficacy and adverse events data from a phase III trial in Asthma presented at the 32nd annual congress of the european respiratory society (ERS-2022) [184] Updated 13 Feb 2023
04 Sep 2022 Scientific Update Efficacy data from a phase III trial in Rhinosinusitis presented at the 32nd Annual Congress of the European Respiratory Society(ERS- 2022) [325] Updated 07 Feb 2023
04 Sep 2022 Scientific Update Updated efficacy data from a phase III LIBERTY ASTHMA VOYAGE trial in Asthama presented at the 32nd Annual Congress of the European Respiratory Society (ERS-2022) [164] [165] Updated 07 Feb 2023
04 Sep 2022 Scientific Update Efficacy data from a phase III LIBERTY ASTHMA QUEST and LIBERTY ASTHMA TRAVERSE trial in Asthma presented at the 32nd Annual Congress of the European Respiratory Society (ERS-2022) [168] Updated 06 Feb 2023
04 Sep 2022 Scientific Update Efficacy and adverse events data from a phase III trial in Asthma presented at the 32nd Annual Congress of the European Respiratory Society 2022 (ERS-2022) [193] Updated 03 Feb 2023
25 Aug 2022 Phase Change - III Phase-III clinical trials in Chronic-urticaria (In children) in Japan, Canada (SC) (NCT05526521) Updated 13 Feb 2024
25 Aug 2022 Trial Update Sanofi initiates enrolment in a phase III trial for Chronic Urticaria in USA (NCT05526521) Updated 09 Sep 2022
25 Aug 2022 Phase Change - III Phase-III clinical trials in Chronic-urticaria (In children) in USA (SC) (NCT05526521) Updated 06 Sep 2022
10 Aug 2022 Scientific Update Updated efficacy and safety data from a phase III trial in Eosinophilic oesophagitis presented at the United European Gastroenterology Week (UEGW-2022) [276] Updated 24 Nov 2022
03 Aug 2022 Phase Change - Preregistration Preregistration for Prurigo nodularis in European Union (SC) prior to August 2022 [341] Updated 12 Sep 2022
03 Aug 2022 Phase Change - Preregistration Preregistration for Prurigo nodularis in Japan (SC) prior to August 2022 [341] Updated 12 Sep 2022
28 Jul 2022 Phase Change - Discontinued(II) Discontinued - Phase-II for Peanut hypersensitivity (In adolescents, In children) in Canada, USA (SC) [2] Updated 29 Jul 2022
14 Jul 2022 Scientific Update Efficacy and adverse events data from a phase III trial in Eosinophilic Esophagitis released by Regeneron [272] Updated 17 Jul 2022
13 Jul 2022 Trial Update Revelation Biosciences completes a phase III trial in Eosinophilic oesophagitis (In adolescents, In adults) in Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom and USA (SC) (NCT03633617) Updated 28 Jul 2022
08 Jul 2022 Regulatory Status The US FDA has given PDUFA for the decision of dupilumab in Prurigo nodularis by 30/09/2022 [339] Updated 03 Nov 2022
30 Jun 2022 Regulatory Status Sanofi and Regeneron plan to submit additional regulatory applications around the world for Prurigo nodularis in 2022 [339] Updated 30 Jun 2022
27 Jun 2022 Trial Update Regeneron & Sanofi completes a phase III LIBERTY AD OLE extension trial for Atopic dermatitis in Australia, Austria, Belgium, Bulgaria, Canada, China, Czech republic, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Japan, South Korea, Lithuania, Netherlands, New Zealand, Poland, Romania, Russia, Singapore, Slovakia, Spain, United Kingdom and USA (NCT01949311) (EudraCT2013-001449-15) Updated 07 Oct 2022
07 Jun 2022 Phase Change - Marketed Launched for Atopic dermatitis (In children, In infants, Treatment-experienced) in USA (SC) [14] Updated 14 Jun 2022
07 Jun 2022 Phase Change - Registered Registered for Atopic dermatitis (In children, In infants, Treatment-experienced) in USA (SC) [14] Updated 09 Jun 2022
30 May 2022 Phase Change - Preregistration Preregistration for Prurigo nodularis (Treatment-experienced) in USA (SC) [339] Updated 30 Jun 2022
30 May 2022 Regulatory Status The US FDA accepts for priority review of the supplemental Biologics License Application (sBLA) for Prurigo nodularis (Treatment-experienced) (SC,Injection) [339] Updated 30 Jun 2022
21 May 2022 Trial Update Sanofi and Regeneron Pharmaceuticals complete a phase III trial in Asthma (In adolescents, In adults, Adjunctive treatment) in India and China (SC) (NCT03782532) Updated 14 Jun 2022
20 May 2022 Phase Change - Registered Registered for Eosinophilic oesophagitis (In adolescents, In adults, In the elderly) in USA (SC) [263] Updated 24 May 2022
20 May 2022 Regulatory Status Sanofi announces intention to submit regulatory applications to regulatory authorities for Eosinophilic oesophagitis in additional undisclosed countries, by the end of 2022 [263] Updated 24 May 2022
13 May 2022 Scientific Update Pharmacodynamics data from the phase III LIBERTY ASTHMA QUEST trial in Asthma presented at the 118th International Conference of the American Thoracic Society (ATS-2022) [185] Updated 17 Jul 2022
13 May 2022 Scientific Update Updated efficacy data from the phase III LIBERTY ASTHMA TRAVERSE trial in Asthma presented at the 118th International Conference of the American Thoracic Society (ATS-2022) [192] Updated 17 Jul 2022
13 May 2022 Scientific Update Updated efficacy data from the phase III LIBERTY ASTHMA VOYAGE trial in Asthma presented at the 118th International Conference of the American Thoracic Society (ATS-2022) [163] Updated 17 Jul 2022
13 May 2022 Scientific Update Updated efficacy data from the phase III LIBERTY ASTHMA VOYAGE trial in Asthma presented at the 118th International Conference of the American Thoracic Society (ATS-2022) [162] Updated 17 Jul 2022
05 May 2022 Regulatory Status Sanofi and Regeneron to submit a regulatory application for pruritus in 2025 (Sanofi pipeline, May 2022) Updated 05 May 2022
04 May 2022 Phase Change - Preregistration Preregistration for Atopic dermatitis (In children, In infants, Treatment-experienced) in European Union (SC) [12] Updated 09 May 2022
04 May 2022 Phase Change - Preregistration Preregistration for Eosinophilic oesophagitis (In adolescents, In adults) in European Union (SC) before May 2022 [12] Updated 09 May 2022
11 Apr 2022 Regulatory Status 3655693: post hoc analysis, hence data not covered Updated 11 Apr 2022
07 Apr 2022 Phase Change - Registered Registered for Asthma (Adjunctive treatment, In children) in Iceland, Norway, Liechtenstein, European Union (SC) [128] Updated 08 Apr 2022
04 Apr 2022 Regulatory Status The US FDA has given PDUFA for the sBLA for Dupilumab in Eosinophilic oesophagitis (In adolescents, In adults, In the elderly) by August 3rd, 2022 [264] Updated 24 May 2022
04 Apr 2022 Regulatory Status US FDA accepted Dupixent® (dupilumab) for Priority Review in Eosinophilic esophagitis (In adolescents, In adults, In elderly) [264] Updated 07 Apr 2022
29 Mar 2022 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In children) in Canada (SC) [135] Updated 30 Mar 2022
28 Mar 2022 Phase Change - Registered Registered for Asthma (Adjunctive treatment, In children) in Canada (SC) [135] Updated 30 Mar 2022
26 Feb 2022 Scientific Update Adverse events and efficacy data from a phase III trial in Eosinophilic osophagitis presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2022) [277] Updated 01 Mar 2022
26 Feb 2022 Scientific Update Top-line safety, immunogenicity and efficacy data from the phase III CUPID (LIBERTY-CUPID) trial in Chronic urticaria presented at the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [239] Updated 01 Mar 2022
25 Feb 2022 Scientific Update Efficacy data from a phase III LIBERTY ASTHMA QUEST and LIBERTY ASTHMA TRAVERSE trial in Asthma presented at the 2022 Annual Meeting of the American Academy of Allergy, Asthma and Immunology(AAAAI-2022) [170] Updated 13 Apr 2022
25 Feb 2022 Scientific Update Efficacy and safety data from the phase III CUPID (LIBERTY-CUPID) trial in Chronic urticaria presented at the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [242] Updated 11 Apr 2022
25 Feb 2022 Scientific Update Efficacy data from a phase III trial in Eosinophilic oesophagitis presented at the annual meeting of the American Academy of Allergy, Asthma and Immunology 2022 [278] Updated 11 Apr 2022
25 Feb 2022 Scientific Update Efficacy data from a phase-III trial in Chronic rhinosinusitis with nasal polyps presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [58] [57] Updated 11 Apr 2022
25 Feb 2022 Scientific Update Pharmacodynamics data from the phase III LIBERT ASTHMA VOYAGE trial in Asthma presented at American Academy of Allergy, Asthma and Immunology Annual Meeting (AAAAI-2022) [161] Updated 11 Apr 2022
25 Feb 2022 Scientific Update Updated safety data from phase III open-label extension trial in Atopic dermatitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2022) [90] Updated 08 Apr 2022
18 Feb 2022 Trial Update Sanofi in collaboration with Regeneron completes phase III trial for Asthma in USA, France, the Netherlands, Germany, Belgium (NCT03620747) Updated 11 Apr 2022
18 Feb 2022 Scientific Update Interim efficacy and adverse events data from a phase-III (CUPID STUDY B) trial in chronic spontaneous Urticaria released by Sanofi [237] Updated 21 Feb 2022
14 Feb 2022 Regulatory Status The US FDA accepts for priority review of the supplemental Biologics License Application (sBLA) for Atopic dermatitis (In children, In infants, Treatment-experienced) (SC) [15] (Sanofi pipeline, February 2022) Updated 14 Feb 2022
11 Feb 2022 Regulatory Status Sanofi and Regeneron plan to submit a regulatory application for Rhinosinusitis in 2025 (Sanofi pipeline, August 2022) Updated 03 Aug 2022
11 Feb 2022 Regulatory Status Sanofi and Regenerone plans to submit a regulatory application for for Rhinosinusitis in 2024 (Sanofi pipeline, February 2022) Updated 11 Feb 2022
10 Feb 2022 Phase Change - Preregistration Preregistration for Atopic dermatitis (In children, In infants, Treatment-experienced) in USA (SC) [15] (Sanofi pipeline, February 2022) Updated 14 Feb 2022
03 Feb 2022 Trial Update Sanofi and Regeneron Pharmaceuticals complete the phase-III trial in Prurigo nodularis (Treatment-experienced) in USA, Argentina, China, France, Hungary, Japan, South Korea, Mexico, Russia (SC) (NCT04183335) (EUDRACT2019-003774-41) Updated 25 Feb 2022
31 Jan 2022 Regulatory Status CHMP adopts positive opinion for approval of dupilumab for Asthma (Adjunctive treatment, In children) in European Union [129] Updated 01 Feb 2022
19 Jan 2022 Regulatory Status Sanofi and Regenerone plans to submit a regulatory applications for Prurigo nodularis in the first half of 2022 (Sanofi pipeline, February 2022) [34] [347] Updated 30 Jun 2022
19 Jan 2022 Scientific Update Positive efficacy and safety data from the phase III PRIME trial in Prurigo nodularis released by Regeneron Pharmaceuticals [347] Updated 09 May 2022
13 Jan 2022 Phase Change - III Phase-III clinical trials in Pruritus in Hungary (SC) (EudraCT2021-004315-76) Updated 09 Mar 2022
13 Jan 2022 Phase Change - III Phase-III clinical trials in Pruritus in Italy (SC) (EudraCT2021-004315-76) Updated 09 Mar 2022
31 Dec 2021 Patent Information Regeneron Pharmaceuticals has multiple patent protections for dupilumab in the US, European Union and Japan, as of December 2021 [361] Updated 26 Apr 2022
13 Dec 2021 Regulatory Status Sanofi announces intention to submit regulatory application to the regulatory body for Atopic dermatitis (In children, In infants) in European Union in the first half of 2022 Updated 09 May 2022
13 Dec 2021 Regulatory Status Sanofi announces intention to submit regulatory application to the regulatory body for Atopic dermatitis (In children, In infants) in USA in 2021 Updated 14 Feb 2022
13 Dec 2021 Scientific Update Updated efficacy and adverse events data from the phase III LIBERTY AD PEDS trial in Atopic dermatitis released by Sanofi [71] Updated 17 Dec 2021
08 Dec 2021 Regulatory Status Sanofi expects a decision from the European Medicines Agency (EMA) for dupilumab for uncontrolled severe Asthma (In children), in Q1 2022 [153] Updated 14 Dec 2021
08 Dec 2021 Scientific Update Updated efficacy and adverse events data from the phase III LIBERTY ASTHMA VOYAGE trial in Asthma released by Sanofi [153] Updated 14 Dec 2021
22 Nov 2021 Trial Update Regeneron Pharmaceuticals and Sanofi completes the phase III PRIME2 trials in Prurigo nodularis (Treatment-resistant) in England, Chile, France, Hungary, Italy, Portugal, Spain, South Korea, Taiwan, United Kingdom, USA, Canada (SC) (NCT04202679) (Eudra CT 2019-003801-90) Updated 13 Dec 2021
04 Nov 2021 Scientific Update Interim adverse events and efficacy data from a phase III SOLO-CONTINUE trial in atopic dermatitis presented at the 2021 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2021) [78] Updated 03 Jan 2022
04 Nov 2021 Scientific Update Interim adverse events and pharmacodynamics data from a phase III LIBERTY AD ADOL trial in atopic dermatitis presented at the 2021 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI-2021) [102] Updated 03 Jan 2022
04 Nov 2021 Scientific Update Efficacy data from the phase III LIBERT ASTHMA QUEST trial in Asthma presented at Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology 2021 (ACAAI-2021) [183] Updated 31 Dec 2021
04 Nov 2021 Scientific Update Pharmacodynamics data from the phase III LIBERT ASTHMA VOYAGE trial in Asthma presented at Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology 2021 (ACAAI-2021) [158] Updated 31 Dec 2021
04 Nov 2021 Scientific Update Pooled efficacy data from the phase III SINUS-24 and SINUS-52 trials in Rhinosinusitis presented at Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology 2021 (ACAAI-2021) [56] Updated 31 Dec 2021
04 Nov 2021 Phase Change - Preregistration Preregistration for Eosinophilic oesophagitis (In adolescents, In adults) in USA (SC) before November 2021 [238] Updated 02 Dec 2021
29 Oct 2021 Biomarker Update Biomarkers information updated Updated 31 Oct 2021
26 Oct 2021 Scientific Update Efficacy and adverse events data of a phase III (part B) trial in Eosinophilic oesophagitis released by the company [279] Updated 26 Oct 2021
25 Oct 2021 Scientific Update Efficacy and safety data from the phase III PRIME2 trial in Prurigo nodularis released by Sanofi [348] Updated 25 Oct 2021
20 Oct 2021 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In children) in USA (SC) [125] Updated 09 Feb 2022
20 Oct 2021 Phase Change - Registered Registered for Asthma (Adjunctive treatment, In children) in USA (SC) [125] Updated 25 Oct 2021
18 Oct 2021 Regulatory Status National Institute for Health and Care Excellence recommends approval of dupilumab for Asthma (In adolescents, In adults) in United Kingdom [127] Updated 06 Jan 2022
05 Oct 2021 Scientific Update Updated efficacy and safety data from a phase III part C trial in Eosinophilic esophagitis presented at the30th United European Gastroenterology Week (UEGW-2021) [368] Updated 20 Dec 2021
24 Sep 2021 Trial Update Sanofi completes a phase I trial in volunteers in USA (SC) (NCT05976386) Updated 09 Aug 2023
14 Sep 2021 Phase Change - II Phase-II clinical trials in Milk hypersensitivity (Adjunctive treatment, In children, In adolescents, In adults) in USA (SC) (NCT04148352) Updated 14 Sep 2021
05 Sep 2021 Scientific Update Efficacy data from the phase III LIBERTY ASTHMA QUEST trial in Asthma presented at the 31st Annual Congress of the European Respiratory Society (ERS-2021) [160] Updated 09 Feb 2022
05 Sep 2021 Scientific Update Efficacy data from the phase III LIBERTY ASTHMA QUEST trial in Asthma presented at the 31st Annual Congress of the European Respiratory Society (ERS-2021) [159] Updated 09 Feb 2022
04 Sep 2021 Scientific Update Efficacy and safety data from phase II/III LIBERTY AD PRESCHOOL trial in Atopic dermatitis (In children, In infants) released by Sanofi [105] Updated 04 Sep 2021
29 Jul 2021 Regulatory Status Sanofi announces intention to launch dupilumab as 200mg single-dose pre-filled pen for treatment of Atopic dermatitis, Asthma, Rhinosinusitis in August 2021 [9] Updated 30 May 2023
29 Jul 2021 Regulatory Status US FDA approves dupilumab as 200mg single-dose pre-filled pen for treatment of Atopic dermatitis, Asthma and Rhinosinusitis [9] Updated 09 Aug 2021
29 Jul 2021 Scientific Update Safety, Immunogenicity and efficacy data from the phase III CUPID trial in Chronic urticaria released by Sanofi and Regeneron Pharmaceuticals [239] Updated 02 Aug 2021
23 Jul 2021 Trial Update Regeneron Pharmaceuticals, Sanofi, and Aimmune Therapeutics completes a phase II trial for Peanut hypersensitivity (Adjunctive therapy, In children, In adolescents) (NCT03682770) Updated 09 Nov 2021
08 Jul 2021 Trial Update Regeneron Pharmaceuticals and Sanofi completes the Liberty AD PRESCHOOL phase II/III trial in Atopic dermatitis (In infants, In children, Treatment-experienced) in USA, United Kingdom, Poland and Germany (NCT03346434) Updated 05 Oct 2021
07 Jul 2021 Trial Update Sanofi-Aventis GmbH and Charité University of Berlin completes a phase II trial in Chroic urticaria (In adults, In the elderly, Treatment-experienced) in Germany (EudraCT2017-004458-41) . Updated 21 Oct 2021
06 Jul 2021 Patent Information Regeneron Pharmaceuticals has patent protection for composition of matter, methods of treatment and formulation related to dupilumab in the US and the European Union prior to December 2020 [362] Updated 06 Jul 2021
02 Jul 2021 Scientific Update Efficacy and adverse event data from phase III VOYAGE trial were presented at 117th International Conference of the American Thoracic Society (ATS-2021) [155] Updated 02 Jul 2021
18 Jun 2021 Phase Change - Marketed Launched for Atopic dermatitis (In children) in Canada (SC) [16] Updated 21 Jun 2021
18 Jun 2021 Phase Change - Marketed Launched for Rhinosinusitis (Adjunctive treatment) in Canada (SC) [16] Updated 21 Jun 2021
14 Jun 2021 Trial Update Regeneron Pharmaceuticals reinitiates an expanded access trial of dupilumab for Atopic dermatitis, Asthma, Allergic bronchopulmonary aspergillosis, Bullous pemphigoid, Eosinophilic oesophagitis, Prurigo nodularis and Rhinosinusitis (SC) (NCT04776694) Updated 02 Jul 2021
17 May 2021 Scientific Update Updated efficacy data from the phase III LIBERTY ASTHMA VOYAGE trial in Asthma released by Regeneron [154] Updated 23 May 2021
14 May 2021 Scientific Update Pooled efficacy data from the phase III SINUS-24 and SINUS-52 trials in Rhinosinusitis presented at the 117th International Conference of the American Thoracic Society (ATS-2021) [317] [316] Updated 03 Jul 2021
14 May 2021 Scientific Update Updated efficacy and adverse events data from phase III LIBERTY ASTHMA TRAVERSE Open Label Extension trial in Asthma presented at the 117th International Conference of the American Thoracic Society (ATS-2021) [187] [186] [190] Updated 30 Jun 2021
14 May 2021 Phase Change - II Phase-II clinical trials in Eosinophilic gastroenteritis (In children, In adults, In the elderly) in USA (SC) (NCT03678545) Updated 26 May 2021
12 May 2021 Trial Update Regeneron Pharmaceuticals completes phase II trial in Peanut hypersensitivity (In children, In adolescents) in USA and Canada (SC) (NCT03793608) Updated 31 Aug 2021
06 May 2021 Phase Change - Preregistration Preregistration for Asthma (Adjunctive treatment, In children) in European Union (SC) before May 2021 [130] Updated 12 May 2021
30 Apr 2021 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in France (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults, In children, Adjunctive treatment) in Australia (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Asthma (In adolescents, In the elderly, In adults) in Sweden (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, Monotherapy) in Australia (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis (Combination therapy, Adjunctive treatment, Monotherapy) in USA (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis (In adolescents, In children) in Hungary (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis (In adolescents, In children) in Poland (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis (In adolescents, In children) in United Kingdom (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis (Monotherapy) in Hong Kong (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis in Israel (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis in Malaysia (SC) [69] Updated 30 Apr 2021
30 Apr 2021 Phase Change - Marketed Launched for Atopic dermatitis in Sweden (SC) [69] Updated 30 Apr 2021
21 Apr 2021 Scientific Update Efficacy data from the phase III SINUS-52 trial in Rhinosinusitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021) [324] Updated 22 Apr 2021
20 Apr 2021 Trial Update Regeneron Pharmaceuticals suspends an expanded access trial of dupilumab for Atopic dermatitis, Asthma, Allergic bronchopulmonary aspergillosis, Bullous pemphigoid, Eosinophilic oesophagitis, Prurigo nodularis and Rhinosinusitis (SC) (NCT04776694) Updated 06 May 2021
14 Apr 2021 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In adults, In adolescents) in Japan (SC) (NCT04417894) Updated 26 Jan 2023
14 Apr 2021 Trial Update Regeneron Pharmaceuticals and Sanofi initiate enrolment in a phase III trial for Atopic dermatitis (In adults, In adolescents) in USA (SC) in April 2021 (NCT04417894) Updated 27 May 2021
31 Mar 2021 Phase Change - Discontinued(II) Discontinued - Phase-II for Grass pollen hypersensitivity (Adjunctive treatment) in USA (SC) prior to March 2021 [295] Updated 06 Aug 2021
04 Mar 2021 Regulatory Status FDA assigns PDUFA action date of 21/10/2021 for dupilumab for Asthma (In children, Adjunctive treatment) [126] Updated 25 Oct 2021
04 Mar 2021 Phase Change - Preregistration Preregistration for Asthma (Adjunctive treatment, In children) in USA (SC) in March 2021 [126] Updated 05 Mar 2021
04 Mar 2021 Regulatory Status US FDA accepts sNDA for Dupilumab for Asthma (In children, Adjunctive treatment) for review [126] Updated 05 Mar 2021
02 Mar 2021 Trial Update Regeneron Pharmaceuticals initiates an expanded access trial of dupilumab for Atopic dermatitis, Asthma, Allergic bronchopulmonary aspergillosis, Bullous pemphigoid, Eosinophilic oesophagitis, Prurigo nodularis and Rhinosinusitis (SC) (NCT04776694) Updated 05 Mar 2021
26 Feb 2021 Scientific Update Efficacy and adverse evets data from the phase III LIBERTY AD PEDS trial in Atopic dermatitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021) [70] [69] Updated 22 Apr 2021
26 Feb 2021 Scientific Update Efficacy data from a phase III trial in Eosinophilic oesophagitis presented at Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021) [281] Updated 22 Apr 2021
26 Feb 2021 Scientific Update Updated efficacy data from a phase III LIBERTY ASTHMA QUEST trial in Asthma presented at the 2021 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021) [176] Updated 22 Apr 2021
26 Feb 2021 Scientific Update Updated efficacy data from a phase III LIBERTY ASTHMA TRAVERSE trial in Asthma presented at the 2021 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2021) [188] Updated 22 Apr 2021
23 Feb 2021 Phase Change - Registered Registered for Atopic dermatitis (In children) in Canada (SC) [18] Updated 24 Feb 2021
05 Feb 2021 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, In children) in European Union (SC) in February 2021 [32] Updated 25 Feb 2021
15 Jan 2021 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Treatment-experienced, In infants, In children, In adolescents) in Japan (SC) (NCT04678882) (EudraCT2020-002601-26) Updated 26 Jan 2021
07 Jan 2021 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In adults, In adolescents) in Germany, Poland (SC) (EudraCT2019-003088-22) Updated 21 Jan 2021
22 Dec 2020 Trial Update Sanofi and Regeneron Pharmaceuticals plan a phase III trial for Atopic dermatitis (Treatment-experienced, In infants, In children, In adolescents) in Japan (SC, Injection), in January 2021 (NCT04678882) Updated 26 Jan 2021
10 Dec 2020 Trial Update Sanofi and Regeneron Pharmaceuticals initiates enrolment in the phase III LIBERTY-CINDU CUrIADS trial in Chronic urticaria (In adolescents, In adults, In children, In the elderly, Treatment-experienced) in Argentina, Canada and Japan after December 2020 (NCT04681729) (EudraCT2020-003756-33) Updated 05 Aug 2021
10 Dec 2020 Trial Update Sanofi and Regeneron Pharmaceuticals initiates enrolment in a phase-III clinical trials in Chronic urticaria (In adolescents, In adults, In children, In the elderly, Treatment-experienced) in USA and Germany (NCT04681729) (EudraCT2020-003756-33) Updated 24 Dec 2020
02 Dec 2020 Phase Change - II Phase-II clinical trials in Rhinosinusitis (Treatment-experienced) in Sweden, United Kingdom, Argentina, Belgium, Chile, China, Hungary, South Korea, Portugal, Russia, Spain (SC) (NCT04678856) Updated 27 Feb 2024
02 Dec 2020 Phase Change - II/III Phase-II/III clinical trials in Rhinosinusitis (In adolescents, In adults) in Canada (SC) (NCT04678856) Updated 28 Dec 2020
01 Dec 2020 Phase Change - III Phase-III clinical trials in Rhinosinusitis (In adolescents, In adults) in USA (SC) (NCT04684524) (EudraCT2020-002999-12) Updated 31 Dec 2020
30 Nov 2020 Phase Change - Registered Registered for Atopic dermatitis (In children, Adjunctive treatment) in United Kingdom (SC) Updated 03 Dec 2020
16 Nov 2020 Phase Change - III Phase-III clinical trials in Prurigo nodularis (Treatment-resistant) in England, Chile, France, Hungary, Italy, Portugal, Spain, South Korea, Taiwan, United Kingdom (SC) (NCT04202679) (Eudra CT 2019-003801-90) Updated 13 Dec 2021
16 Nov 2020 Trial Update Regeneron Pharmaceuticals and Sanofi initiated the phase III PRIME2 trials in Prurigo nodularis (Treatment-resistant) in USA (SC) (NCT04202679) (Eudra CT 2019-003801-90) Updated 13 Dec 2021
13 Nov 2020 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in Canada (SC) [136] Updated 24 Nov 2020
12 Nov 2020 Phase Change - Preregistration Preregistration for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in Canada (SC) before November 2020 [136] Updated 24 Nov 2020
12 Nov 2020 Phase Change - Registered Registered for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in Canada (SC) [136] Updated 24 Nov 2020
29 Oct 2020 Trial Update Sanofi plans a phase III trial for Chronic urticaria in late in 2020 or early 2021 [246] Updated 13 Sep 2021
29 Oct 2020 Trial Update Sanofi plans a phase III trial for Rhinosinusitis in late in 2020 or early 2021 [246] Updated 31 Dec 2020
29 Oct 2020 Trial Update Sanofi plans a phase III trial for Sinusitis in late in 2020 or early 2021 [246] Updated 28 Dec 2020
28 Oct 2020 Phase Change - II/III Phase-II/III clinical trials in Bullous pemphigoid in USA, Japan, Germany, Australia (SC) (NCT04206553) Updated 01 Dec 2020
26 Oct 2020 Scientific Update Updated efficacy data from a phase III trial for Eosinophilic oesophagitis released by Sanofi [280] Updated 28 Oct 2020
16 Oct 2020 Phase Change - Preregistration Preregistration for Atopic dermatitis (In children, Adjunctive treatment) in United Kingdom (SC) [33] Updated 03 Dec 2020
16 Oct 2020 Regulatory Status Committee for Medicinal Products for Human Use of EMA recommends approval of dupilumab for Atopic dermatitis (Adjunctive treatment, In children) [33] Updated 20 Oct 2020
14 Oct 2020 Company Involvement Aimmune Therapeutics has been acquired by Nestle Updated 16 Oct 2020
13 Oct 2020 Regulatory Status Sanofi announces intention to submit regulatory application to the regulatory body for Asthma (In children, Adjunctive treatment) in European Union, in Q1 2021 [156] Updated 05 Mar 2021
13 Oct 2020 Regulatory Status Sanofi announces intention to submit regulatory application to the regulatory body for Asthma (In children, Adjunctive treatment) in USA, in Q1 2021 [156] Updated 14 Oct 2020
13 Oct 2020 Scientific Update Efficacy and adverse events data from the phase III LIBERTY ASTHMA VOYAGE trial in Asthma released by Sanofi [156] Updated 14 Oct 2020
11 Oct 2020 Scientific Update Adverse events and safety data from a phase III part A trial in Eosinophilic esophagitis presented at the 28th United European Gastroenterology Week (UEGW-2020) [282] Updated 07 Dec 2020
09 Oct 2020 Trial Update Regeneron Pharmaceuticals terminates a phase II clinical trial in Prostate cancer (Neoadjuvant therapy) in USA (SC) due to low accrual due to COVID-2019 pandemic (NCT03886493) Updated 19 Oct 2020
14 Sep 2020 Regulatory Status Dupilumab receives Breakthrough Therapy status for Eosinophilic oesophagitis (In adults, In adolescents, In the elderly, In children) in USA Updated 15 Sep 2020
08 Sep 2020 Phase Change - II Phase-II clinical trials in Aspergillosis (Allergic bronchopulmonary aspergillosis) in USA, Canada, Bulgaria, France, Germany, Hungary, Japan, Netherlands, Poland, Romania and United Kingdom (SC) (NCT04442269) (EudraCT2019-002619-24) Updated 01 Mar 2022
08 Sep 2020 Phase Change - II Phase-II clinical trials in Asthma (Treatment-experienced, In adults, In the elderly, In adolescents) in Romania, Germany, Hungary, United Kingdom, Netherlands (SC) (NCT04442269) Updated 14 Oct 2020
08 Sep 2020 Scientific Update Efficacy and safety data from the phase III LIBERTY ASTHMA TRAVERSE trial in Asthma released by Sanofi [189] Updated 09 Sep 2020
07 Sep 2020 Scientific Update Efficacy data from the phase III LIBERTY ASTHMA VENTURE trial in Asthma presented at the 30th Annual Congress of the European Respiratory Society (ERS-2020) [206] Updated 15 Dec 2020
01 Sep 2020 Phase Change - III Phase-III clinical trials in Eosinophilic oesophagitis (In children) in Canada (SC) (NCT04394351) Updated 17 Dec 2021
01 Sep 2020 Phase Change - III Phase-III clinical trials in Eosinophilic oesophagitis (In children) in USA (SC) (NCT04394351) Updated 23 Sep 2020
01 Sep 2020 Phase Change - II Phase-II clinical trials in Pruritus in USA (SC) (NCT04256759) Updated 07 Sep 2020
26 Aug 2020 Trial Update Regeneron Pharmaceuticals and Sanofi completes the phase III LIBERTY ASTHMA VOYAGE trial in Asthma (In children, Adjunctive treatment) in the US, Ukraine, Turkey, Spain, South Africa, Russia, Romania, Poland, Mexico, Lithuania, Italy, Hungary, Colombia, Chile, Canada, Brazil, Australia and Argentina (SC) (NCT02948959) (EudraCT2016-001607-23) Updated 24 Sep 2020
18 Aug 2020 Phase Change - Registered Registered for Rhinosinusitis (Adjunctive treatment) in Canada (SC) [308] Updated 24 Aug 2020
01 Aug 2020 Phase Change - II Phase-II DUPSHE clinical trials in Eczema (Treatment-experienced) in Netherlands (SC) (NCT04512339) Updated 07 Jun 2023
01 Aug 2020 Phase Change - Preregistration Preregistration for Rhinosinusitis (Adjunctive treatment) in Canada (SC) before August 2020 [308] Updated 24 Aug 2020
23 Jun 2020 Active Status Review NCT04442269 - FET added Updated 23 Jun 2020
22 Jun 2020 Trial Update Regeneron Pharmaceuticals in collaboration with Sanofi plans a phase III trial in Allergic bronchopulmonary aspergillosis (Treatment-experienced) (SC) in September 2020 (NCT04442269) (EudraCT2019-002619-24) Updated 14 Oct 2020
19 Jun 2020 Phase Change - Registered Registered for Atopic dermatitis (In adults) in China (SC) [20] Updated 23 Jun 2020
12 Jun 2020 Phase Change - III Phase-III clinical trials in Chronic obstructive pulmonary disease in Serbia, South Africa, Brazil, Colombia, Peru, Australia (SC) (NCT04456673) (EudraCT2018-001954-91) Updated 25 May 2023
10 Jun 2020 Regulatory Status Sanofi and Regenerone announce intension to submit a regulatory application for Chronic obstructive pulmonary disease, in 2024 [227] Updated 08 Mar 2024
10 Jun 2020 Regulatory Status Regeneron and Sanofi plans to submit a regulatory application for Bullous pemphigoid, in 2025 (Sanofi pipeline, August 2022) [227] Updated 03 Aug 2022
10 Jun 2020 Trial Update Regeneron and Sanofi plans a confirmatory phase III trial for Chronic obstructive pulmonary disease in the third quarter of 2020 [227] Updated 16 Jun 2020
05 Jun 2020 Trial Update Regeneron Pharmaceuticals and Sanofi plans a phase III trial in Atopic dermatitis (In adolescents, In adults)(SC, Injection) in November 2020 (NCT04417894) Updated 21 Jan 2021
28 May 2020 Phase Change - No development reported No recent reports of development identified for phase-I development in Allergic-asthma(Combination therapy) in United Kingdom (SC) Updated 28 May 2020
28 May 2020 Phase Change - No development reported No recent reports of development identified for phase-I development in Allergic-asthma(Combination therapy) in USA (SC) Updated 28 May 2020
28 May 2020 Phase Change - No development reported No recent reports of development identified for phase-I development in Allergic-asthma(Monotherapy) in United Kingdom (SC) Updated 28 May 2020
28 May 2020 Phase Change - No development reported No recent reports of development identified for phase-I development in Allergic-asthma(Monotherapy) in USA (SC) Updated 28 May 2020
26 May 2020 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, In children) in USA (SC) [21] Updated 28 May 2020
26 May 2020 Scientific Update Updated safety and efficacy data from a phase III trial in Atopic dermatitis released by Regeneron Pharmaceuticals [21] Updated 28 May 2020
22 May 2020 Scientific Update Efficacy and adverse events data from a phase III trial for Eosinophilic oesophagitis released by Regeneron and Sanofi [283] Updated 29 May 2020
19 May 2020 Trial Update Regeneron Pharmaceuticals in a collaboration with Sanofi plans a phase III EoE KIDS trial in Eosinophilic oesophagitis (In children) (SC, Injection) in September 2020 (NCT04394351) Updated 23 Sep 2020
15 May 2020 Scientific Update Efficacy data from a phase III SINUS-24 and SINUS-52 trial in Rhinosinusitis presented at the 116th International Conference of the American Thoracic Society (ATS-2020) [312] Updated 14 Jul 2020
15 Apr 2020 Trial Update Sanofi and Regeneron initiates phase-III BOREAS clinical trials in Chronic obstructive pulmonary disease in Spain (SC) after April 2019 (NCT03930732) (EudraCT2018-001953-28) Updated 16 Jun 2020
09 Apr 2020 Phase Change - III Phase-III clinical trials in Chronic obstructive pulmonary disease in Spain (SC) (EudraCT2018-001954-91) Updated 15 May 2020
06 Apr 2020 Phase Change - III Phase-III clinical trials in Chronic obstructive pulmonary disease in Belgium, Greece, Portugal, France, United Kingdom, Lithuania, Netherlands, Latvia (SC) (EudraCT2018-001954-91) Updated 29 Mar 2023
06 Apr 2020 Trial Update Sanofi initiates a phase III NOTUS trial for Chronic obstructive pulmonary disease in Bulgaria, Poland, Hungary, Czech Republic, Slovakia and Romania (SC) (EudraCT2018-001954-91) Updated 29 Mar 2023
03 Apr 2020 Scientific Update Efficacy and safety data from a phase III trial in Atopic dermatitis released by Regeneron Pharmaceuticals [68] Updated 06 Apr 2020
31 Mar 2020 Phase Change - Registered Registered for Rhinosinusitis (Adjunctive treatment, In adults) in Japan (SC) before March 2020 [309] Updated 09 May 2020
25 Mar 2020 Phase Change - II/III Phase-II/III clinical trials in Bullous pemphigoid in France (SC) (EudraCT2019-003520-20) Updated 16 Jun 2020
13 Mar 2020 Trial Update Regeneron completes a phase II trial in Atopic dermatitis (Combination therapy) in USA, Netherlands, Germany, Spain (SC) (NCT03736967) (EudraCT2018-001543-30) Updated 14 Aug 2020
13 Mar 2020 Scientific Update Adverse evets data from the phase III SINUS‑52 trials in Rhinosinusitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2020) [320] Updated 07 May 2020
13 Mar 2020 Scientific Update Efficacy data from the phase III SINUS-24 trial in Rhinosinusitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2020) [326] Updated 05 May 2020
13 Mar 2020 Scientific Update Pooled efficacy and safety data from the two phase III SINUS-24 and SINUS‑52 trials in Rhinosinusitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2020) [313] Updated 05 May 2020
31 Jan 2020 Phase Change - Preregistration Preregistration for Atopic dermatitis (Adjunctive treatment, In children) in European Union (SC) [34] Updated 10 Feb 2020
28 Jan 2020 Regulatory Status FDA assigns PDUFA action date of 26/05/2020 for dupilumab for Atopic dermatitis (Adjunctive treatment, In children) [50] Updated 13 Feb 2020
28 Jan 2020 Phase Change - Preregistration Preregistration for Atopic dermatitis (Adjunctive treatment, In children) in USA (SC) [50] Updated 06 Feb 2020
28 Jan 2020 Regulatory Status Dupilumab receives priority review status for Atopic dermatitis (Adjunctive treatment ,In children) in USA (SC) [50] Updated 28 Jan 2020
27 Dec 2019 Trial Update Regeneron Pharmaceuticals plans a phase II/III (LIBERTY-BP) trial for Bullous Pemphigoid in December 2019 (NCT04206553) Updated 16 Jun 2020
16 Dec 2019 Phase Change - III Phase-III clinical trials in Prurigo nodularis (Treatment-experienced) in Canada (SC) (NCT04202679) Updated 23 Dec 2019
12 Dec 2019 Phase Change - III Phase-III clinical trials in Prurigo nodularis (Treatment-experienced) in USA, Argentina, China, France, Hungary, Japan, South Korea, Mexico, Russia (SC) (NCT04183335) (EUDRACT2019-003774-41) Updated 26 Dec 2019
11 Dec 2019 Phase Change - III Phase-III clinical trials in Chronic urticaria (Treatment-experienced, In children, In adults, In adolescents, In the elderly) in Russia, China (SC) (NCT04180488) Updated 02 Aug 2021
11 Dec 2019 Phase Change - III Phase-III clinical trials in Chronic urticaria (In adolescents, In adults, In children, In the elderly, Treatment-experienced) in United Kingdom, Spain, Hungary, Japan, Canada, Argentina, France (SC) after December 2019 (NCT04180488) Updated 16 Jun 2020
11 Dec 2019 Phase Change - III Phase-III clinical trials in Chronic urticaria (Treatment-experienced, In adolescents, In adults, In children, In the elderly) in Germany (SC) after December 2019 (NCT04180488) Updated 16 Jun 2020
09 Dec 2019 Trial Update Regeneron Pharmaceuticals and Sanofi completes a phase I trial for Allergic asthma (Monotherapy, Combination therapy) in USA and United Kingdom (SC) (NCT03112577) Updated 28 Jan 2020
20 Nov 2019 Phase Change - III Phase-III clinical trials in Chronic urticaria (Treatment-experienced, In children, In adults, In the elderly) in USA (SC) (NCT04180488) Updated 18 Dec 2019
20 Nov 2019 Trial Update Regeneron and Sanofi plans the phase III CUPID trial for Chronic urticaria (Treatment-experienced, In children, In adolescents, In adults, In the elderly) (SC) [369] (NCT04180488) Updated 15 Nov 2019
05 Nov 2019 Trial Update Regeneron and Sanofi plans the phase III PRIME trial for Prurigo nodularis [369] Updated 15 Nov 2019
05 Nov 2019 Regulatory Status Regeneron announces intention to submit a Marketing Authorisation Application (MAA) to the EMA for Atopic dermatitis (In children) in by the end of 2019 [369] Updated 13 Nov 2019
05 Nov 2019 Trial Update Regeneron and Sanofi plans a phase III trial for Bullous pemphigoid [369] Updated 13 Nov 2019
31 Oct 2019 Phase Change - III Phase-III clinical trials in Bullous pemphigoid (SC) after October 2019 [34] Updated 10 Feb 2020
29 Oct 2019 Phase Change - Registered Registered for Rhinosinusitis (Adjunctive treatment, In adults) in Liechtenstein (SC), European Union (SC), Iceland (SC), Norway (SC) [305] Updated 05 Nov 2019
21 Oct 2019 Phase Change - III Phase-III clinical trials in Eosinophilic oesophagitis (In adolescents, In adults) in Portugal (SC) (EudraCT2018-000844-25) Updated 09 May 2022
11 Oct 2019 Trial Update Sanofi and Regeneron Pharmaceuticals complete the phase II/III LIBERTY ASTHMA TRAVERSE trial in Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) in USA, Argentina, Belgium, Brazil, Colombia, Denmark, Hungary, Romania, Taiwan, Sweden, Australia, Canada, Chile, France, Germany, Israel, Italy, Japan, South Korea, Mexico, Russia, Netherlands, Poland, South Africa, Spain, Turkey, Ukraine and the UK (NCT02134028; EudraCT2013-003856-19) Updated 23 Oct 2019
28 Sep 2019 Scientific Update Efficacy data from a phase III LIBERTY ASTHMA QUEST trial in Asthma presented at the 29th Annual Congress of the European Respiratory Society 2017 (ERS-2019) [180] [181] [179] [178] Updated 03 Mar 2020
28 Sep 2019 Scientific Update Pooled efficacy and safety data from the two phase III SINUS-24 and SINUS‑52 trials in Rhinosinusitis presented at the 29th Annual Congress of the European Respiratory Society (ERS-2019) [322] [321] Updated 03 Mar 2020
28 Sep 2019 Phase Change - Marketed Launched for Atopic dermatitis (In adolescents, Monotherapy, Treatment-experienced) in Canada (SC) [42] Updated 30 Sep 2019
27 Sep 2019 Phase Change - Preregistration Preregistration for Atopic dermatitis (In adolescents, Monotherapy, Treatment-experienced) in Canada (SC) before September 2019 [42] Updated 30 Sep 2019
27 Sep 2019 Phase Change - Registered Registered for Atopic dermatitis (In adolescents, Monotherapy, Treatment-experienced) in Canada (SC) [42] Updated 30 Sep 2019
20 Sep 2019 Phase Change - Preregistration Preregistration for Rhinosinusitis (Adjunctive treatment, In adults) in Japan (SC) [310] Updated 24 Sep 2019
20 Sep 2019 Regulatory Status The CHMP adopts positive opinion for approval of dupilumab for Rhinosinusitis (Adjunctive treatment) in European Union (In adults) (SC) [306] Updated 24 Sep 2019
10 Sep 2019 Trial Update Sanofi completes a phase III trial in Atopic dermatitis (Adjunctive treatment, In children) in USA, Canada, Czech Republic, Germany, Poland and United Kingdom (SC) (NCT03345914) Updated 04 Dec 2019
21 Aug 2019 Regulatory Status Dupilumab receives Orphan Drug status for Bullous pemphigoid in USA [253] [252] Updated 18 May 2020
07 Aug 2019 Trial Update Sanofi completes a phase II trial in Asthma in USA, Ukraine, Turkey, Russia, Poland, Mexico, Chile and Argentina (NCT03387852) Updated 30 Aug 2019
06 Aug 2019 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, In adolescents) in European Union, Norway, Iceland, Liechtenstein (SC) [35] Updated 09 Aug 2019
06 Aug 2019 Scientific Update Efficacy data from the phase III LIBERTY AD trial in Atopic Dermatitis (In adolescents) released by Sanofi and Regeneron Pharmaceuticals [35] Updated 09 Aug 2019
06 Aug 2019 Scientific Update Positive topline safety and efficacy data from a phase III trial in Atopic Dermatitis (In children) released by Regeneron Pharmaceuticals [67] Updated 09 Aug 2019
05 Aug 2019 Regulatory Status Regeneron announces intention to submit sBLA to the US FDA for Atopic dermatitis (In children) in the fourth quarter of 2019 [67] Updated 09 Aug 2019
15 Jul 2019 Phase Change - II Phase-II clinical trials in Prostate cancer (Neoadjuvant therapy) in USA (SC) (NCT03886493) Updated 18 Jul 2019
01 Jul 2019 Trial Update Sanofi and McMaster University initiates a phase III trial in Asthma (In adults, In the elderly) in Canada (SC, Injection) (NCT03884842) Updated 01 Feb 2023
27 Jun 2019 Phase Change - Preregistration Preregistration for Atopic dermatitis (In adolescents, Adjunctive treatment) in European Union (SC) before June 2019 [36] Updated 03 Jul 2019
27 Jun 2019 Regulatory Status The Committee for Medicinal Products for Human Use (CHMP) recommends approval of dupilumab as adjunctive treatment in adolscent patients for Atopic dermatitis (SC) [36] Updated 03 Jul 2019
26 Jun 2019 Phase Change - Marketed Launched for Rhinosinusitis (Adjunctive treatment) in USA (SC) after June 2019 [301] Updated 01 Jul 2019
26 Jun 2019 Phase Change - Registered Registered for Rhinosinusitis (Adjunctive treatment) in USA (SC) [301] Updated 01 Jul 2019
21 Jun 2019 Scientific Update Efficacy and adverse events data from a phase II trial in Asthma released by Regeneron [210] Updated 25 Jun 2019
13 Jun 2019 Trial Update Regeneron completes a phase II trial in Grass pollen hypersensitivity (Adjunctive treatment) in USA (SC) (NCT03558997) Updated 10 Jul 2019
11 Jun 2019 Phase Change - II Phase-II clinical trials in Atopic dermatitis (Combination therapy) in Spain, Netherlands, Germany (SC) (EudraCT2018-001543-30) Updated 14 Aug 2020
20 May 2019 Scientific Update Efficacy and adverse events data from the phase III ASTHMA VENTURE trial in Asthma presented at the 115th International Conference of the American Thoracic Society (ATS-2019) [204] Updated 23 Sep 2019
20 May 2019 Scientific Update Efficacy data from a phase III ASTHMA VENTURE trial in Asthma presented at the 115th International Conference of the American Thoracic Society (ATS-2019) [205] Updated 23 Sep 2019
17 May 2019 Scientific Update Efficacy data from phase III LIBERTY ASTHMA QUEST trial in Asthma presented at the 115th International Conference of the American Thoracic Society (ATS-2019) [182] Updated 24 Sep 2019
17 May 2019 Scientific Update Pooled safety and efficacy data from the phase III SINUS-24 and SINUS-52 trials in Rhinosinusitis presented at the 115th International Conference of the American Thoracic Society (ATS-2019) [315] [305] Updated 24 Sep 2019
08 May 2019 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in Norway, Austria, Denmark, Germany, Ireland, Netherlands, United Kingdom, Finland (SC) [131] Updated 29 May 2019
07 May 2019 Phase Change - Registered Registered for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in Iceland, Liechtenstein, Norway, European Union (SC) [131] Updated 27 May 2019
07 May 2019 Phase Change - Preregistration Preregistration for Rhinosinusitis (Adjunctive treatment) in European Union (SC) [307] Updated 14 May 2019
07 May 2019 Regulatory Status Regeneron Pharmaceuticals submits MAA to European Medicines Agency for Rhinosinusitis (Adjunctive treatment) in May 2019 [307] Updated 14 May 2019
15 Apr 2019 Phase Change - III Phase-III clinical trials in Chronic obstructive pulmonary disease in Finland (SC) (NCT03930732) (EudraCT2018-001953-28) Updated 29 Mar 2023
15 Apr 2019 Phase Change - III Phase-III clinical trials in Chronic obstructive pulmonary disease in Argentina, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Germany, Hungary, Israel, Italy, Japan, South Korea, Mexico, Poland, Romania, Russia, Slovakia, Sweden, Turkey and Ukraine (SC) (NCT03930732) (EudraCT2018-001953-28) Updated 16 Jun 2020
15 Apr 2019 Phase Change - III Phase-III clinical trials in Chronic obstructive pulmonary disease in USA (SC) (NCT03930732) Updated 02 May 2019
01 Apr 2019 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in Japan (SC) [137] Updated 14 May 2019
31 Mar 2019 Phase Change - Registered Registered for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in Japan (SC) [137] Updated 14 May 2019
25 Mar 2019 Phase Change - III Phase-III clinical trials in Chronic obstructive pulmonary disease in Hungary (SC) (EudraCT2018-001953-28) Updated 11 Apr 2019
25 Mar 2019 Phase Change - III Phase-III clinical trials in Chronic obstructive pulmonary disease in Sweden (SC) (EudraCT2018-001953-28 ) Updated 01 Apr 2019
21 Mar 2019 Trial Update Regeneron Pharmaceuticals initiates enrolment in a phase II trial in Peanut hypersensitivity (In children, In adolescents) in USA (SC) (NCT03793608) Updated 06 May 2019
12 Mar 2019 Phase Change - II Phase-II clinical trials in Peanut hypersensitivity (In adolescents, In children) in Canada (SC) after March 2019 (NCT03793608) Updated 31 Aug 2021
11 Mar 2019 Phase Change - Registered Registered for Atopic dermatitis (In adolescents, Monotherapy) in USA (SC) [30] Updated 13 Mar 2019
08 Mar 2019 Regulatory Status FDA assigns PDUFA action date of 26/06/2019 for Dupilumab for Rhinosinusitis (Adjunctive treatment) [303] Updated 30 May 2023
08 Mar 2019 Regulatory Status Dupilumab receives priority review status for Rhinosinusitis (Adjunctive treatment) in USA (SC) [302] Updated 12 Mar 2019
01 Mar 2019 Scientific Update Adverse events and efficacy data from a phase III trial in Atopic dermatitis presented at the 77th Annual Meeting of the American Academy of Dermatology (AAD-2019) [97] Updated 01 Jul 2019
01 Mar 2019 Regulatory Status CHMP adopts positive opinion for approval of dupilumab for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in European Union [132] Updated 05 Mar 2019
25 Feb 2019 Scientific Update Updated adverse events and efficacy data from the phase III SINUS-24 and SINUS-52 trial in Chronic rhinosinusitis with nasal polyps (CRSwNP) released by Regenron Pharmaceuticals [314] Updated 27 Feb 2019
22 Feb 2019 Scientific Update Efficacy and adverse events data from a phase III LIBERTY ASTHMA QUEST trial in Asthma (comorbid Allergic rhinitis) presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI, [175] Updated 19 Mar 2019
15 Feb 2019 Patent Information The European Patent Office and the USPTO revokes and invalidates Patent No. 2,990,420 and U.S. Patent No. 8,679,487 [364] Updated 22 Feb 2019
11 Feb 2019 Trial Update Regeneron Pharmaceuticals terminates a phase II trial in Atopic dermatitis (Combination therapy) in Germany and Spain (SC) (EudraCT2018-001543-30) Updated 14 Aug 2020
07 Feb 2019 Regulatory Status Regeneron announces intention to submit sBLA to the US FDA for Atopic dermatitis (In infants) in 2022 [22] Updated 18 Mar 2022
07 Feb 2019 Regulatory Status Sanofi announces intention to submit regulatory application for Peanut hypersensitivity (In Children, Combination therapy) in 2023 Updated 14 Feb 2019
07 Feb 2019 Regulatory Status Sanofi expects the EU regulatory decision for Atopic dermatitis (In adolescents) in the third quarter of 2019 [22] Updated 12 Feb 2019
07 Feb 2019 Regulatory Status Sanofi expects the EU regulatory decision for Asthma (In adults, In adolescents) in the second quarter of 2019 [22] Updated 12 Feb 2019
07 Feb 2019 Regulatory Status Sanofi expects the US regulatory decision for Atopic dermatitis (In adolescents) in the first quarter of 2019 [22] Updated 12 Feb 2019
25 Jan 2019 Phase Change - III Phase-III clinical trials in Asthma (In adolescents, In adults, Adjunctive treatment) in India, China (SC) (NCT03782532) Updated 04 Apr 2019
04 Jan 2019 Trial Update Regeneron Pharmaceuticals plans a phase II trial for Peanut hypersensitivity (In children, In adolescents) (NCT03793608) (EudraCT2018-003133-15) Updated 14 Jan 2019
31 Dec 2018 Phase Change - Preregistration Preregistration for Rhinosinusitis (Adjunctive treatment) in USA (SC) [304] Updated 20 Feb 2019
31 Dec 2018 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In adults) in Norway, Austria, Ireland (SC) Updated 13 Feb 2019
31 Dec 2018 Phase Change - Marketed Launched for Atopic dermatitis (Monotherapy, In adults) in Austria, Ireland, Norway (SC) Updated 13 Feb 2019
20 Dec 2018 Trial Update Sanofi plans a phase III trial for Asthma in January 2019 (NCT03782532) Updated 04 Apr 2019
17 Dec 2018 Phase Change - III Regeneron initiates phase-III clinical trials in Atopic dermatitis (Monotherapy, In adults) in China (SC) (NCT03912259) Updated 17 Apr 2019
10 Dec 2018 Phase Change - II Phase-II clinical trials in Urticaria (Treatment-resistant) in Germany (SC) (NCT03749148) (EudraCT2017-001262-25) Updated 13 Feb 2019
21 Nov 2018 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In adults) in United Kingdom, Finland (SC) before May 2019 [131] Updated 29 May 2019
21 Nov 2018 Phase Change - Marketed Launched for Atopic dermatitis (Monotherapy, In adults) in Finland, United Kingdom (SC) before May 2019 [131] Updated 29 May 2019
16 Nov 2018 Trial Update Regeneron Pharmaceuticals and Sanofi completes the SINUS-52 phase III trial in Rhinosinusitis in the US, Canada, Japan Russia, Portugal, Chile, Australia, Spain, Sweden Belgium (SC) (NCT02898454) Updated 05 Dec 2018
12 Nov 2018 Phase Change - II Phase-II clinical trials in Atopic dermatitis (Combination therapy) in USA (SC) (NCT03736967) Updated 07 Jan 2019
06 Nov 2018 Phase Change - Preregistration Preregistration for Atopic dermatitis (In adolescents) in European Union (SC) [40] Updated 17 Nov 2018
06 Nov 2018 Phase Change - Preregistration Preregistration for Atopic dermatitis (In adolescents, In children, Monotherapy) in USA (SC) [31] Updated 13 Nov 2018
06 Nov 2018 Regulatory Status Dupilumab receives priority review status for Atopic dermatitis (Monotherapy, In children, In adolescents) in USA [31] Updated 13 Nov 2018
06 Nov 2018 Regulatory Status FDA assigns PDUFA action date of (11/03/2019) for dupilumab for Atopic dermatitis (Monotherapy, In children, In adolescents) [31] Updated 13 Nov 2018
06 Nov 2018 Regulatory Status The US FDA accepts sBLA for dupilumab for Atopic dermatitis (Monotherapy, In children, In adolescents) in USA for review in USA [31] Updated 13 Nov 2018
04 Nov 2018 Phase Change - II Phase-II clinical trials in Chronic-urticaria (In adults, In the elderly, Treatment-experienced) in Germany (SC) (EudraCT2017-004458-41) . Updated 21 Oct 2021
20 Oct 2018 Phase Change - Marketed Launched for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in USA (SC) [138] Updated 23 Oct 2018
19 Oct 2018 Phase Change - III Phase-III clinical trials in Eosinophilic oesophagitis in USA (SC) [138] Updated 23 Oct 2018
19 Oct 2018 Phase Change - Registered Registered for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in USA (SC) [138] Updated 23 Oct 2018
16 Oct 2018 Scientific Update Safety and efficacy data from the phase III SINUS-52 and SINUS-24 in Rhinosinusitis released by Regeneron Pharmaceuticals and Sanofi [323] Updated 22 Oct 2018
15 Oct 2018 Phase Change - II Phase-II clinical trials in Peanut hypersensitivity (In children, In adolescents) in USA (SC) (9251977; 9251697) Updated 23 Oct 2018
25 Sep 2018 Trial Update Regeneron Pharmaceuticals, Sanofi, and Aimmune Therapeutics plan a phase II trial for Peanut hypersensitivity (Adjunctive therapy, In children, In adolescents) (NCT03682770) Updated 22 Oct 2018
24 Sep 2018 Phase Change - III Phase-III clinical trials in Eosinophilic oesophagitis (In adolescents, In adults) in Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom (SC) after September 2018 (NCT03633617) (EudraCT2018-000844-25) Updated 01 Mar 2022
24 Sep 2018 Trial Update Regeneron Pharmaceuticals and Sanofi initiates enrolment in a phase III trial for Eosinophilic oesophagitis in USA (NCT03633617) Updated 19 Nov 2018
17 Sep 2018 Scientific Update Updated efficacy data from a phase III trial in adolescent patients with moderate-to-severe atopic dermatitis released by Sanofi [99] Updated 19 Sep 2018
15 Sep 2018 Regulatory Status Regeneron/Sanofi announces intention to submit regulatory applications for Atopic Dermatitis for adolescents [98] Updated 19 Sep 2018
15 Sep 2018 Scientific Update Efficacy data from a phase III trial in Atopic dermatitis released by Regeneron [98] Updated 19 Sep 2018
30 Aug 2018 Trial Update Sanofi in collaboration with Regeneron initiates enrolment in a phase III trial for Asthma in USA, France, the Netherlands, Germany, Belgium (NCT03620747) Updated 17 Oct 2018
02 Aug 2018 Regulatory Status Regeneron announces intention to submit MAA to the EMA for Atopic dermatitis (In adolescents) in 2018 [370] Updated 17 Nov 2018
31 Jul 2018 Regulatory Status Sanofi announces intention to submit regulatory submission for Eosinophilic oesophagitis in 2022 [371] Updated 07 Apr 2022
31 Jul 2018 Regulatory Status Sanofi expects US FDA regulatory decision in Asthma (In Adult, In adolescent patients) in Q4 of 2018 [371] Updated 04 Apr 2019
31 Jul 2018 Regulatory Status Sanofi announces intention to submit regulatory submission for Asthma (In children) in 2022 [371] Updated 03 Aug 2018
26 Jul 2018 Trial Update Sanofi-aventis plans a long term phase III safety trial for Asthma in France, Argentina, Belgium, Canada, France, Germany, Israel, Japan, Netherlands, South Africa and USA (EudraCT2017-002134-23) Updated 10 Jul 2019
10 Jul 2018 Regulatory Status The Canadian Agency for Drugs and Technologies in Health (CADTH) does not recommend to reimburse dupilumab for Atopic dermatitis in Canada [49] Updated 13 Jul 2018
05 Jul 2018 Trial Update Sanofi-Aventis completes a phase III trial in Rhinosinusitis(Adjunctive treatment) in USA, Bulgaria, Czech Republic, France, Germany, Romania, Poland, Russia, Netherlands, Italy, Ukraine, United Kingdom and Hungary (SC) (NCT02912468) Updated 31 Aug 2018
05 Jul 2018 Scientific Update Updated safety and efficacy data from the phase III LIBERTY ASTHMA VENTURE trial in Asthma presented at 114th International Conference of the American Thoracic Society (ATS-2018) [203] Updated 05 Jul 2018
22 Jun 2018 Regulatory Status The National Institute for Health and Care Excellence (NICE) is expected to provide final Technology Appraisal Guidance (TAG) for dupilumab for Atopic dermatitis in England on 1 August 2018 [372] Updated 26 Jun 2018
22 Jun 2018 Regulatory Status The National Institute for Health and Care Excellence (NICE) recommends dupilumab in Final Appraisal Determination (FAD) for Atopic dermatitis in England [372] Updated 26 Jun 2018
22 Jun 2018 Regulatory Status The Scottish Medicines Consortium (SMC) is expected to provide recommendation for dupilumab for Atopic dermatitis in Scotland in the fourth quarter of 2018 [372] Updated 26 Jun 2018
21 Jun 2018 Phase Change - III Phase-III clinical trials in Asthma (In children) in Japan (SC) (NCT03560466) Updated 09 May 2023
21 Jun 2018 Trial Update Regeneron Pharmaceuticals and Sanofi initiates the phase III Liberty Asthma Excursion trial for Asthma (In children) in USA (SC) (NCT03560466) Updated 27 Jun 2018
14 Jun 2018 Phase Change - II Phase-II clinical trials in Grass pollen hypersensitivity (Adjunctive treatment) in USA (SC) (NCT03558997) Updated 03 Jul 2018
04 Jun 2018 Trial Update Regeneron Pharmaceuticals and Sanofi completes a phase III trial in Atopic dermatitis (Monotherapy, In children,In adolescents) in Canada, USA (SC) (NCT03054428) Updated 20 Aug 2018
16 May 2018 Regulatory Status Sanofi and Regeneron announce intention to submit sBLA to the US FDA for Atopic dermatitis (In adolescents) in the third quarter of 2018 [100] Updated 04 Apr 2019
16 May 2018 Scientific Update Interim efficacy and adverse events data from a phase III trial in Atopic dermatitis (In adolescents) released by Sanofi [100] Updated 21 May 2018
10 May 2018 Trial Update Sanofi-aventis plans the Liberty Asthma Excursion phase III trial for Asthma in Argentina, Australia, Brazil, Canada, Chile, Colombia, Hungary, Italy, Lithuania, Mexico, Poland, Romania, Russia, South Africa, Spain, Turkey, Ukraine, USA , (EudraCT2017-003317-25 ) Updated 27 Jun 2018
03 May 2018 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In adults) in Japan (SC) [46] Updated 10 May 2018
03 May 2018 Phase Change - Marketed Launched for Atopic dermatitis (Monotherapy, In adults) in Japan (SC) [46] Updated 10 May 2018
27 Apr 2018 Phase Change - Preregistration Preregistration for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in Japan (SC), before April 2018 [140] Updated 07 May 2018
03 Apr 2018 Regulatory Status The National Institute for Health and Care Excellence (NICE) issued a draft guidance not recommending dupilumab for the treatment of Atopic dermatitis in England [51] Updated 09 Apr 2018
03 Apr 2018 Phase Change - Preregistration Preregistration for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in European Union (SC) [134] Updated 04 Apr 2018
03 Apr 2018 Regulatory Status The EMA accepts an application for dupilumab for Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) for review [134] Updated 04 Apr 2018
30 Mar 2018 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In adults) in Denmark, Netherlands (SC) [23] Updated 04 May 2018
30 Mar 2018 Phase Change - Marketed Launched for Atopic dermatitis (Monotherapy, In adults) in Denmark, Netherlands (SC) [23] Updated 04 May 2018
12 Mar 2018 Phase Change - II Phase-II clinical trials in Asthma (Combination therapy, Treatment-experienced) in USA, Argentina, Chile, Mexico, Poland, Russia, Turkey and Ukraine (SC) (NCT03387852) Updated 25 Jun 2019
12 Mar 2018 Phase Change - II Phase-II clinical trials in Asthma (Monotherapy, Treatment-experienced) in USA, Argentina, Chile, Mexico, Poland, Russia, Turkey and Ukraine (SC) (NCT03387852) Updated 25 Jun 2019
12 Mar 2018 Trial Update Sanofi initiates a phase II trial in Asthma in USA (SC) (NCT03387852) Updated 31 Mar 2018
02 Mar 2018 Regulatory Status FDA assigns PDUFA action date of 20/10/2018 for dupilumab for Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) [139] Updated 23 Oct 2018
02 Mar 2018 Regulatory Status The US FDA accepts sBLA for dupilumab for Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) for review [139] Updated 06 Mar 2018
12 Feb 2018 Trial Update Regeneron completes a phase I trial in Atopic dermatitis (In adolescents, In adults, In the elderly) in USA (SC) (NCT03050151) Updated 13 Aug 2018
08 Feb 2018 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In adults, Treatment-experienced) in Canada (SC) [41] Updated 09 Feb 2018
08 Feb 2018 Phase Change - Marketed Launched for Atopic dermatitis (Monotherapy, In adults, Treatment-experienced) in Canada (SC) [41] Updated 09 Feb 2018
07 Feb 2018 Regulatory Status Sanofi announces intention to submit marketing authorisation application in European Union for Asthma (In adolescents, In adults) in second quarter of 2018 [373] Updated 09 Feb 2018
29 Jan 2018 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, Monotherapy) in Australia (SC) [44] Updated 01 Feb 2018
22 Jan 2018 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, In adults) in Japan (SC) [47] Updated 24 Jan 2018
22 Jan 2018 Phase Change - Registered Registered for Atopic dermatitis (Monotherapy, In adults) in Japan (SC) [47] Updated 24 Jan 2018
03 Jan 2018 Trial Update Sanofi completes the phase II EXPEDITION trial in Asthma in Canada, Denmark, Germany, Sweden, United Kingdom and USA (NCT02573233) Updated 09 Feb 2018
31 Dec 2017 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In adults) in Germany (SC) [23] Updated 04 May 2018
31 Dec 2017 Phase Change - Marketed Launched for Atopic dermatitis (Monotherapy, In adults) in Germany (SC) [23] Updated 04 May 2018
19 Dec 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Adjunctive treatment, In children) in United Kingdom, Poland, Germany, Czech Republic, Canada (SC) after November 2017 (NCT03345914) Updated 08 Aug 2019
19 Dec 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In children, Adjunctive treatment) in USA (SC) (NCT03345914) Updated 21 Dec 2017
13 Dec 2017 Regulatory Status Regeneron announces intention to submit sBLA to the US FDA for Rhinosinusitis (In adults) in 2019 [374] Updated 30 May 2023
13 Dec 2017 Trial Update Regeneron plans pivotal phase II/III trials for Chronic obstructive pulmonary disease in 2018 [374] Updated 13 Mar 2019
13 Dec 2017 Trial Update Regeneron plans a phase III trial for Eosinophilic oesophagitis (NCT03633617) [374] Updated 19 Nov 2018
13 Dec 2017 Trial Update Regeneron plans a phase II trial for Grass pollen hypersensitivity (Adjunctive treatment) in 2018 (SC) (NCT03558997) [374] Updated 03 Jul 2018
13 Dec 2017 Trial Update Regeneron plans clinical trials for Inflammation (comorbid allergic inflammatory conditions) in 2018 [374] Updated 19 Dec 2017
04 Dec 2017 Scientific Update Updated efficacy data from the SOLO 1, SOLO 2 and CHRONOS phase III trials in Atopic dermatitis released by Sanofi [43] Updated 06 Dec 2017
01 Dec 2017 Phase Change - Preregistration Preregistration for Asthma (Adjunctive treatment, In adolescents, In the elderly, In adults) in USA (SC) [47] Updated 24 Jan 2018
30 Nov 2017 Phase Change - II/III Phase-II/III clinical trials in Atopic dermatitis(In children, In infants, Treatment-experienced) in Germany, Poland, United Kingdom, USA (SC) (NCT03346434) [103] Updated 22 Feb 2018
30 Nov 2017 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, In adults, Treatment-experienced) in Canada (SC) [43] Updated 06 Dec 2017
30 Nov 2017 Phase Change - Registered Registered for Atopic dermatitis (Monotherapy, In adults, Treatment-experienced) in Canada (SC) [43] Updated 06 Dec 2017
23 Nov 2017 Trial Update Regeneron Pharmaceuticals completes phase III LIBERTY ASTHMA QUEST trial for Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) in USA, Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, South Africa, Spain, Taiwan, Turkey, Ukraine, South Korea and United kingdom (NCT02414854) Updated 07 May 2021
13 Nov 2017 Trial Update Sanofi completes the VENTURE trial in Asthma in US, Argentina, Belgium, Brazil, Canada, Chile, Colombia, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russia, Spain and Ukraine (SC) (NCT02528214) Updated 01 Dec 2017
02 Nov 2017 Regulatory Status Regeneron Pharmaceuticals and Sanofi intend to launch dupilumab for Atopic dermatitis in Germany by the end of 2017 [375] Updated 04 Apr 2018
31 Oct 2017 Scientific Update Updated efficacy data from the phase III LIBERTY ASTHMA VENTURE trial in Asthma released by Regeneron Pharmaceuticals [200] Updated 08 Nov 2017
31 Oct 2017 Scientific Update Safety and efficacy data from the phase III LIBERTY ASTHMA VENTURE trial in Asthma released by Regeneron Pharmaceuticals [201] Updated 07 Nov 2017
16 Oct 2017 Regulatory Status Dupilumab - Regeneron/Sanofi receives Orphan Drug status for Eosinophilic oesophagitis in USA [268] Updated 20 Oct 2017
16 Oct 2017 Scientific Update Positive efficacy and safety data from a phase II trial in Eosinophilic oesophagitis released by Sanofi and Regeneron Pharmaceuticals [268] Updated 20 Oct 2017
28 Sep 2017 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, In adults) in Liechtenstein, Iceland, Norway (SC) [37] Updated 13 Feb 2019
28 Sep 2017 Phase Change - Registered Registered for Atopic dermatitis (Monotherapy, In adults) in Liechtenstein, Iceland, Norway (SC) [37] Updated 13 Feb 2019
28 Sep 2017 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, In adults) in European Union (SC) [37] Updated 03 Oct 2017
28 Sep 2017 Phase Change - Registered Registered for Atopic dermatitis (Monotherapy, In adults) in European Union (SC) [37] Updated 03 Oct 2017
28 Sep 2017 Scientific Update Integrated adverse events data from SOLO 1, SOLO 2, CHRONOS, SOLO-CONTINUE and CAFÉ phase III trials in Atopic dermatitis released by Sanofi and Regeneron [37] Updated 03 Oct 2017
16 Sep 2017 Scientific Update Updated adverse events and efficacy data from the phase III CAFE trial in Atopic dermatitis released by Regeneron Pharmaceuticals [74] [73] Updated 20 Sep 2017
11 Sep 2017 Scientific Update Efficacy and safety data from the phase III LIBERTY ASTHMA QUEST trial in Asthma released by Sanofi and Regeneron Pharmaceuticals [173] Updated 12 Sep 2017
03 Aug 2017 Regulatory Status Regeneron Pharmaceuticals announces intention to submit a sBLA to US FDA for Asthma (In adolescents, In adults) (uncontrolled asthma) by the end of 2017 [376] Updated 24 Jan 2018
03 Aug 2017 Trial Update Regeneron Pharmaceuticals plans a phase III trial for Atopic dermatitis (In children, Combination therapy) in December 2017 in USA (SC) (NCT03345914) [376] Updated 21 Dec 2017
21 Jul 2017 Regulatory Status Committee for Medicinal Products for Human Use (CHMP) of EMA recommends approval of dupilumab for Atopic dermatitis (Monotherapy, Adjunctive therapy, In adults) in European Union [38] Updated 25 Jul 2017
10 Jul 2017 Trial Update Regeneron Pharmaceuticals and Sanofi completes a phase II trial in Eosinophilic oesophagitis (Monotherapy) in USA (SC) (NCT02379052) Updated 30 Oct 2017
21 Apr 2017 Phase Change - III Phase-III clinical trials in Asthma (In children, Adjunctive treatment) in Ukraine, Turkey, Spain, South Africa, Russia, Romania, Poland, Mexico, Lithuania, Italy, Hungary, Colombia, Chile, Canada, Brazil, Australia and Argentina (SC) (NCT02948959) (EudraCT2016-001607-23) Updated 24 Sep 2020
20 Apr 2017 Trial Update Regeneron Pharmaceuticals and Sanofi plans a phase I trial for Allergic asthma (Monotherapy, Combination therapy) (NCT03112577) Updated 22 May 2017
07 Apr 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy, In children, In adolescents) in Canada (SC) after April 2017 (NCT03054428) Updated 21 May 2018
07 Apr 2017 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy, In children, In adolescents) in USA (SC) (NCT03054428) Updated 10 May 2017
01 Apr 2017 Phase Change - I Phase-I clinical trials in Allergic asthma (Combination therapy) in United Kingdom (SC) (NCT03112577) Updated 28 Jan 2020
01 Apr 2017 Phase Change - I Phase-I clinical trials in Allergic asthma (Monotherapy) in United Kingdom (SC) (NCT03112577) Updated 28 Jan 2020
01 Apr 2017 Phase Change - I Phase-I clinical trials in Allergic asthma (Combination therapy) in USA (SC) (NCT03112577) Updated 22 May 2017
01 Apr 2017 Phase Change - I Phase-I clinical trials in Allergic asthma (Monotherapy) in USA (SC) (NCT03112577) Updated 22 May 2017
31 Mar 2017 Phase Change - Marketed Launched for Atopic dermatitis (Adjunctive treatment, In adults) in USA (SC) - First global launch [25] Updated 11 May 2017
31 Mar 2017 Phase Change - Marketed Launched for Atopic dermatitis (Monotherapy, In adults) in USA (SC) - First global launch [25] Updated 11 May 2017
30 Mar 2017 Phase Change - III Phase-III clinical trials in Asthma (In children, Adjunctive treatment) in USA (SC) (NCT02948959) Updated 18 Apr 2017
30 Mar 2017 Phase Change - Discontinued(I) Discontinued - Phase-I for Atopic dermatitis (In volunteers) in USA (IV) Updated 30 Mar 2017
28 Mar 2017 Phase Change - Registered Registered for Atopic dermatitis (Adjunctive treatment, In adults) in USA (SC) - First global approval [26] Updated 29 Mar 2017
28 Mar 2017 Phase Change - Registered Registered for Atopic dermatitis (Monotherapy, In adults) in USA (SC) - First global approval [26] Updated 29 Mar 2017
14 Mar 2017 Regulatory Status Dupilumab granted positive scientific opinion through the Early Access to Medicines Scheme (EAMS) by Medicines and Healthcare Products Regulatory Agency (MHRA) in United Kingdom [52] Updated 16 Mar 2017
09 Mar 2017 Trial Update Regeneron initiates a phase I trial in Atopic dermatitis (In adolescents, In adults, In the elderly) in USA (SC) (NCT03050151) Updated 10 May 2017
06 Mar 2017 Scientific Update Safety and efficacy data from phase III trial in Atopic dermatitis presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2017) [89] Updated 22 Mar 2017
04 Mar 2017 Scientific Update Updated efficacy data from a phase III trial in Atopic dermatitis presented at the Annual Meeting of the American Academy of Dermatology (AAD-2017) [81] Updated 07 Mar 2017
01 Mar 2017 Trial Update Regeneron completes the phase III CAFE trial for Atopic dermatitis (Monotherapy, In inadequately controlled severe disease) in Poland, Austria, Belgium, Germany, Russia, Spain, Netherlands, Ireland, Russia, Slovakia and United Kingdom (SC) (NCT02755649) Updated 26 May 2017
17 Feb 2017 Trial Update Regeneron plans phase III trial in Atopic dermatitis (In chlidren) (NCT03054428) [101] Updated 17 Feb 2017
10 Feb 2017 Regulatory Status Regeneron announces intention to submit sBLA to the USFDA for dupilumab for Asthma [101] Updated 16 Feb 2017
10 Feb 2017 Trial Update Regeneron plans a phase II trial in food allergies [101] Updated 16 Feb 2017
10 Feb 2017 Trial Update Regeneron plans phase III trials in Asthma (In chlidren) [101] Updated 16 Feb 2017
09 Feb 2017 Trial Update Regeneron completes enrolment in the phase III LIBERTY AD CAFÉ trial for Atopic dermatitis before January 2016 (Regeneron's Form 10-K, February 2017) Updated 08 May 2017
08 Feb 2017 Regulatory Status Sanofi announces intention to submit a regulatory application for Atopic dermatitis in Japan in first quarter of 2017 (Sanofi pipeline, February 2017) Updated 15 Feb 2017
08 Feb 2017 Trial Update Regeneron and Sanofi plan a phase I trial for Atopic dermatitis (In adolescents, In adults) in USA (NCT03050151) Updated 14 Feb 2017
08 Dec 2016 Active Status Review Dupilumab is still in phase II trials for Eosinophilic oesophagitis in USA [39] Updated 14 Dec 2016
08 Dec 2016 Phase Change - Preregistration Preregistration for Atopic dermatitis (Adjunctive therapy, In adults) in European Union (SC) [39] Updated 14 Dec 2016
08 Dec 2016 Phase Change - Preregistration Preregistration for Atopic dermatitis (Monotherapy, In adults) in European Union (SC) [39] Updated 14 Dec 2016
01 Dec 2016 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in Romania (SC) (NCT02912468) after December 2016 Updated 31 Aug 2018
01 Dec 2016 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in Poland, Germany, France, Czech Republic, Bulgaria (SC) (NCT02912468) Updated 30 Mar 2017
01 Dec 2016 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in Italy, Ukraine, United Kingdom (SC) after December 2016 (NCT02912468) Updated 14 Feb 2017
01 Dec 2016 Trial Update Sanofi-Aventis initiates a phase III trial in Rhinosinusitis (Adjunctive treatment) in USA (SC) (NCT02912468) Updated 14 Feb 2017
01 Dec 2016 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in Netherlands (SC) after December 2016 (NCT02912468) Updated 04 Jan 2017
01 Dec 2016 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in Hungary (SC) (NCT02912468) Updated 15 Dec 2016
28 Nov 2016 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in Argentina, Israel, Mexico, Turkey (SC) (NCT02898454) (EudraCT2015-001314-10) Updated 05 Dec 2018
01 Nov 2016 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in Russia, Portugal, Chile, Australia, Spain, Sweden and Belgium (SC) (NCT02898454) Updated 30 Mar 2017
01 Nov 2016 Phase Change - III Phase-III clinical trials in Rhinosinusitis (Adjunctive treatment) in USA, Canada and Japan (SC) (NCT02898454) Updated 14 Dec 2016
31 Oct 2016 Trial Update Regeneron Pharmaceuticals completes enrolment in the LIBERTY ASTHMA QUEST trial for Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) in USA, Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Italy, Japan, Mexico, Poland, Russia, South Africa, Spain, Taiwan, Turkey, Ukraine and United kingdom, South Korea, Hungary (NCT02414854) Updated 28 Nov 2016
31 Oct 2016 Regulatory Status Dupilumab receives Breakthrough Therapy status for Atopic dermatitis (In adolescents, In children, In infants) in USA [53] Updated 09 Nov 2016
27 Oct 2016 Trial Update Regeneron Pharmaceuticals and Sanofi plan the phase III Liberty Asthma Voyage trial for Asthma (Adjunctive treatment, In adolescents, In children) in USA (SC) (NCT02948959) Updated 08 Nov 2016
01 Oct 2016 Trial Update Regeneron Pharmaceuticals completes the phase III Liberty AD Solo-Continue trial in Atopic dermatitis (Monotherapy) in Lithuania, Estonia, Germany, Finland, Sweden, United Kingdom, Denmark, Spain, Bulgaria, Poland and Italy (NCT02395133) Updated 13 Jun 2017
01 Oct 2016 Phase Change - Clinical Clinical trials in Atopic dermatitis (In adolescents, In children, In infants) in USA (SC) before October 2016 [53] Updated 29 Mar 2017
01 Oct 2016 Trial Update Regeneron completes the phase III LIBERTY AD CHRONOS trial in Atopic dermatitis (Adjunctive therapy) in Germany, Netherlands, Belgium, Hungary, Latvia, Poland, Spain, United Kingdom, Czech Republic, France, Italy, Romania, USA, Canada, Australia, New Zealand, Japan, South Korea, Taiwan and Russia (SC) (NCT02260986) Updated 16 Nov 2016
01 Oct 2016 Scientific Update Therapeutic trials and adverse events data from the phase III LIBERTY AD SOLO 1 and SOLO 2 trials released by Regeneron and Sanofi [79] Updated 04 Oct 2016
26 Sep 2016 Regulatory Status Dupilumab receives priority review status for Atopic dermatitis in USA [28] Updated 28 Sep 2016
26 Sep 2016 Regulatory Status Planned Prescription Drug User Fee Act (PDUFA) date for Atopic dermatitis (Combination therapy) in USA (SC) is 2017-03-29 [28] Updated 28 Sep 2016
26 Sep 2016 Regulatory Status US FDA accepts BLA for dupilumab for Atopic dermatitis for review [28] Updated 28 Sep 2016
08 Sep 2016 Trial Update Sanofi-Aventis plans a phase III trial for Rhinosinusitis (Adjunctive treatment) in USA (SC) (NCT02898454) Updated 21 Sep 2016
03 Sep 2016 Scientific Update Updated results from the phase IIa trial in Rhinosinusitis presented at the 26th Annual Congress of the European Respiratory Society (ERS-2016) Updated 04 Jan 2017
04 Aug 2016 Phase Change - Preregistration Preregistration for Atopic dermatitis (Monotherapy, In adults) in USA (SC) [29] Updated 14 Dec 2016
04 Aug 2016 Phase Change - Preregistration Preregistration for Atopic dermatitis (Adjunctive therapy; In adults) in USA (SC) [29] Updated 09 Aug 2016
21 Jul 2016 Trial Update Sanofi-Aventis plans a phase III trial for Rhinosinusitis (Adjunctive treatment) in United Kingdom (UKCRN30597) Updated 27 Jul 2016
01 Jul 2016 Trial Update Regeneron Pharmaceuticals completes a phase I trial in Atopic dermatitis in USA (NCT02647086) Updated 30 Aug 2016
06 Jun 2016 Regulatory Status Regeneron and Sanofi announces intention to submit NDA to the US FDA in the third quarter of 2016 [83] Updated 16 Jun 2016
06 Jun 2016 Scientific Update Efficacy and adverse events data from the phase III LIBERTY AD CHRONOS trial in Atopic dermatitis (Adjunctive therapy) released by Regeneron and Sanofi [83] Updated 16 Jun 2016
08 Apr 2016 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy; In inadequately controlled severe disease) in Ireland (SC) after April 2016 (EudraCT2015-002653-35) Updated 16 Jun 2016
01 Apr 2016 Scientific Update Interim adverse events and efficacy data from two phase III trials (SOLO 1 and SOLO 2) in Atopic dermatitis released by Regeneron Pharmaceuticals [377] Updated 21 Apr 2016
04 Mar 2016 Scientific Update Interim efficacy data from a phase IIb trial in Asthma presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2016) [378] Updated 29 Mar 2016
01 Mar 2016 Trial Update Regeneron Pharmaceuticals completes a phase II trial for Atopic dermatits (In children, In adolescents) in Canada, Czech Republic, Germany, Hungary, Poland and United Kingdom (NCT02407756) Updated 01 Sep 2016
01 Feb 2016 Trial Update Regeneron Pharmaceuticals completes a phase III trial in Atopic dermatitis (Monotherapy) in USA, Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Japan, Singapore and Spain (SC) (NCT02277743) Updated 28 Mar 2016
27 Jan 2016 Phase Change - II Phase-II clinical trials in Asthma (Adjunctive treatment) in Denmark, Sweden, Canada, Germany, United Kingdom, USA (SC) (NCT02573233) Updated 09 Feb 2018
01 Jan 2016 Trial Update Regeneron initiates enrolment in the phase III LIBERTY AD CAFÉ trial for Atopic dermatitis (Regeneron's Form 10-K, February 2017) Updated 08 May 2017
01 Jan 2016 Trial Update Regeneron Pharmaceuticals completes a phase III trial in Atopic dermatitis (Monotherapy) in USA, France, Canada, Germany, Hong Kong, Italy, Lithuania, Poland, South Korea, Sweden and the UK (NCT02277769) Updated 10 Mar 2016
30 Dec 2015 Regulatory Status Medicines and Healthcare Products Regulatory Agency (MHRA) granted a Promising Innovative Medicine (PIM) status for dupilumab for the treatment of severe Atopic dermatitis [51] Updated 09 Apr 2018
16 Dec 2015 Trial Update Regeneron Pharmaceuticals initiates a phase III trial for Atopic dermatitis (Monotherapy) in Poland (SC) (EudraCT2015-002653-35) Updated 16 Dec 2015
01 Dec 2015 Trial Update Regeneron Pharmaceuticals initiates a phase I trial in Atopic dermatitis in USA (NCT02647086) Updated 08 Jan 2016
01 Nov 2015 Trial Update Regeneron initiates enrolment in a phase III trial for Atopic dermatitis (Monotherapy; In inadequately controlled severe disease) in United Kingdom (SC) after November 2015 (EudraCT2015-002653-35) Updated 16 Jun 2016
01 Nov 2015 Trial Update Regeneron Pharmaceuticals initiates a phase III trial for Atopic dermatitis (Monotherapy) in Austria, Belgium, Netherlands and Slovakia after November 2015 (SC) (EudraCT2015-002653-35) Updated 10 Mar 2016
26 Oct 2015 Phase Change - III Phase-III clinical trials in Asthma (In adolescents, In adults, Adjunctive treatment) in United Kingdom (SC) prior to October 2015 (UKCRN 18537) Updated 26 Oct 2015
15 Oct 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In infants, In adolescents, In children) in Canada (SC) (NCT02612454; EudraCT2015-001396-40) Updated 17 May 2023
15 Oct 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In infants, In children, In adolescents) in USA (SC) (NCT02612454; EudraCT2015-001396-40) Updated 17 May 2023
08 Oct 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In children) in Germany (SC) (EudraCT2015-001396-40) Updated 17 Nov 2018
08 Oct 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis ( In children) in United Kingdom, Czech Republic (SC) (EudraCT2015-001396-40) Updated 29 Mar 2017
08 Oct 2015 Trial Update Sanofi plans the phase II EXPEDITION trial for Asthma (Adjunctive therapy) in USA and Canada (SC) (NCT02573233) Updated 14 Oct 2015
08 Oct 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis ( In children) in Poland (SC) Updated 09 Oct 2015
08 Oct 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis (In children) in Hungary (SC) Updated 09 Oct 2015
01 Oct 2015 Trial Update Sanofi, in collaboration with Regeneron, initiates enrolment in a phase III VENTURE trial in steroid-dependent asthma in USA (NCT02528214) Updated 09 Nov 2015
30 Sep 2015 Trial Update Regeneron Pharmaceuticals completes enrolment in its phase IIa trial for Atopic dermatits (In children, In adolescents) in Canada, Czech Republic, Germany, Hungary, Poland and United Kingdom [111] , NCT02407756) before September 2015 Updated 09 Nov 2015
01 Sep 2015 Trial Update Regeneron Pharmaceuticals and Sanofi complete a phase II trial in Atopic dermatitis in USA (NCT02210780) Updated 04 Nov 2015
24 Aug 2015 Trial Update Sanofi and Regeneron plan the phase III VENTURE trial for Asthma (Adjunctive therapy) in USA (NCT02528214) Updated 24 Aug 2015
09 Aug 2015 Phase Change - III Phase-III clinical trials in Asthma (Adjunctive therapy) in Ukraine (SC) prior to August 2015 Updated 09 Aug 2015
09 Aug 2015 Trial Update Regeneron Pharmaceuticals completes enrolment in the phase III SOLO 1 trial for Atopic dermatitis (Monotherapy) in the USA, Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Japan, Singapore and Spain (NCT02277743) prior to August 2015 Updated 09 Aug 2015
09 Aug 2015 Trial Update Regeneron Pharmaceuticals completes enrolment in the phase III SOLO 2 trial for Atopic dermatitis (Monotherapy) in the USA, France, Canada, Germany, Hong Kong, Italy, Lithuania, Poland, South Korea, Sweden and the UK (NCT02277769) prior to August 2015 Updated 09 Aug 2015
31 Jul 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy) in Singapore, Finland, Denmark and Bulgaria (SC) prior to July 2015 Updated 09 Aug 2015
22 Jun 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy) in Poland, Hong Kong, France (SC) prior to June 2015 Updated 09 Aug 2015
18 May 2015 Scientific Update Efficacy and adverse events data from a phase IIb trial in Asthma presented at the International Conference of the American Thoracic Society (ATC-2015) [215] Updated 30 Jun 2015
08 Apr 2015 Trial Update Sanofi and Regeneron plans a phase III trial for Asthma in USA, Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Italy, Japan, Mexico, Poland, Russia, South Africa, Spain, Taiwan, Turkey, Ukraine and United Kingdom (NCT02414854, EudraCT2014-004940-36) Updated 16 Apr 2015
01 Apr 2015 Phase Change - III Phase-III clinical trials in Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) in United Kingdom, Taiwan, Hungary, Germany, Colombia, Brazil, South Korea(SC) (NCT02414854) Updated 30 Mar 2017
01 Apr 2015 Phase Change - III Phase-III clinical trials in Asthma (Adjunctive therapy) in Canada and USA (SC) Updated 09 Aug 2015
01 Apr 2015 Trial Update Regeneron Pharmaceuticals and Sanofi complete a phase IIb trial in Asthma (Adjunctive therapy) in USA, Australia, Argentina, Chile, Japan, France, Mexico, South Korea, New Zealand, Poland, South Africa, Russia, Turkey, Ukraine, Italy and Spain (NCT01854047) Updated 28 May 2015
30 Mar 2015 Trial Update Sanofi completes a phase I trial in volunteers in USA (NCT05976373) Updated 08 Aug 2023
24 Mar 2015 Trial Update Regeneron Pharmaceuticals initiates enrolment in the phase III Liberty AD Solo - Continue trial for Atopic dermatitis in Germany (SC) (EudraCT2014-003384-38) Updated 30 Apr 2015
24 Mar 2015 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy) in Lithuania (SC) (NCT02395133; EudraCT2014-003384-38) Updated 12 Mar 2015
11 Feb 2015 Phase Change - II Phase-II clinical trials in Atopic dermatitis (In adolescents, In children) in United Kingdom, Germany, Czech Republic (SC) after February 2015 Updated 09 Nov 2015
11 Feb 2015 Phase Change - II Phase-II clinical trials in Atopic dermatitis (In adolescents, In children) in Canada and Poland (SC) (NCT02407756, EudraCT2014-003263-37) after February 2015 Updated 16 Apr 2015
11 Feb 2015 Phase Change - II Phase-II clinical trials in Atopic dermatitis (In adolescents, In children) in Hungary (SC) (EudraCT2014-003263-37) Updated 18 Feb 2015
05 Jan 2015 Trial Update Sanofi initiates a phase I trial in volunteers in USA (NCT05976373) Updated 08 Aug 2023
01 Jan 2015 Trial Update Regeneron and Sanofi complete a phase II trial for Atopic dermatitis in USA and Canada (NCT01979016) Updated 28 May 2015
01 Jan 2015 Phase Change - II Phase-II clinical trials in Eosinophilic oesophagitis (Monotherapy) in USA (SC) (NCT02379052) Updated 23 Feb 2015
31 Dec 2014 Scientific Update Efficacy and adverse events data from a phase IIa trial in Atopic dermatitis released by Regeneron before December 2014 (Regeneron, Form 10-K, February 2015) Updated 27 Mar 2015
20 Nov 2014 Regulatory Status Dupilumab receives Breakthrough Therapy status for Atopic dermatitis (In adults) in USA [54] Updated 16 Jun 2016
20 Nov 2014 Regulatory Status Dupilumab receives breakthrough therapy designation for Atopic dermatitis in USA [54] Updated 22 Nov 2014
19 Nov 2014 Trial Update Regeneron Pharmaceuticals plans the phase III SOLO 2 trial for Atopic dermatitis (Monotherapy) in Canada, France, Germany, Hong Kong, Italy, South Korea, Lithuania, Poland, Sweden and United Kingdom (NCT02277769) Updated 19 Nov 2014
11 Nov 2014 Scientific Update Top-line efficacy & adverse events data from a phase IIb trial in Asthma released by Regeneron Pharmaceuticals & Sanofi [216] , [217] Updated 17 Nov 2014
06 Nov 2014 Trial Update Regeneron Pharmaceuticals plans a phase III trial for Atopic dermatitis (Monotherapy) in Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Japan, Singapore and Spain (NCT02277743) Updated 06 Nov 2014
01 Nov 2014 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy) in Italy, South Korea, Sweden and United Kingdom (SC) (NCT02277769) Updated 09 Jan 2015
01 Nov 2014 Trial Update Regeneron Pharmaceuticals and Sanofi initiates enrolment in the phase III SOLO 2 trial for Atopic dermatitis (Monotherapy) in USA (NCT02277769) Updated 09 Jan 2015
01 Nov 2014 Trial Update Sanofi and Regeneron Pharmaceuticals completes a phase II trial for Rhinosinusitis in USA, Belgium, Spain and Sweden (NCT01920893; EudraCT2013-001803-35) Updated 12 Dec 2014
13 Oct 2014 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Combination therapy) in USA, Canada, United Kingdom, France, Italy, Romania, Czech Republic, Australia, New Zealand, Japan, South Korea, Taiwan & Russia (SC) Updated 22 Oct 2014
01 Oct 2014 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy) in Estonia, Germany, Japan and Spain (SC) (NCT02277743) after October 2015 Updated 16 Apr 2015
01 Oct 2014 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy) in Canada (SC) (NCT02277743) Updated 09 Jan 2015
01 Oct 2014 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Monotherapy) in USA (SC) (NCT02277743) Updated 09 Jan 2015
30 Sep 2014 Scientific Update Top-line efficacy & adverse events data from a phase II trial in Rhinosinusitis released by Sanofi & Regeneron Pharmaceuticals [328] , [329] Updated 02 Oct 2014
16 Sep 2014 Phase Change - III Phase-III clinical trials in Atopic dermatitis in Netherlands (SC) before September 2014 Updated 16 Sep 2014
01 Sep 2014 Trial Update Regeneron & Sanofi complete a phase IIb trial in Atopic dermatitis in the US, Canada, Japan, Czech Republic, Hungary, Germany and Poland (NCT01859988) Updated 08 Oct 2014
01 Sep 2014 Phase Change - III Phase-III clinical trials in Asthma (Combination therapy) in South Korea and Argentina (SC) Updated 16 Sep 2014
05 Aug 2014 Phase Change - III Phase-III clinical trials in Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) in France, Spain, Italy and Poland (SC) (NCT02134028) Updated 15 Dec 2020
05 Aug 2014 Phase Change - II Phase-II clinical trials in Asthma (Combination therapy) in Argentina, Chile, South Korea, Mexico, New Zealand, Poland and Ukraine (SC) before August 2014 Updated 16 Sep 2014
05 Aug 2014 Trial Update Regeneron Pharmaceuticals and Sanofi complete enrolment in a phase IIb trial for Asthma (combination therapy) in USA, Australia, Argentina, Chile, Japan, France, Mexico, South Korea, New Zealand, Poland, South Africa, Russia, Turkey, Ukraine, Italy and Spain (NCT01854047) Updated 16 Sep 2014
05 Aug 2014 Trial Update Sanofi and Regeneron Pharmaceuticals complete enrolment in a phase II trial for Rhinosinusitis in USA, Belgium, Spain and Sweden (NCT01920893) Updated 16 Sep 2014
01 Aug 2014 Trial Update Regeneron Pharmaceuticals and Sanofi initiate a phase II trial for Atopic dermatitis in USA (SC) (NCT02210780) Updated 30 Sep 2014
21 Jul 2014 Phase Change - II/III Phase-II/III clinical trials in Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) in Sweden, Romania, Hungary, Belgium (SC) after July 2014 (NCT02134028; EudraCT2013-003856-19) Updated 23 Oct 2019
10 Jul 2014 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Combination therapy) in Belgium, Germany, Poland, Hungary, Netherlands, Latvia & Spain (SC) Updated 22 Oct 2014
09 Jul 2014 Scientific Update Efficacy and adverse events data from a phase IIb trial in Atopic dermatitis released by Regeneron and Sanofi [115] Updated 15 Jul 2014
01 Jul 2014 Phase Change - III Phase-III clinical trials in Asthma (Adjunctive treatment, In adolescents, In adults, In the elderly) in Netherlands, Poland, Mexico, Chile and Israel (SC) (NCT02134028) Updated 30 Mar 2017
01 Jul 2014 Phase Change - III Phase-III clinical trials in Asthma (Combination therapy) in Australia, Italy, Spain, France, Russia, South Africa, Turkey and Japan (SC) Updated 28 Aug 2014
06 May 2014 Phase Change - III Phase-III clinical trials in Atopic dermatitis in Hungary (SC) Updated 26 May 2014
30 Apr 2014 Trial Update Regeneron and Sanofi plans a phase III extension trial for Asthma in Australia (NCT02134028) Updated 23 May 2014
01 Mar 2014 Patent Information Sanofi has patent protection for dupilumab in USA, European Union and Japan Updated 17 Dec 2015
23 Jan 2014 Trial Update Regeneron & Sanofi complete enrolment in a phase IIb trial in Atopic dermatitis in the US, Canada, Japan, Czech Republic, Hungary, Germany and Poland (NCT01859988) Updated 17 Mar 2014
31 Dec 2013 Trial Update Regeneron & Sanofi initiate enrolment in a phase II trial for Atopic dermatitis in USA & Canada (NCT01979016) Updated 10 Mar 2014
02 Dec 2013 Phase Change - III Phase-III clinical trials in Atopic dermatitis in Germany (SC) (EudraCT2013-001449-15, NCT01949311) Updated 17 Dec 2013
01 Nov 2013 Trial Update Regeneron & Sanofi plan a phase II trial for Atopic dermatitis in USA and Canada (NCT01979016) Updated 18 Nov 2013
14 Oct 2013 Phase Change - II Phase-II clinical trials in Rhinosinusitis in USA (SC) Updated 30 Oct 2013
01 Oct 2013 Phase Change - III Phase-III clinical trials in Atopic dermatitis (Adjunctive treatment, In adults) in China (SC) (NCT01949311) Updated 30 Mar 2017
26 Sep 2013 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Japan & Canada (SC) (NCT01859988) Updated 30 Sep 2013
20 Sep 2013 Trial Update Regeneron & Sanofi plan a phase III extension trial for Atopic dermatitis in Canada, Japan, Czech Republic, France, Germany, Hungary, Poland, Australia & New Zealand (NCT01949311) Updated 26 Sep 2013
31 Aug 2013 Phase Change - II Phase-II clinical trials in Rhinosinusitis (combination therapy) in Belgium (SC) Updated 12 Sep 2013
14 Aug 2013 Phase Change - II Phase-II clinical trials in Asthma (combination therapy) in Australia, Italy and Spain (SC) Updated 14 Aug 2013
08 Aug 2013 Trial Update Sanofi and Regeneron plan a phase II trial for Rhinosinusitis in the US and Belgium (NCT01920893) Updated 14 Aug 2013
31 Jul 2013 Trial Update Regeneron & Sanofi complete a phase II trial for Atopic dermatitis in Czech Republic, France, Germany, Hungary & Poland (NCT01548404) Updated 10 Mar 2014
29 Jul 2013 Phase Change - II Phase-II clinical trials in Rhinosinusitis in Spain (SC) Updated 30 Oct 2013
29 Jul 2013 Phase Change - II Phase-II clinical trials in Rhinosinusitis (combination therapy) in Sweden (SC) Updated 12 Sep 2013
17 Jun 2013 Trial Update Regeneron & Sanofi initiate enrolment in a phase IIb trial for Asthma (combination therapy) in USA (NCT01854047) Updated 19 Jun 2013
21 May 2013 Trial Update Regeron and Sanofi initiates enrolment in a phase IIb trial for Atopic dermatitis in Czech Republic, Hungary, Germany and Poland (NCT01859988) after May 2013 Updated 08 Oct 2014
21 May 2013 Phase Change - II Phase-II clinical trials in Atopic dermatitis in USA (SC) (NCT01859988) Updated 14 Jun 2013
21 May 2013 Scientific Update Efficacy and adverse events data from a phase II trial in Asthma presented at the 109th International Conference of the American Thoracic Society (ATS-2013) [249] , [250] Updated 29 May 2013
15 Apr 2013 Trial Update Regeneron & Sanofi complete enrolment in a phase II trial for Atopic dermatitis in Czech Republic, France, Germany, Hungary & Poland (NCT01548404) Updated 24 Apr 2013
05 Mar 2013 Scientific Update Pooled efficacy data from two proof-of-concept trials in Atopic dermatitis presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD-2013) [123] Updated 05 Mar 2013
31 Dec 2012 Trial Update Regeneron & Sanofi complete a phase II trial in Atopic dermatitis (combination therapy) in Germany, Hungary & Poland (NCT01639040) Updated 14 Jun 2013
12 Nov 2012 Trial Update Regeneron & Sanofi complete enrolment in a phase II trial for Atopic dermatitis (combination therapy) in Germany, Hungary & Poland (NCT01639040) Updated 31 Dec 2012
01 Oct 2012 Trial Update Regeneron and Sanofi complete a phase II clinical trial for Asthma (combination therapy) in USA (NCT01312961) Updated 07 Dec 2012
01 Oct 2012 Trial Update Sanofi completes a phase I trial in healthy volunteers in Japan (NCT01537653) Updated 07 Dec 2012
01 Aug 2012 Trial Update Sanofi continues enrolment in a phase I trial in healthy Japanese subjects (NCT01537653) Updated 23 Aug 2012
31 Jul 2012 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Germany (SC, combination therapy) Updated 31 Dec 2012
31 Jul 2012 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Hungary (SC, combination therapy) Updated 31 Dec 2012
31 Jul 2012 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Poland (SC, combination therapy) Updated 31 Dec 2012
31 Jul 2012 Trial Update Regeneron & Sanofi complete a phase Ib trial in Atopic dermatitis in USA (NCT01259323) Updated 31 Dec 2012
16 Jul 2012 Trial Update Regeneron Pharmaceuticals and Sanofi complete a Phase-I trial in healthy volunteers in USA (NCT01537640) Updated 31 Jul 2012
29 May 2012 Trial Update Sanofi completes enrolment in its phase I trial for Asthma (in volunteers) in Japan (NCT01537653) Updated 21 Jun 2012
16 May 2012 Trial Update Sanofi & Regeneron complete enrolment in a phase I trial in Healthy volunteers in USA (NCT01537640) Updated 18 Jun 2012
31 Mar 2012 Trial Update Regeneron & Sanofi complete a phase I/II trial in Atopic dermatitis in Germany, Australia & New Zealand (NCT01385657) Updated 31 Dec 2012
12 Mar 2012 Trial Update Regeneron and Sanofi-Aventis complete a phase I trial in healthy volunteers in USA (NCT01484600) Updated 25 Mar 2012
01 Mar 2012 Phase Change - I Phase-I clinical trials in Asthma (in volunteers) in Japan (SC) Updated 13 Apr 2012
29 Feb 2012 Trial Update Sanofi and Regeneron Pharmaceuticals initiates enrolment in a phase I trial in Healthy volunteers in USA (NCT01537640) Updated 08 Mar 2012
28 Feb 2012 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Czech Republic (SC) Updated 14 Mar 2012
28 Feb 2012 Phase Change - II Phase-II clinical trials in Atopic dermatitis in France (SC) Updated 14 Mar 2012
28 Feb 2012 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Germany (SC) Updated 14 Mar 2012
28 Feb 2012 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Hungary (SC) Updated 14 Mar 2012
28 Feb 2012 Phase Change - II Phase-II clinical trials in Atopic dermatitis in Poland (SC) Updated 14 Mar 2012
31 Jul 2011 Phase Change - I/II Phase-I/II clinical trials in Atopic dermatitis in Australia (SC) Updated 08 Mar 2012
31 Jul 2011 Phase Change - I/II Phase-I/II clinical trials in Atopic dermatitis in Germany (SC) Updated 08 Mar 2012
31 Jul 2011 Phase Change - I/II Phase-I/II clinical trials in Atopic dermatitis in New Zealand (SC) Updated 08 Mar 2012
06 May 2011 Company Involvement sanofi-aventis is now called Sanofi Updated 07 Oct 2011
15 Mar 2011 Phase Change - II Phase-II clinical trials in Asthma in USA (SC, combination therapy) Updated 21 Mar 2011
15 Dec 2010 Phase Change - I Phase-I clinical trials in Atopic dermatitis in USA (SC) Updated 02 Mar 2011
28 Jul 2010 Trial Update Regeneron completes a phase I trial in healthy volunteers in USA Updated 30 Jul 2010
31 Oct 2009 Phase Change - I Phase-I clinical trials in Asthma in USA (Parenteral) Updated 07 Apr 2010
31 Oct 2009 Phase Change - I Phase-I clinical trials in Atopic dermatitis in USA (Parenteral) Updated 07 Apr 2010

References

  1. Regeneron Reports First Quarter 2023 Financial and Operating Results.

    Media Release

  2. Press Release: Strong execution in Q2 drives full-year 2022 guidance upgrade and delivers rich R&D news flow in Immunology and Rare Disease.

    Media Release

  3. Combined General Shareholder Meeting of May 6, 2011.

    Media Release

  4. Nestle Completes Acquisition of Aimmune Therapeutics.

    Media Release

  5. Sanofi and Regeneron to accelerate and expand investment for cemiplimab and dupilumab development programs.

    Media Release

  6. Sanofi-aventis and Regeneron Expand Strategic Antibody Collaboration.

    Media Release

  7. Sanofi-aventis initiates a major global collaboration with Regeneron to develop and commercialize fully-human therapeutic antibodies and plans to increase its stake in Regeneron to approximately 19 %.

    Media Release

  8. Dupixent(Rm) (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement.

    Media Release

  9. Sales growth accelerated - Full-year guidance raised.

    Media Release

  10. DUPIXENT(R) (dupilumab injection) now approved in Canada for children as young as six months old with severe atopic dermatitis.

    Media Release

  11. Press Release: Dupixent(Rm) (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis.

    Media Release

  12. Regeneron Reports First Quarter 2022 Financial and Operating Results.

    Media Release

  13. Dupixent(R) (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis.

    Media Release

  14. FDA Approves Dupixent(Rm) (dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis.

    Media Release

  15. FDA accepts Dupixent(R)(dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.

    Media Release

  16. DUPIXENT(Rm) (dupilumab injection) pre-filled pen now available in Canada, providing convenient self-administration option for people with type 2 inflammatory diseases.

    Media Release

  17. Quebec extends public reimbursement of DUPIXENT(Rm) (dupilumab injection) for the treatment of moderate-to-severe atopic dermatitis to include adolescents.

    Media Release

  18. Health Canada approves DUPIXENT(Rm) (dupilumab injection) as the first biologic for the treatment of moderate-to-severe atopic dermatitis in children aged 6 to 11 years.

    Media Release

  19. Press Release: Continued strong growth in Q3 with key regulatory milestones achieved.

    Media Release

  20. Dupixent(Rm) (dupilumab) approved in China for adults with moderate-to-severe atopic dermatitis.

    Media Release

  21. FDA Approves Dupixent(Rm) (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis.

    Media Release

  22. Sanofi delivers 2018 business EPS growth of 5.1% at CER.

    Media Release

  23. Sanofi: First-quarter 2018 Business EPS(1) up 1.4% at CER.

    Media Release

  24. Specialty Care growth, strong launch uptake of Beyfortus and ALTUVIIIO drive solid Q3 results.

    Media Release

  25. Regeneron Reports First Quarter 2017 Financial and Operating Results.

    Media Release

  26. Sanofi and Regeneron Announce FDA Approval of Dupixent(Rm) (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis.

    Media Release

  27. Regeneron and Sanofi Announce FDA Approval of DUPIXENT(Rm) (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis.

    Media Release

  28. Regeneron and Sanofi Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA.

    Media Release

  29. Regeneron Reports Second Quarter 2016 Financial and Operating Results.

    Media Release

  30. FDA approves Dupixent(R) (dupilumab) for moderate-to-severe atopic dermatitis in adolescents.

    Media Release

  31. FDA grants priority review for Dupixent(R) (dupilumab) as potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis.

    Media Release

  32. Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER.

    Media Release

  33. CHMP recommends approval of Dupixent(Rm) (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis.

    Media Release

  34. Sanofi delivers strong 2019 business EPS growth of 6.8% at CER.

    Media Release

  35. Dupixent(R) (dupilumab) Approved by European Commission for Adolescents with Moderate-to-Severe Atopic Dermatitis.

    Media Release

  36. Sanofi : CHMP recommends approval of Dupixent(R) (dupilumab) for moderate-to-severe atopic dermatitis in adolescents.

    Media Release

  37. Sanofi and Regeneron Announce Approval of Dupixent(R) (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis in the European Union.

    Media Release

  38. Regeneron and Sanofi Receive Positive CHMP Opinion for Dupixent(R) (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis.

    Media Release

  39. Sanofi and Regeneron Announce Marketing Authorization Application for Dupixent(Rm) (dupilumab) Accepted for Review by the EMA.

    Media Release

  40. Regeneron Reports Third Quarter 2018 Financial and Operating Results.

    Media Release

  41. First targeted treatment for adults with moderate-to-severe atopic dermatitis, Dupixent(TM), now available in Canada.

    Media Release

  42. Health Canada approves Dupixent(T) as the first biologic for the treatment of adolescents with moderate-to-severe atopic dermatitis 27 Sep 19.

    Media Release

  43. Health Canada approves Dupixent(T), the first targeted treatment for adults with moderate-to-severe atopic dermatitis.

    Media Release

  44. First targeted biologic for moderate-to-severe atopic dermatitis registered in Australia.

    Media Release

  45. REGENERON PHARMACEUTICALS - FORM 10K. Internet-Doc 2023;.

    Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/872589/000180422023000008/regn-20221231.htm

  46. Regeneron Reports First Quarter 2018 Financial and Operating Results.

    Media Release

  47. Regeneron Announces Approval of DUPIXENT(R) (dupilumab) in Japan for the Treatment of Atopic Dermatitis.

    Media Release

  48. Regeneron Reports Third Quarter 2023 Financial and Operating Results.

    Media Release

  49. Sanofi denounces CADTH negative recommendation that could limit treatment options for Canadians with atopic dermatitis.

    Media Release

  50. FDA accepts for priority review Dupixent(Rm) (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis.

    Media Release

  51. SANOFI RESPONDS TO DRAFT NICE GUIDANCE FOR ITS INNOVATIVE ATOPIC DERMATITIS DRUG DUPIXENT(Rm)##9660## (DUPILUMAB)1.

    Media Release

  52. UK Patients Granted Early Access to Sanofi's Innovative Dermatology Treatment Dupilumab by MHRA.

    Media Release

  53. Regeneron Reports Third Quarter 2016 Financial and Operating Results.

    Media Release

  54. Sanofi and Regeneron Announce that Dupilumab Has Received FDA Breakthrough Therapy Designation in Atopic Dermatitis.

    Media Release

  55. Compassionate Use of Dupilumab

    ctiprofile

  56. Busse W, Pavord I, Siddiqui S, Khan A, Praestgaard A, Nash S, et al. Dupilumab Improves CRSwNP/Asthma Outcomes In Patients With CRSwNP And Comorbid Asthma Irrespective Of Asthma Characteristics. ACAAI-2021 2021; abstr. P183.

    Available from: URL: https://epostersonline.com/acaai2021/poster/p183

  57. Gurnell M, Menzies-Gow A, Bachert C, Lugogo N, Cho S, Siddiqui S, et al. Dupilumab reduces asthma disease burden and recurrent SCS use in patients with CRSwNP and coexisting asthma. AAAAI-2022 2022; abstr. 377.

    Available from: URL: https://annualmeeting.aaaai.org/

  58. Cho S, Tan B, Cohen N, Tversky J, Toskala E, Nash S, et al. -- please add a title --. AAAAI-2022 2022; abstr. 431.

    Available from: URL: https://annualmeeting.aaaai.org/

  59. A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Dupilumab Compared to Placebo in Japanese Patients With Atopic Dermatitis Aged 6 Months to <18 Years Whose Disease is Not Adequately Controlled With Existing Therapies

    ctiprofile

  60. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis

    ctiprofile

  61. Press Release: Dupixent(R) (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis.

    Media Release

  62. Paller AS, Simpson EL, Siegfried EC, Cork MJ, Wollenberg A, Arkwright PD, et al. Dupilumab Treatment Improves Sleep Quality in Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis and Their Caregivers. AAD-2023 2023; abstr. 41817.

    Available from: URL: https://eposters.aad.org/abstracts/41817

  63. A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate-to-severe Atopic Dermatitis

    ctiprofile

  64. Beck L, Muraro A, Boguniewicz M, Chen Z, Levit N, Marco AR. Dupilumab Reduces Inflammatory Biomarkers in Patients Aged 6 Months to 18 Years With Moderate-to-Severe or Severe Atopic Dermatitis. AAAAI-2023 2023; abstr. 465.

    Available from: URL: https://annualmeeting.aaaai.org/

  65. Regeneron Reports Second Quarter 2019 Financial and Operating Results.

    Media Release

  66. A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of dupilumab administered concomitantly with topical corticosteroids in patients ≥6 years to <12 years of age, with severe atopic dermatitis

    ctiprofile

  67. Dupixent(Rm) (dupilumab) Showed Positive Topline Results in Phase 3 Trial of Children Aged 6 to 11 Years with Severe Atopic Dermatitis.

    Media Release

  68. Dupixent(Rm) (dupilumab) Phase 3 Data at Revolutionizing Atopic Dermatitis Conference Show Significant Improvement in Severe Atopic Dermatitis for Children Aged 6 to 11 Years.

    Media Release

  69. Beck L, Wollenberg A, Paller A, Siegfried E, Chen Z, Abramova A, et al. Dupilumab Improves Signs And Symptoms Of Severe Atopic Dermatitis In Children Aged 611 Years With And Without Comorbid Allergic Rhinitis. AAAAI-2021 2021; abstr. 461.

    Available from: URL: https://annualmeeting.aaaai.org/

  70. Boguniewicz M, Sher L, Paller A, Siegfried E, Chen Z, Prescilla R, et al. Dupilumab Improves Signs And Symptoms Of Severe Atopic Dermatitis In Children Aged 6 11 Years With And Without Comorbid Asthma. AAAAI-2021 2021; abstr. 099.

    Available from: URL: https://annualmeeting.aaaai.org/

  71. Positive Phase 3 Dupixent(Rm) (dupilumab) data in children 6 months to 5 years with moderate-to-severe atopic dermatitis featured in RAD 2021 late-breaking session.

    Media Release

  72. A phase 3 study investigating the efficacy, safety, and tolerability of Dupilumab administered to adult patients with severe atopic dermatitis who are not adequately controlled with or are intolerant to oral cyclosporine A, or when this treatment is not medically advisable

    ctiprofile

  73. Sanofi and Regeneron Announce Positive Study Results for Dupixent(R) (dupilumab) in Patients With Moderate-to-Severe Atopic Dermatitis.

    Media Release

  74. Regeneron and Sanofi Announce Positive Study Results for DUPIXENT(R) (dupilumab) in Patients With Moderate-to-Severe Atopic Dermatitis.

    Media Release

  75. Paller A, Siegfried E, Sidbury R, Lockshin B, Cork M, Pinter A, et al. Treatment-Emergent Adverse Events in Patients Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis Treated With Dupilumab in an Open-Label Extension Clinical Trial. AAD-2023 2023; abstr. 42924.

    Available from: URL: https://eposters.aad.org/abstracts/42924

  76. Siegfried E, Cork MJ, Lockshin B, Boguniewicz M, Uppal S, Vass M, et al. Long Term Hematologic Laboratory Safety of Dupilumab in Patients Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis. AAD-2023 2023; abstr. 42008.

    Available from: URL: https://eposters.aad.org/abstracts/42008

  77. A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE EFFICACY AND SAFETY OF MULTIPLE DUPILUMAB DOSE REGIMENS ADMINISTERED AS MONOTHERAPY FOR MAINTAINING TREATMENT RESPONSE IN PATIENTS WITH ATOPIC DERMATITIS

    ctiprofile

  78. Simpson E, Lacour J-P, Beck L, Zhang H, Aamodt K, ROSSI AB. Patient Perception Of Treatment With Long-Term Dupilumab Monotherapy In Adults With Moderate-To-Severe Atopic Dermatitis. ACAAI-2021 2021; abstr. P196.

    Available from: URL: https://epostersonline.com/acaai2021/poster/p196

  79. Regeneron and Sanofi Announce Positive Dupixent(R) (dupilumab) Phase 3 Atopic Dermatitis Data Published in the New England Journal of Medicine.

    Media Release

  80. A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  81. Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent(R) (dupilumab) in Moderate-to-Severe Atopic Dermatitis.

    Media Release

  82. Regeneron and Sanofi Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of DUPIXENT(R) (dupilumab) in Moderate-to-Severe Atopic Dermatitis.

    Media Release

  83. Regeneron and Sanofi Announce that Dupilumab Used with Topical Corticosteroids (TCS) was Superior to Treatment with TCS Alone in Long-term Phase 3 Trial in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients.

    Media Release

  84. Regeneron and Sanofi Announce Start of Phase 3 Study of Dupilumab in Patients with Atopic Dermatitis.

    Media Release

  85. Sanofi and Regeneron Announce Start of Phase 3 Study of Dupilumab in Patients with Atopic Dermatitis.

    Media Release

  86. A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

    ctiprofile

  87. Kim B, Beck L, Simpson E, Eichen?eld L, Silverberg J, Eyerich K, et al. DupilumabReduction of IgELevels and Probability of AtopicDermatitisFlares- Analysis of A Randomized Placebo-Controlled 52-Week Study. AAAAI-2024 2024; abstr. 044.

    Available from: URL: https://annualmeeting.aaaai.org/

  88. AN OPEN-LABEL STUDY OF DUPILUMAB IN PATIENTS WITH ATOPIC DERMATITIS WHO PARTICIPATED IN PREVIOUS DUPILUMAB CLINICAL TRIALS

    ctiprofile

  89. Deleuran M, Thaci D, Beck LA, Forman S, Soong W, Hussain I, et al. Long-Term Safety and Efficacy of Open-Label Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis. AAAAI-2017 2017; abstr. L21.

    Available from: URL: http://www.sciencedirect.com/science/article/pii/S0091674916324332

  90. Wollenberg A, Beck L, Deleuran MS, Blauvelt A, Thyssen J, de Bruin-Weller M, et al. Safety of Long-Term Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis up to 172 Weeks: Results from an Open-Label Extension (OLE) Trial. AAAAI-2022 2022; abstr. 030.

    Available from: URL: https://annualmeeting.aaaai.org/

  91. Blauvelt A, Eichenfield L, Sierka D, Chen Z, Khokhar F, Marco AR, et al. Long-Term Safety in Adults With Moderate-to-Severe Atopic Dermatitis Treated With Dupilumab up to 4 years. ACAAI-2022 2022; abstr. P016.

    Available from: URL: https://epostersonline.com/acaai2022/poster/p016

  92. Beck L, Deleuran M, Gonzalez T, Xiao J, Avetisova E, Dubost-Brama A, et al. Efficacy of Dupilumab in a 5-Year Open-Label Extension Study of Adults With Moderate-to-Severe Atopic Dermatitis. ACAAI-2023 2023; abstr. P283.

    Available from: URL: https://epostersonline.com//acaai2023/poster/p283

  93. Beck L, Bissonnette R, Deleuran M, Nakahara T, Galus R, Xiao J, et al. Long-Term Efficacy Of Dupilumab In Adults With Moderate-to-Severe Atopic Dermatitis: ResultsFrom A 5-Year Open-Label Extension Trial. AAAAI-2024 2024; abstr. 015.

    Available from: URL: https://annualmeeting.aaaai.org/

  94. A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  95. Sanofi Delivers Robust Q1 2017 Financial Results.

    Media Release

  96. A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

    ctiprofile

  97. Paller A, Blauvelt A, Pariser D, Soong W, Hong HC-h, Zhang Q, et al. Dupilumab for Adolescents With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 3, Randomized, Double-Blinded Trial. AAD-2019 2019; abstr. 10051.

    Available from: URL: https://www.aad.org/eposters/view/Abstract.aspx?id=10051

  98. Positive Phase 3 Results Presented for Dupixent(R) (dupilumab) Show Significant Improvement on Multiple Measures of Disease Severity in Adolescents with Moderate-to-Severe Atopic Dermatitis.

    Media Release

  99. Sanofi: Positive Phase 3 results presented for Dupixent(R) (dupilumab).

    Media Release

  100. Sanofi: Dupixent(Rm) (dupilumab) showed positive Phase 3 results in adolescents with inadequately controlled moderate-to-severe atopic dermatitis.

    Media Release

  101. Regeneron Reports Fourth Quarter and Full Year 2016 Financial and Operating Results.

    Media Release

  102. Simpson E, Cork M, Arkwright P, Deleuran M, Chen Z, Marco AR, et al. Dupilumab Decreases Total and Allergen-Specific IgE in Adolescents With Moderate-to-Severe Atopic Dermatitis (AD). ACAAI-2021 2021; abstr. P193.

    Available from: URL: https://epostersonline.com/acaai2021/poster/p193

  103. Regeneron Reports Fourth Quarter and Full Year 2017 Financial and Operating Results.

    Media Release

  104. A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  105. Dupixent(Rm) (dupilumab) pivotal trial meets all primary and secondary endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months.

    Media Release

  106. Positive Dupixent(Rm) (dupilumab) Phase 3 Data in Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis Published in The Lancet.

    Media Release

  107. Boguniewicz M, Sher L, Paller A, Chen Z, Shah P, Rodriguez-Marco A. Dupilumab Efficacy in Children With Atopic Dermatitis Aged 6 Months to 5 Years With and Without Atopic Comorbidities. AAAAI-2023 2023; abstr. 453.

    Available from: URL: https://annualmeeting.aaaai.org/

  108. Dupixent(Rm) (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis.

    Media Release

  109. Boguniewicz M, Sher L, Paller A, Chen Z, Shah P, Marco AR. Efficacy and Safety of Dupilumab in Preschool Children With Atopic Dermatitis and Type 2 Comorbidities. ACAAI-2023 2023; abstr. P112.

    Available from: URL: https://epostersonline.com//acaai2023/poster/p112

  110. A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  111. Regeneron Reports Third Quarter 2015 Financial and Operating Results.

    Media Release

  112. A Phase 2A Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years With Atopic Dermatitis

    ctiprofile

  113. A Randomized, Double-Blind, Placebo-Controlled, Study Investigating Vaccine Responses in Adults With Moderate to Severe Atopic Dermatitis Treated With Dupilumab

    ctiprofile

  114. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy, Safety, Serum Concentration and Biomarker Profile of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  115. Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis.

    Media Release

  116. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of Dupilumab (REGN668) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  117. A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  118. A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study of the Efficacy, Safety, Tolerability, and Pharmacodynamics of Subcutaneously-Administered REGN668 in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  119. A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Atopic Dermatitis

    ctiprofile

  120. An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis

    ctiprofile

  121. An Open-Label, Drug-Drug Interaction Study to Examine the Effects of Dupilumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Patients With Moderate to Severe Atopic Dermatitis

    ctiprofile

  122. Regeneron Reports First Quarter 2013 Financial and Operating Results.

    Media Release

  123. Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis.

    Media Release

  124. A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Extrinsic Atopic Dermatitis

    ctiprofile

  125. FDA expands approval of Dupixent(Rm) (dupilumab) to include children aged 6 to 11 years with moderate-to-severe asthma.

    Media Release

  126. FDA accepts Dupixent(Rm) (dupilumab) for review in children with moderate-to-severe asthma.

    Media Release

  127. NICE Recommends Dupixent(Rm) (dupilumab) for the Treatment of Severe Asthma[1].

    Media Release

  128. Press Release: Dupixent(Rm) (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation.

    Media Release

  129. CHMP recommends approval of Dupixent(Rm) (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation.

    Media Release

  130. Regeneron Reports First Quarter 2021 Financial and Operating Results.

    Media Release

  131. Dupixent(Rm) (dupilumab) Approved for Severe Asthma by European Commission.

    Media Release

  132. Sanofi: CHMP recommends approval of Dupixent(R)(dupilumab) for asthma indication.

    Media Release

  133. New add-on treatment for patients with severe asthma.

    Media Release

  134. EMA to Review DUPIXENT(R) (dupilumab) as Potential Treatment for Inadequately Controlled Moderate-to-Severe Asthma.

    Media Release

  135. Dupixent(R)(dupilumab injection) now approved in Canada for the treatment of severe asthma in children aged six to 11 years with type 2 inflammation.

    Media Release

  136. DUPIXENT(Rm) (dupilumab injection) now approved by Health Canada for patients with severe asthma Francais.

    Media Release

  137. Dupixent Japan approval for Asthma. Internet-Doc 2019;.

    Available from: URL: http://www.pmda.go.jp/PmdaSearch/iyakuDetail/780069_4490405G1024_1_04#WARNINGS

  138. Sanofi: FDA approves asthma indication for Dupixent(R) (dupilumab).

    Media Release

  139. FDA to Review DUPIXENT(R) (dupilumab) as Potential Treatment for Moderate-to-Severe Asthma.

    Media Release

  140. Sanofi: First-quarter 2018 Business EPS up 1.4% at CER.

    Media Release

  141. A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze

    ctiprofile

  142. A Two-arm, Placebo-controlled Randomized Clinical Trial to Evaluate the Effect of Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma With a "T2 Immune Signature"

    ctiprofile

  143. A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

    ctiprofile

  144. Zhang Q, Nanshan Z, Dhooria S, Fu X, Lin J, Li W, et al. Efficacy and Safety of Dupilumab in Patients With Persistent Asthma From the Asia-Pacific Region: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study. ATS-2023 2023; abstr. P621.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/12528

  145. Zhang Q, Nanshan Z, Dhooria S, Fu X, Lin J, Li W, et al. Dupilumab in Asia-Pacific patients with persistent asthma. ERS-2023 2023; abstr. 5286.

    Available from: URL: https://live.ersnet.org/ers/ers2023/en-GB/presentation/554757

  146. One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

    ctiprofile

  147. Press Release: Late-breaking Dupixent(Rm) (dupilumab) data at ERS 2022 show consistent efficacy and safety profile for up to two years in children aged 6 to 11 years with moderate-to-severe asthma.

    Media Release

  148. Late-Breaking Dupixent(R) (dupilumab) Data at ERS 2022 Show Consistent Efficacy and Safety Profile for Up to Two Years in Children Aged 6 to 11 Years with Moderate-to-severe Asthma.

    Media Release

  149. Bacharier L, Maspero J, Katelaris C, Fiocchi A, Gagnon R, De Mir-Messa I, et al. Long-Term Safety And Efficacy Of Dupilumab In Children With Asthma: LIBERTY ASTHMA EXCURSION. ACAAI-2022 2022; abstr. P105.

    Available from: URL: https://epostersonline.com/acaai2022/poster/p105

  150. Bacharier L, Maspero J, Katelaris C, Fiocchi A, Gagnon R, de Mir I, et al. Long-Term Dupilumab Treatment Effect On Safety And Clinical Efficacy In Children With Type 2 Asthma: LIBERTY ASTHMA EXCURSION. AAAAI-2023 2023; abstr. 047.

    Available from: URL: https://annualmeeting.aaaai.org/

  151. Bacharier LB, Maspero JF, Katelaris CH, Fiocchi AG, Gagnon R, de Mir I, et al. Dupilumab Improved Long-term Lung Function in Children Aged 6 to 11 Years With Moderate-to-Severe Asthma: Liberty Asthma Excursion. ATS-2023 2023; abstr. 206.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/10880

  152. Bacharier L, Guilbert T, Custovic A, Altincatal A, Ledanois O, Gall R, et al. Long-term dupilumab effect on lung function in paediatric patients with uncontrolled asthma. ERS-2023 2023; abstr. 2091.

    Available from: URL: https://live.ersnet.org/ers/ers2023/en-GB/presentation/554488

  153. New England Journal of Medicine publishes positive Phase 3 Dupixent(Rm) (dupilumab) results in children with moderate-to-severe asthma.

    Media Release

  154. Pivotal data at ATS 2021 show Dupixent(Rm) (dupilumab) significantly reduced asthma attacks and improved lung function in children.

    Media Release

  155. Bacharier LB, Maspero JF, Katelaris CH, Fiocchi AG, Gagnon R, de Mir I, et al. Dupilumab Efficacy and Safety in Children with Uncontrolled, Moderate-to-Severe Asthma: The Phase 3 VOYAGE Study. ATS-2021 2021; abstr. A1204.

    Available from: URL: https://conference.thoracic.org/program/abstract-search.php?sid=P5839

  156. Dupixent(Rm) (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in childrens lung function in a randomized Phase 3 trial.

    Media Release

  157. A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma

    ctiprofile

  158. Bacharier L, Maspero J, Katelaris C, Fiocchi A, Liu D, Lederer D, et al. Dupilumab Reduces Biomarkers of Type 2 Inflammation in Children With Uncontrolled, Moderate-to-Severe Asthma. ACAAI-2021 2021; abstr. P068.

    Available from: URL: https://epostersonline.com/acaai2021/poster/p068

  159. Fiocchi A, Phipatanakul W, Durrani SR, Cole J, Mao X, Msihid J, et al. Dupilumab improves asthma control and quality of life in children with uncontrolled persistent asthma. ERS-2021 2021; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/58/suppl_65/PA3920

  160. Papadopoulos N, Szefler SJ, Bacharier LB, Maspero JF, Domingo C, Daizadeh N, et al. Dupilumab efficacy in children with uncontrolled, moderate-to-severe asthma with and without an allergic phenotype. ERS-2021 2021; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/58/suppl_65/OA2568

  161. Bacharier L, Jackson D, Pavord I, Maspero J, Mao X, Liu D, et al. Efficacy of Dupilumab in Quadrants of Elevated-vs Low-Type 2 Biomarkers in Children With Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA VOYAGE. AAAAI-2022 2022; abstr. 050.

    Available from: URL: https://annualmeeting.aaaai.org/

  162. Guilbert TW, Bacharier LB, Deschildre A, Phipatanakul W, Altincatal A, Mannent L, et al. Dupilumab Impact on Lung Function in Children with Uncontrolled, Moderate-To-Severe Asthma and Elevated Type 2 Biomarkers. ATS-2022 2022; abstr. N/A.

    Available from: URL: https://link.adisinsight.com/m8P2D

  163. Guilbert TW, Deschildre A, Jackson DJ, Begin P, Zeiger RS, Szefler SJ, et al. Efficacy of Dupilumab in Pediatric Patients with Uncontrolled, Moderate-to-Severe Asthma With and Without Ongoing Atopic Comorbid Disease: LIBERTY ASTHMA VOYAGE. ATS-2022 2022; abstr. N/A.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10476/presentation/8278

  164. Maspero JF, Antila MA, Jain N, Deschildre A, Bacharier LB, Altincatal A, et al. Dupilumab efficacy in children with uncontrolled type 2 asthma with baseline high/medium ICS dose. ERS-2022 2022; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/60/suppl_66/2655

  165. Bacharier L, Jackson DJ, Pavord I, Maspero J, Fiocchi A, Mao X, et al. Continuous associations of type 2 biomarkers and efficacy of dupilumab in children with uncontrolled, moderate-to-severe asthma. ERS-2022 2022; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/60/suppl_66/2893

  166. Jackson D, Hamelmann E, Roberts G, Bacharier L, Altincatal A, Gall R-b, et al. Dupilumab Reduces Exacerbations And Improves Lung Function In Children (6-11 Years) With Moderate-To-Severe Asthma And High Eosinophils. AAAAI-2023 2023; abstr. 600.

    Available from: URL: https://annualmeeting.aaaai.org/

  167. Guilbert TW, Deschildre A, Murphy KR, Hamelmann E, Ross KR, Gupta A, et al. Dupilumab Improves Lung Function in Children With Moderate-to-Severe Type 2 Asthma at Week 12. ATS-2023 2023; abstr. 209.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/10889

  168. Corren J, Castro M, Maspero JF, Humbert M, Halpin DMG, Altincatal A, et al. Dupilumab improved lung function and reduces exacerbations in patients with 1, 2, or 3 prior exacerbations: TRAVERSE. ERS-2022 2022; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/60/suppl_66/2364

  169. Pavord ID, Wechsler ME, Busse W, Ribas CD, Xia C, Gall R, et al. Efficacy of Dupilumab in Patients With and Without a Minimally Important Reduction in Fractional Exhaled Nitric Oxide After 2 Weeks of Treatment. ATS-2023 2023; abstr. P598.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/10596

  170. Wechsler M, Pavord I, Papi A, Chapman K, Mao X, Ortiz B, et al. Long-Term Efficacy of Dupilumab in Quadrants of Elevated-vs Low-Type 2 Biomarker Patients With Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA TRAVERSE. AAAAI-2022 2022; abstr. 571.

    Available from: URL: https://annualmeeting.aaaai.org/

  171. A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

    ctiprofile

  172. Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

    ctiprofile

  173. Sanofi, Regeneron: Dupilumab Hits Main Objectives in Late-Stage Asthma Trial.

    Media Release

  174. New England Journal of Medicine publishes two positive Phase 3 trials showing Dupixent(R) (dupilumab) improved moderate-to-severe asthma.

    Media Release

  175. Bousquet J, Maspero JF, Chipps BE, Corren J, FitzGerald JM, Chen Z, et al. Dupilumab Consistently Improves Rhinoconjunctivitis-Specific Health-Related Quality of Life in Patients With Uncontrolled, Moderate-to-Severe Asthma and Comorbid Allergic Rhinitis: Results from the Phase 3 LIBERTY ASTHMA QUEST Study. AAAAI-2019 2019; abstr. 304.

    Available from: URL: http://link.adisinsight.com/p9KEj

  176. Rabe K, FitzGerald JM, Castro M, Pavord I, Maspero J, Busse W, et al. Dupilumab Efficacy in GINA-Defined Difficult- to-Treat Type 2 Asthma Patients in the LIBERTY ASTHMA QUEST Study. AAAAI-2021 2021; abstr. 183.

    Available from: URL: https://annualmeeting.aaaai.org/

  177. Hanania N, Maspero J, Panettieri RA, Castro M, Daizadeh N, Djandji M, et al. Effect of dupilumab on severe exacerbations in asthma patients with and without lung function improvements. ERS-2020 2020; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/56/suppl_64/2268

  178. Korn S, Busse WW, Echave-Sustaeta JM, Dixon AE, Mucsi J, Rice MS, et al. Dupilimab Efficacy in Patients with Uncontrolled, Moderate-to-Severe Asthma by Body Mass Index. ERS-2019 2019; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/54/suppl_63/PA2753

  179. Papi A, Pavord ID, Fitzgerald JM, Corren J, Bardin P, Park HS, et al. Dupilumab Efficacy in Asthma Patients With FEV1 60-80% Predicted on Medium-Dose ICS: liberty asthma quest Study. ERS-2019 2019; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/54/suppl_63/PA538

  180. Carr W, Jackson DJ, Corren J, Bergmann K-C, Rice MS, Deniz Y, et al. Dupilumab Efficacy in Patients With Uncontrolled, Moderate-to-Severe Asthma by Immunoglobin E Levels at Baseline. ERS-2019 2019; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/54/suppl_63/PA536

  181. Castro M, Corren J, Casale TB, Quirce S, Rice MS, Deniz Y, et al. Dupilumab Effect on Lung Function in Patients With Uncontrolled, Moderate-to-Severe Asthma With an Allergic Phenotype. ERS-2019 2019; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/54/suppl_63/PA540

  182. Castro M, Rabe KF, Kraft M, Corren J, Pavord ID, Katelaris C, et al. Dupilumab Improved Lung Function in Patients with Uncontrolled, Moderate-to-Severe Asthma. ATS-2019 2019; abstr. A7086/508.

    Available from: URL: http://link.adisinsight.com/g9S3C

  183. Bourdin A, Virchow JC, Papi A, Lugogo NL, Halpin D, Daizadeh N, et al. Dupilumab Efficacy In Patients With Type 2 Asthma With/Without Allergic Phenotype Receiving High-Dose Inhaled Corticosteroids. ACAAI-2021 2021; abstr. P066.

    Available from: URL: https://epostersonline.com/acaai2021/poster/p066

  184. Pavord ID, Deniz Y, Casale T, Corren J, Fitzgerald M, Daizadeh N, et al. Relation between reduction in fractional exhaled nitric oxide and efficacy in asthma patients treated with dupilumab. ERS-2022 2022; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/60/suppl_66/2256

  185. Pavord ID, Brusselle G, Jackson DJ, Brightling CE, Papi A, Maspero JF, et al. FeNO as a Potential Prognostic and Predictive Marker of Lung Function Decline in Patients with Uncontrolled, Moderate-to-Severe Asthma: LIBERTY ASTHMA QUEST. ATS-2022 2022; abstr. N/A.

    Available from: URL: https://link.adisinsight.com/w6PMr

  186. Sher L, Wechsler M, Rabe KF, Maspero JF, Daizadeh N, Mao X, et al. Assessment of Long-Term Maintenance of OCS Reduction and Efficacy in the Dupilumab LIBERTY ASTHMA TRAVERSE Extension Study. ATS-2021 2021; abstr. A1441.

    Available from: URL: https://conference.thoracic.org/program/abstract-search.php?sid=P8544

  187. Wechsler M, Ford LB, Maspero JF, Pavord ID, Langton D, Domingo C, et al. Dupilumab Shows Sustained Efficacy and Improvements in Asthma Control and Health-Related Quality of Life in Patients with Moderate-to-Severe Asthma: LIBERTY ASTHMA TRAVERSE. ATS-2021 2021; abstr. A1452.

    Available from: URL: https://conference.thoracic.org/program/abstract-search.php?sid=P8556

  188. Sher L, Corren J, Pavord I, Daiza-deh N, Ortiz B, Djandji M, et al. Long-Term Efficacy of Dupilumab in Patients With Asthma With an Allergic Phenotype Rolled Over From LIBERTY ASTHMA QUEST: LIBERTY ASTHMA TRAVERSE Study. AAAAI-2021 2021; abstr. 184.

    Available from: URL: https://annualmeeting.aaaai.org/

  189. Dupixent(Rm) (dupilumab) long-term data show sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma.

    Media Release

  190. Wechsler M, Pavord ID, Papi A, Chapman KR, Mao X, Ortiz B, et al. Long-Term Dupilumab Treatment in Moderate-to-Severe Asthma with Type 2 Inflammation: Open Label LIBERTY ASTHMA TRAVERSE Study. ATS-2021 2021; abstr. A1201.

    Available from: URL: https://conference.thoracic.org/program/abstract-search.php?sid=P5845

  191. Sher L, Wechsler ME, Rabe KF, Maspero JF, Daizadeh N, Mao X, et al. Dupilumab sustains long-term OCS reduction in OCS-dependent asthma patients. ERS-2021 2021; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/58/suppl_65/PA2519

  192. Gurnell M, Ribas CD, Rabe KF, Menzies-Gow A, Price D, Brusselle G, et al. Persistent Reductions in OCS Use in Patients with Severe, OCS-Dependent Asthma Treated with Dupilumab: LIBERTY ASTHMA TRAVERSE Study. ATS-2022 2022; abstr. N/A.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10476/presentation/8281

  193. Papi A, Castro M, Busse WW, Langton D, Korn S, Xia C, et al. Dupilumab improves exacerbations and lung function irrespective of prior asthma exacerbations: TRAVERSE. ERS-2022 2022; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/60/suppl_66/2354

  194. Sher L, Corren J, Pavord I, Pandit-Abid N, Radwan A, Jacob-Nara J, et al. Long-Term Dupilumab Reduces Exacerbations And Improves Lung Function In Type 2 Patients With/Without Allergic. ACAAI-2022 2022; abstr. P106.

    Available from: URL: https://epostersonline.com/acaai2022/poster/p106

  195. Papi A, Castro M, Busse W, Korn S, Xia C, Soler X, et al. Dupilumab Reduces Exacerbations And Improves Lung Function Regardless Of Prior Asthma Exacerbation Status: LIBERTY ASTHMA TRAVERSE Open-Label Extension Study. AAAAI-2023 2023; abstr. 597.

    Available from: URL: https://annualmeeting.aaaai.org/

  196. Maspero JF, Corren J, Katelaris C, Castro M, Humbert MJ, Halpin DM, et al. -- please add a title --. ATS-2023 2023; abstr. P596.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/10871

  197. Maspero JF, Peters A, Chapman KR, Domingo C, Stewart J, Hardin M, et al. Long-term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: The Liberty Asthma Traverse Continuation Study. ATS-2023 2023; abstr. P595.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/10587

  198. Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial

    ctiprofile

  199. A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of dupilumab in adolescents and adults with moderate to severe uncontrolled asthma

    ctiprofile

  200. Sanofi : Dupilumab Significantly Reduced Steroid Use, Asthma Attacks, and Improved Lung Function in a Phase 3 Study of People with Severe Steroid-Dependent Asthma.

    Media Release

  201. Dupilumab Significantly Reduced Steroid Use, Asthma Attacks, and Improved Lung Function in Phase 3 Study of People with Severe Steroid-Dependent Asthma.

    Media Release

  202. A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma

    ctiprofile

  203. Rabe KF, Nair PK, Brusselle GG, Maspero JF, Castro M, Zhu H, et al. Dupilumab in Patients with Corticosteroid-Dependent Severe Asthma: Efficacy and Safety Results from the Randomized, Double-Blind, Placebo-Controlled Phase 3 LIBERTY ASTHMA VENTURE Study. ATS-2018 2018; abstr. A7712.

    Available from: URL: http://link.adisinsight.com/Fp6m8

  204. Ford LB, Rabe KF, Wolfe RN, Quirce S, Rice MS, Rowe P, et al. Dupilumab Improved Asthma Control and Health-Related Quality of Life in Patients with Oral-Corticosteroid-Dependent Severe Asthma in the Phase 3 LIBERTY ASTHMA VENTURE Study. ATS-2019 2019; abstr. A2666/501.

    Available from: URL: http://link.adisinsight.com/f7JPc

  205. Sher L, Rabe KF, Wolfe RN, Quirce S, Rice MS, Rowe P, et al. Dupilumab Improved Morning and Evening Daily Asthma Symptoms in Patients with Oral-Corticosteroid-Dependent Severe Asthma in the Phase 3 LIBERTY ASTHMA VENTURE Study. ATS-2019 2019; abstr. A2669/504.

    Available from: URL: http://link.adisinsight.com/En4i2

  206. Maspero JF, Halpin DMG, Jackson D, Hanania NA, Castro M, Domingo C, et al. Effect of dupilumab on oral corticosteroid use in severe asthma patients with improving lung function. ERS-2020 2020; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/56/suppl_64/5282

  207. Brusselle G, Papi A, Chipps BE, Msihid J, Jacob-Nara JA, Deniz Y, et al. Efficacy of dupilumab in patients with oral corticosteroid (OCS)-dependent, severe asthma with and without an allergic phenotype: phase 3 LIBERTY ASTHMA VENTURE. ERS-2021 2021; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/58/suppl_65/PA2521

  208. Domingo C, Hanania N, Canonica G, Halpin D, Lugogo N, Rhee CK, et al. Association Between Baseline Characteristics and Oral Corticosteroid Reduction in Patients With Oral Corticosteroid-Dependent Severe Asthma. ACAAI-2023 2023; abstr. P139.

    Available from: URL: https://epostersonline.com

  209. Domingo C, Hanania N, Canonica G, Hal-pin D, Lugogo N, Rhee CK, et al. Association Of Baseline Lung Function And Likelihood Of Oral Corticosteroid Reduction In Patients With OCS-Dependent Severe Asthma. AAAAI-2024 2024; abstr. 308.

    Available from: URL: https://annualmeeting.aaaai.org/

  210. Regeneron and Sanofi Announce Positive Topline Phase 2 Results for IL-33 Antibody in Asthma.

    Media Release

  211. A Randomized, Double-blind, Placebo-controlled, Parallel-group, 12-week Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety, and Tolerability of SAR440340 and the Coadministration of SAR440340 and Dupilumab in Patients With Moderate-to-Severe Asthma Who Are Not Well Controlled on Inhaled Corticosteroid (ICS) Plus Long-acting β2 Adrenergic Agonist (LABA) Therapy

    ctiprofile

  212. Regeneron Reports Second Quarter 2014 Financial and Operating Results.

    Media Release

  213. Sanofi Provides an Update on its Research & Development Pipeline.

    Media Release

  214. A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

    ctiprofile

  215. Regeneron and Sanofi Announce Positive Pivotal Phase 2b Dupilumab Data in Asthma Presented at the American Thoracic Society 2015 International Conference.

    Media Release

  216. Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Asthma.

    Media Release

  217. Sanofi and Regeneron Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Asthma.

    Media Release

  218. An Exploratory, Randomized, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma

    ctiprofile

  219. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Allergic Bronchopulmonary Aspergillosis

    ctiprofile

  220. Press Release: Dupixent(Rm) sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation.

    Media Release

  221. Regeneron Reports Fourth Quarter and Full Year 2023 Financial and Operating Results.

    Media Release

  222. Press Release: Sanofi Delivers Solid Sales and Business EPS Growth at CER Amidst Successful Product Launches and Advancements in Immunology Pipeline.

    Media Release

  223. Regeneron Reports Second Quarter 2023 Financial and Operating Results.

    Media Release

  224. Dupixent(R) (dupilumab) Significantly Reduced COPD Exacerbations in Second Positive Phase 3 Trial, Accelerating FDA Submission and Confirming Potential to Become First Approved Biologic for This Serious Disease.

    Media Release

  225. A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation

    ctiprofile

  226. A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation

    ctiprofile

  227. Regeneron Collaborations on Dupixent(Rm) (dupilumab) Highlighted During Sanofi R&D Investor Event.

    Media Release

  228. Dupixent(Rm) (dupilumab) Late-breaking Phase 3 COPD Results Presented at ATS and Simultaneously Published in the New England Journal of Medicine.

    Media Release

  229. Dupixent(R) (dupilumab) Demonstrates Potential to Become First Biologic to Treat COPD by Showing Significant Reduction in Exacerbations in Pivotal Trial.

    Media Release

  230. Bhatt SP, Rabe KF, Hanania N, Vogelmeier C, Cole J, Bafadhel M, et al. A6817. Dupilumab Efficacy and Safety in Chronic Obstructive Pulmonary Disease with Type 2 Inflammation. ATS-2023 2023; abstr. N/A.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/13153

  231. Press Release: Japan first in the world to approve Dupixent(Rm) for chronic spontaneous urticaria (CSU).

    Media Release

  232. Japan First in the World to Approve Dupixent(Rm) (dupilumab) for Chronic Spontaneous Urticaria (CSU).

    Media Release

  233. Strong Q1 growth driven by Specialty Care, Vaccines and CHC.

    Media Release

  234. Regeneron and Sanofi Provide Update on Dupixent(R) (dupilumab) sBLA for Chronic Spontaneous Urticaria.

    Media Release

  235. Dupixent(Rm) (dupilumab) Application for Treatment of Chronic Spontaneous Urticaria (CSU) in Adults and Adolescents Aged 12 Years and Older Accepted for FDA Review.

    Media Release

  236. A Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)

    ctiprofile

  237. Update on ongoing Dupixent(Rm) (dupilumab) chronic spontaneous urticaria Phase 3 program.

    Media Release

  238. Regeneron Reports Third Quarter 2021 Financial and Operating Results.

    Media Release

  239. Dupixent(R)(dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients.

    Media Release

  240. Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab

    ctiprofile

  241. Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent(Rm) (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria.

    Media Release

  242. Maurer M, Casale T, Saini S, Ben-Shoshan M, Amin N, Radin A, et al. Dupilumab Significantly Reduces Itch and Hives in Patients With Chronic Spontaneous Urticaria: Results From a Phase 3 Trial (LIBERTY-CSU CUPID Study A). AAAAI-2022 2022; abstr. L01.

    Available from: URL: https://annualmeeting.aaaai.org/

  243. Maurer M, Casale T, Saini SR, Ben-Shoshan M, Radin A, Akinlade B, et al. Dupilumab Improves Urticaria Activity And Quality Of Life In Patients With Chronic Spontaneous Urticaria (CSU). AAAAI-2023 2023; abstr. 308.

    Available from: URL: https://annualmeeting.aaaai.org/

  244. Maurer M, Gimenez-Arnau A, Kaplan A, Saini S, Ensina LF, Hide M, et al. Dupilumab Reduces Disease Activity in Patients with Chronic Spontaneous Urticaria: LIBERTY-CSU CUPID Study A. AAAAI-2024 2024; abstr. 029.

    Available from: URL: https://annualmeeting.aaaai.org/

  245. A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of Dupilumab in Patients With Chronic Inducible Cold Urticaria Who Remain Symptomatic Despite the Use of H1-antihistamine Treatment

    ctiprofile

  246. Sanofi Q3 2020 business EPS(1) growth of 8.8% at CER.

    Media Release

  247. A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Phase 2, 16-week Treatment Study With a 16 Week Follow-up Period to Assess the Efficacy and Safety of Dupilumab (Anti-IL4Ra) in Adult Patients With Chronic Spontaneous Urticaria Despite H1-antihistamine Treatment

    ctiprofile

  248. Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy.

    ctiprofile

  249. Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma in the New England Journal of Medicine.

    Media Release

  250. Wenzel SE, Pirozzi G, Wang L, Kirkesseli S, Rocklin R, Radin A, et al. Efficacy And Safety Of SAR231893/REGN668 In Patients With Moderate-To-Severe, Persistent Asthma And Elevated Eosinophil Levels. 109th-ATS-2013 2013; abstr. N/A.

    Available from: URL: https://cms.psav.com/cPaper2012/myitinerary/index.php?congress=ats2013

  251. A Randomized, Placebo-controlled, Parallel Panel Study to Assess the Effects of REGN3500, Dupilumab, and Combination of REGN3500 Plus Dupilumab on Markers of Inflammation After Bronchial Allergen Challenge in Patients With Allergic Asthma

    ctiprofile

  252. Regeneron Pharmaceuticals. Internet-Doc 2020;.

    Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/872589/000153217620000008/regn-123119x10k.htm

  253. Dupilumab USFDA orphan drug. Internet-Doc 2020;.

    Available from: URL: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=697319

  254. An Open-Label, Expanded Access Program of Dupilumab in Adult Patients With Bullous Pemphigoid

    ctiprofile

  255. Phase 3 study of dupilumab in the patients with bullous pemphigoid

    ctiprofile

  256. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

    ctiprofile

  257. A Phase 2/3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

    ctiprofile

  258. Dellon E, Rothenberg M, Che-hade M, Mortensen E, Laws E, Maloney J, et al. A Phase 2/3 Study To Assess The Efficacy And Safety Of Dupilumab Versus Placebo In AdultsAnd Adolescents With Eosinophilic GastritisWith Or Without Eosinophilic Duodenitis. AAAAI-2024 2024; abstr. 621.

    Available from: URL: https://annualmeeting.aaaai.org/

  259. A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti-IL4a) in Subjects With Eosinophilic Gastritis

    ctiprofile

  260. Press Release: Dupixent(Rm) FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EoE).

    Media Release

  261. Dupixent(Rm) (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE).

    Media Release

  262. Press Release: Dupixent(Rm) (dupilumab) sBLA for treatment of eosinophilic esophagitis in children aged 1 to 11 accepted for FDA Priority Review.

    Media Release

  263. FDA Approves Dupixent(R)(dupilumab) as First Treatment for Adults and Children Aged 12 and Older with Eosinophilic Esophagitis.

    Media Release

  264. Press Release: FDA accepts Dupixent(Rm) (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis.

    Media Release

  265. Dupixent(Rm) (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis.

    Media Release

  266. DUPIXENT(Rm) (dupilumab injection) is now approved in Canada for the treatment of adult and adolescent patients (12+) with Eosinophilic Esophagitis.

    Media Release

  267. Press Release: Dupixent(Rm) (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis.

    Media Release

  268. Sanofi and Regeneron Announce Positive Phase 2 Study Results for Dupilumab in Patients With Active Moderate-to-Severe Eosinophilic Esophagitis.

    Media Release

  269. Dupixent(R) (dupilumab) Late-Breaking Phase 3 Data Presented at UEG Week 2022 Showed Significant Histological Remission of Eosinophilic Esophagitis (EoE) in Children 1 to 11 Years Old.

    Media Release

  270. Press Release: Dupixent(R) (dupilumab) late-breaking Phase 3 data presented at UEG Week 2022 showed significant histological remission of eosinophilic esophagitis (EoE) in children 1 to 11 years old.

    Media Release

  271. A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis

    ctiprofile

  272. Dupixent(R)(dupilumab) Phase 3 Trial Shows Positive Results in Children 1 to 11 Years of Age with Eosinophilic Esophagitis.

    Media Release

  273. Press Release: Dupixent(R) (dupilumab) Phase 3 Results show sustained efficacy for up to one year in children 1 to 11 years of age with eosinophilic esophagitis (EoE).

    Media Release

  274. MirnaChehade, EvanDellon, JonathanSpergel, Rothenberg M, RobertPesek, Collins M, et al. Dupilumab Improves Histologic And Endoscopic Outcomes In Children Aged 1 To <12 Years With Eosinophilic Esophagitis (EoE): 52-Week Results From The Phase 3 EoE KIDS Trial. AAAAI-2024 2024; abstr. 821.

    Available from: URL: https://annualmeeting.aaaai.org/

  275. Rothenberg M, Lim WK, Wipperman M, Chehade M, Dellon E, Hundal NV, et al. Dupilumab Normalized The Expression Of GenesDysregulated In Eosinophilic Esophagitis (EoE)In Esophageal Biopsies From A Clinical TrialOf Children Aged 1-11 Years. AAAAI-2024 2024; abstr. 458.

    Available from: URL: https://annualmeeting.aaaai.org/

  276. Bredenoord A, Dellon ES, Lucendo AJ, Collins MH, Sun X, Nag A, et al. Dupilumab Improves Clinical, Symptomatic, Histologic, and Endoscopic Aspects of Eoe, Regardless of Prior Swallowed Topical Steroid Use. UEGW-2022 2022; abstr. OP076.

    Available from: URL: https://ueg.eu/week

  277. Late-breaking data at 2022 AAAAI Annual Meeting show Dupixent(R)(dupilumab) significantly improved signs and symptoms of eosinophilic esophagitis.

    Media Release

  278. Rothenberg M, Dellon E, Bredenoord A, Collins M, Hirano I, Chehade M, et al. Dupilumab Improves Clinical and Histologic Aspects of Disease in Adult and Adolescent Patients With Eosinophilic Esophagitis at Week 24: Results from Part B of the 3-Part LIBERTY EoE TREET Study. AAAAI-2022 2022; abstr. L02.

    Available from: URL: https://annualmeeting.aaaai.org/

  279. Second Dupixent(Rm) (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2 inflammation in this complex disease.

    Media Release

  280. Dupixent(Rm) (dupilumab) late-breaking pivotal data showing significant improvement in eosinophilic esophagitis signs and symptoms presented for the first time at scientific meetings.

    Media Release

  281. Dellon E, Rothenberg M, Hirano I, Chehade M, Bredenoord AJ, Spergel J-t, et al. Dupilumab Improves Health-Related Quality of Life (HRQoL) and Reduces Symptom Burden in Patients with Eosinophilic Esophagitis (EoE): Results From Part A of a Randomized, Placebo- Controlled Three-Part Phase 3 Study. AAAAI-2021 2021; abstr. 290.

    Available from: URL: https://annualmeeting.aaaai.org/

  282. Dellon E S, Rothenberg M E, Collins M H, Hirano I, Chehade M, Bredenoord A, et al. Dupilumab Efficacy and Safety in Adult and Adolescent Patients with Eosinophilic Esophagitis: Results from Part a of a Randomized, Placebo-Controlled Three-Part, Phase 3 Study. UEGW-2020 2020; abstr. LB22.

    Available from: URL: https://www.professionalabstracts.com/ueg2020/iplanner/

  283. Dupixent(Rm) (dupilumab) eosinophilic esophagitis trial meets both co-primary endpoints.

    Media Release

  284. A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

    ctiprofile

  285. Dellon E, Rothenberg M, Hirano I, Brendenoord A, Lucendo A, Sun X, et al. Dupilumab Improves Clinical, Symptomatic, Histologic, Endoscopic Aspects of EoE: Pooled Results from Phase 3 LIBERTY-EoE-TREET. ACAAI-2022 2022; abstr. P047.

    Available from: URL: https://epostersonline.com/acaai2022/poster/p047

  286. Spergel J, Sher L, Durrani S, Dellon E, Rothenberg M, Sun X, et al. Dupilumab improves type 2 comorbidity outcomes in patients with eosinophilic esophagitis and comorbid disease at baseline: from Parts A and B of LIBERTY-EoE-TREET. AAAAI-2023 2023; abstr. 614.

    Available from: URL: https://annualmeeting.aaaai.org/

  287. Collins M. Dupilumab Reduced Eosinophil Counts and Improved Hss Grade and Stage Scores in Patients with Eosinophilic Esophagitis: Liberty-Eoe-Treet Phase 3 Study Parts a and B. DDW-2023 2023; abstr. Sa1274.

    Available from: URL: https://eposters.ddw.org/ddw/2023/ddw-2023/378644/margaret.collins.dupilumab.reduced.eosinophil.counts.and.improved.hss.grade.html?f=menu%3D16%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D2482%2Aot_id%3D27745%2Atrend%3D19514%2Amarker%3D4154

  288. Hirano I. Dupilumab Improves Inflammatory and Remodeling Aspects of Endoscopic Disease Activity in Eosinophilic Esophagitis: Results from the Phase 3 Liberty-Eoe-Treet Study. DDW-2023 2023; abstr. Sa1270.

    Available from: URL: https://eposters.ddw.org/ddw/2023

  289. Dellon E. Dupilumab Treatment Reduces the Frequency of Dysphagia Days and Actions to Relieve Dysphagia in Patients with Eosinophilic Esophagitis: Results from the Phase 3 Liberty-Eoe-Treet Study. DDW-2023 2023; abstr. Sa1294.

    Available from: URL: https://eposters.ddw.org/ddw/2023

  290. Bredenoord A, Dellon ES, Hirano I, Lucendo AJ, Schlag C, Sun X, et al. Efficacy of Dupilumab in Patients with Eosinophilic Esophagitis and Prior use or Prior Inadequate Response, Intolerance, or Contraindication to Swallowed Topical Corticosteroids: Results from Part C of the Liberty Eoe Treet Study . UEGW-2023 2023; abstr. MP482.

    Available from: URL: https://ueg.eu/week

  291. Dellon ES, Rothenberg ME, Collins MH, Hirano I, Chehade M, Bredenoord AJ, et al. Dupilumab Efficacy and Safety Up to 52 Weeks in Adult and Adolescent Patients with Eosinophilic Esophagitis: Results from Parts B and C of the Randomized, Placebo-Controlled, Three-Part, Phase 3 Liberty Eoe Treet Study . UEGW-2023 2023; abstr. OP162.

    Available from: URL: https://ueg.eu/week

  292. A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients With Active Eosinophilic Esophagitis

    ctiprofile

  293. Dupilumab in Severe Chronic Hand Eczema With Inadequate Response or Intolerance to Alitretinoin

    ctiprofile

  294. Voorberg AN, Kamphuis E, Christoffers WA, Schuttelaar MLA. Efficacy and safety of dupilumab in patients with severe chronic hand eczema with inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled phase IIb proof-of-concept study. Br-J-Dermatol 2023;.

    PubMed | CrossRef Fulltext

  295. Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER.

    Media Release

  296. A Study To Evaluate The Efficacy Of Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy To Reduce Provoked Allergic Rhinitis Symptoms Using The Nasal Allergen Challenge Model

    ctiprofile

  297. A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

    ctiprofile

  298. Aimmune Therapeutics Announces Initiation of Phase 2 Study With Regeneron and Sanofi of AR101 With Adjunctive Dupilumab in Peanut-Allergic Patients.

    Media Release

  299. A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)

    ctiprofile

  300. Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

    ctiprofile

  301. FDA approves first treatment for chronic rhinosinusitis with nasal polyps.

    Media Release

  302. FDA to Undertake Priority Review of Dupixent(R) (dupilumab) for Adults with Inadequately Controlled Severe Chronic Rhinosinusitis with Nasal Polyps.

    Media Release

  303. Sanofi: FDA to undertake priority review of Dupixent(Rm) (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps.

    Media Release

  304. Regeneron Reports Fourth Quarter and Full Year 2018 Financial and Operating Results.

    Media Release

  305. Sanofi : Dupixent(Rm) (dupilumab) now approved in European Union for severe chronic rhinosinusitis with nasal polyposis.

    Media Release

  306. CHMP Recommends Approval of Dupixent(Rm) (dupilumab) for Severe Chronic Rhinosinusitis with Nasal Polyposis.

    Media Release

  307. Regeneron Reports First Quarter 2019 Financial and Operating Results.

    Media Release

  308. DUPIXENT(Rm) (dupilumab injection) now approved by Health Canada for severe chronic rhinosinusitis with nasal polyposis.

    Media Release

  309. Regeneron Reports First Quarter 2020 Financial and Operating Results.

    Media Release

  310. The Lancet Publishes Results from Two Positive Phase 3 Trials of Dupixent(Rm) (dupilumab) in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

    Media Release

  311. A Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab, in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) on a Background Therapy With Intranasal Corticosteroids

    ctiprofile

  312. Bachert C, Han JK, Desrosiers M, Hellings PW, Mao X, Zhang M, et al. Dupilumab Improves Asthma Control as Assessed by Total and Individual Item Scores of the 6-Item Asthma Control Questionnaire in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps and Comorbid Asthma: Pooled Results from the SINUS-24 and SINUS-52 Phase 3 Studies. ATS-2020 2020; abstr. 705.

    Available from: URL: https://www.abstractsonline.com/pp8/#!/8998/presentation/8313

  313. Mullol J, Han J, Bosso J, Mannent L, Amin N, Cho S, et al. Dupilumab Treatment Improves Sense of Smell in Patients With Chronic Rhinosinusitis With Nasal Polyps - Pooled Results From the SINUS-24 and SINUS-52 Phase 3 Trials. AAAAI-2020 2020; abstr. 545.

    Available from: URL: http://annualmeeting.aaaai.org/

  314. Positive Results Presented from Two Phase 3 Trials of Dupixent(R) (dupilumab) in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

    Media Release

  315. Laidlaw T, Cho S, Maspero JF, Canonica GW, Sher L, Bachert C, et al. Dupilumab Improves Upper and Lower Airway Outcome Measures in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps and Comorbid Asthma: Pooled Results from the SINUS-24 and SINUS-52 Phase 3 Studies. ATS-2019 2019; abstr. A7356.

    Available from: URL: http://link.adisinsight.com/Yn29P

  316. Gevaert P, Lee SE, Settipane R, Wagenmann M, Msihid J, Siddiqui S, et al. Dupilumab Provides Early and Durable Improvement of Symptoms in Patients with Chronic Rhinosinusitis with Nasal Polyps: Results from the SINUS-24 and SINUS-52 Phase 3 Trials. ATS-2021 2021; abstr. A1341.

    Available from: URL: https://conference.thoracic.org/program/abstract-search.php?sid=P6070

  317. Hellings PW, Peters A, Chaker AM, Heffler E, Zhang H, Daizadeh N, et al. Rapid and Sustained Effects of Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps: Analysis of the SINUS-24 and SINUS-52 Phase 3 Trails. ATS-2021 2021; abstr. A1345.

    Available from: URL: https://conference.thoracic.org/program/abstract-search.php?sid=P6074

  318. A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

    ctiprofile

  319. A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

    ctiprofile

  320. Bachert C, Cho S, Laidlaw T, Swanson B, Harel S, Mannent L, et al. Dupilumab Reduces Blood, Urine, and Nasal Biomarkers of Type 2 Inflammation in Patients With Chronic Rhinosinusitis With Nasal Polyps in the Phase 3 SINUS-52 Trial. AAAAI-2020 2020; abstr. 594.

    Available from: URL: http://annualmeeting.aaaai.org/

  321. Laidlaw TM, Mullol J, Canonica GW, Bachert C, Han JK, Zhang M, et al. Dupilumab (DPL) Improves Upper and Lower Airway Outcomes in Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) with Nonsteroidal Anti-inflammatory Drug-Exacerbated Respiratory Disease (NSAID-ERD): Pooled Results From SINUS-24, SINUS-52 Phase 3 Trials. ERS-2019 2019; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/54/suppl_63/PA539

  322. Mullol J, Laidlaw TM, Amin N, Bachert C, Han JK, Hellings PW, et al. Dupilumab (DPL) Efficacy in Patients With Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with/without Nonsteroidal Anti-inflammatory Drug-Exacerbated Respiratory Disease (NSAID-ERD): SINUS-24, SINUS-52 Trials. ERS-2019 2019; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/54/suppl_63/RCT3783

  323. Sanofi: Dupixent(R) (dupilumab) showed positive topline results in two Phase 3 trials of patients with chronic rhinosinusitis with nasal polyps.

    Media Release

  324. Bachert C, Peters A, Hef?er E, Han J, Olze H, Pfaar O, et al. A Responder Analysis To Demonstrate Dupilumab Treatment Effect Across Objective and Patient-Reported Subjective Endpoints For Patients with Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). AAAAI-2021 2021; abstr. 423.

    Available from: URL: https://annualmeeting.aaaai.org/

  325. Bachert C, Khan A, Fokkens W, Hopkins C, Gevaert P, Han J, et al. Onset, Maintenance, and Durability of Response with Dupilumab in Chronic Rhinosinusitis with Nasal Polyps. ERS-2022 2022; abstr. N/A.

    Available from: URL: https://erj.ersjournals.com/content/60/suppl_66/1711

  326. Han J, Gross G, Mannent L, Amin N, Cho S, Bachert C. Dupilumab Improves Sinus Opacification in All Sinuses in Patients With Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP): Results From the SINUS-24 Phase 3 Study. AAAAI-2020 2020; abstr. 814.

    Available from: URL: http://annualmeeting.aaaai.org/

  327. Regeneron Reports Third Quarter 2014 Financial and Operating Results.

    Media Release

  328. Regeneron and Sanofi Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps.

    Media Release

  329. Sanofi and Regeneron Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps.

    Media Release

  330. Bachert C, Hellings P, Mullol J, Hamilos D, Naclerio R, Joish VN, et al. Dupilumab improves patient-reported outcomes in chronic sinusitis with nasal polyps patients with comorbid asthma: Results from a phase 2a trial. ERS-2016 2016; abstr. OA251.

    Available from: URL: http://link.adisinsight.com/Xt4y7

  331. A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis

    ctiprofile

  332. A Randomized, 52-week Treatment Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray

    ctiprofile

  333. A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Uncontrolled, Chronic Rhinosinusitis Without Nasal Polyposis (CRSsNP)

    ctiprofile

  334. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab and Milk Oral Immunotherapy for the Treatment of Patients With Cow's Milk Allergy

    ctiprofile

  335. A Randomized, Double-blind, Placebo-controlled, Multicenter, 16-week Treatment Study With a 16 Week Follow-up Period to Assess the Efficacy and Safety of Dupilumab (Anti-IL4Ra) in Adult Patients With Cholinergic Urticaria Despite H1-antihistamine Treatment

    ctiprofile

  336. Press Release: Dupixent(Rm) (dupilumab) approved by European Commission as the first and only targeted medicine indicated for prurigo nodularis.

    Media Release

  337. Dupixent(Rm) (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Prurigo Nodularis.

    Media Release

  338. Dupixent(R) (dupilumab) Approved by FDA as the First and Only Treatment Indicated for Prurigo Nodularis.

    Media Release

  339. FDA Accepts Dupixent(Rm) (dupilumab) for Priority Review in Adults with Prurigo Nodularis.

    Media Release

  340. Press Release: Dupixent(Rm) (dupilumab) recommended for EU approval by the CHMP for the treatment of prurigo nodularis.

    Media Release

  341. Regeneron Reports Second Quarter 2022 Financial and Operating Results.

    Media Release

  342. Press Release: Dupixent(Rm) (dupilumab) late-breaking Phase 3 data at EADV 2022 showed significant improvements in signs and symptoms of prurigo nodularis.

    Media Release

  343. Kwatra SG, Yosipovitch G, Stander S, Guillemin I, Msihid J, Wiggins S, et al. Dupilumab Improves Itch, Skin Pain, and Sleep in Adult Patients With Prurigo Nodularis (LIBERTY PN-PRIME and PRIME2). AAD-2023 2023; abstr. 42275.

    Available from: URL: https://eposters.aad.org/abstracts/42275

  344. Bahloul D, Thomas RB, Rhoten S, Wratten S, Stander S, Kim BS, et al. Validation of the skin pain numeric rating scale (NRS) in prurigo nodularis (PN) based on clinical studies of dupilumab in adults with PN. AAD-2023 2023; abstr. 42895.

    Available from: URL: https://eposters.aad.org/abstracts/42895

  345. A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

    ctiprofile

  346. A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

    ctiprofile

  347. Second positive Phase 3 Dupixent(Rm) (dupilumab) trial confirms significant improvements for patients with prurigo nodularis.

    Media Release

  348. Dupixent(Rm) (dupilumab) is the first biologic to significantly reduce itch and skin lesions in Phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease.

    Media Release

  349. Master protocol of two randomized, double blind, placebo-controlled, multicenter, parallel group studies to evaluate the efficacy and safety of dupilumab in adult patients with chronic pruritus of unknown origin (CPUO)

    ctiprofile

  350. A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Evaluate the Efficacy and Safety of Dupilumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype

    ctiprofile

  351. Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study

    ctiprofile

  352. A Randomized, Open-label, Parallel Design, Single Dose Study to Compare the Pharmacokinetics of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults

    ctiprofile

  353. A Randomized, Open-label, Parallel Design Study of the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products After Administration of Single Subcutaneous Doses

    ctiprofile

  354. Study of the safety, tolerability, pharmacokinetics and immunogenicity of REGN-668 administered subcutaneously to healthy volunteers.

    ctiprofile

  355. A Randomized, Open-label, Parallel Design Study of the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products After Administration of Single Subcutaneous Doses

    ctiprofile

  356. A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Subcutaneous Doses of SAR231893/REGN668 in Healthy Japanese Adult Male Subjects

    ctiprofile

  357. A Randomized, Double-Blind, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of Two Different SAR231893 Drug Products After Administration of a Single Subcutaneous Dose to Healthy Subjects.

    ctiprofile

  358. Regeneron Reports Second Quarter 2010 Financial and Operating Results.

    Media Release

  359. A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study of the Safety and Tolerability of Intravenously Administered REGN668 in Healthy Volunteers

    ctiprofile

  360. Sanofi 20F March 2023. Internet-Doc 2023;.

    Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1121404/000112140423000008/sny-20221231.htm

  361. Regenration pharmaceuticals 10-K, Dec 2021. Internet-Doc 2022;.

    Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/872589/000180422022000007/regn-20211231.htm

  362. Regeneron Pharmaceuticals SEC. Internet-Doc 2021;.

    Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/872589/000180422021000008/regn-20201231.htm

  363. Regeneron Pharmaceuticals SEC filing, FORM - 10K. Internet-Doc 2018;.

    Available from: URL: https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-123117x10k.htm

  364. U.S. and EU Patent Office Decisions Invalidate Amgen Subsidiary Immunex's Patents Claiming Antibodies to the IL-4 Receptor.

    Media Release

  365. SEC filing-Sanofi, April 2022. Internet-Doc 2022;.

    Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1121404/000112140422000007/sny-20211231.htm

  366. Maurer M, Casale TB, Saini SS, Ben-Shoshan M, Radin A, Bauer D, et al. Dupilumab Improves Urticaria Signs and Symptoms and Quality of Life in Patients With Chronic Spontaneous Urticaria (CSU). AAD-2023 2023; abstr. 42011.

    Available from: URL: https://eposters.aad.org/abstracts/42011

  367. Press Release: Positive Dupixent(Rm) (dupilumab) Phase 3 results in adults and adolescents with eosinophilic esophagitis published in the New England Journal of Medicine.

    Media Release

  368. Dellon ES, Rothenberg ME, Collins MH, Hirano I, Chehade M, Bredenoord AJ, et al. Dupilumab Efficacy and Safety Up to 52 Weeks in Adult and Adolescent Patients with Eosinophilic Esophagitis: Results from Part a and C of a Randomized, Placebo-Controlled, Three-Part, Phase 3 Liberty Eoe Treet Study. UEGW-2021 2021; abstr. LB10.

    Available from: URL: https://programme.ueg.eu/week2021/#/details/presentations/4923

  369. Regeneron Reports Third Quarter 2019 Financial and Operating Results.

    Media Release

  370. Regeneron Reports Second Quarter 2018 Financial and Operating Results.

    Media Release

  371. Sanofi: Q2 2018 Performance Positions Sanofi for New Growth Phase.

    Media Release

  372. NICE Recommends Sanofi's New Treatment Dupixent(R) (dupilumab) for Adults with Moderate to Severe Atopic Dermatitis in England[1].

    Media Release

  373. Sanofi Delivers 2017 Business EPS(1) in line with Guidance.

    Media Release

  374. Regeneron Collaboration Programs Highlighted During Sanofi Analyst Day.

    Media Release

  375. Sanofi : Q3 2017 Business EPS up 1.1% at CER FY 2017 Guidance Confirmed.

    Media Release

  376. Regeneron Reports Second Quarter 2017 Financial and Operating Results.

    Media Release

  377. Regeneron and Sanofi Announce Positive Dupilumab Topline Results from Two Phase 3 Trials in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients.

    Media Release

  378. Swanson BN, Teper A, Hamilton JD, Zhang B, Staudinger H, Tian N, et al. Dupilumab Suppresses Fractional Exhaled Nitric Oxide (FeNO) and Biomarkers of Type 2 Inflammation in Adult Patients with Persistent Uncontrolled Asthma Despite Use of Medium-to-High Dose Inhaled Corticosteroids Plus Long-Acting Beta-Agonists (ICS/LABAs). AAAAI-2016 2016; abstr. 620.

    Available from: URL: http://link.adisinsight.com/p4S6C

  379. Sanofi : FDA approves Dupixent(Rm) (dupilumab) for chronic rhinosinusitis with nasal polyposis.

    Media Release

  380. An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis

    ctiprofile

  381. Sanofi: New England Journal of Medicine publishes two positive Phase 3 trials showing Dupixent(R) (dupilumab) improved moderate-to-severe asthma.

    Media Release

  382. Dupixent(R) (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age with Eosinophilic Esophagitis (EoE).

    Media Release

  383. Sanofi and Regeneron Announce Positive Dupilumab Topline Results From Phase 3 Trial in Uncontrolled Persistent Asthma.

    Media Release
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