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Erenumab - Amgen/Novartis

Drug Profile

Erenumab - Amgen/Novartis

Alternative Names: Aimovig; AMG-334; Erenumab-aooe

Latest Information Update: 06 Feb 2024

At a glance

  • Originator Amgen
  • Developer Amgen; Indiana University; Novartis; Rigshospitalet
  • Class Antimigraines; Monoclonal antibodies
  • Mechanism of Action Calcitonin gene-related peptide receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Migraine
  • Phase II Headache; Rosacea; Temporomandibular joint dysfunction syndrome; Trigeminal neuralgia
  • Discontinued Hot flashes

Most Recent Events

  • 19 Jan 2024 Indiana University in collaboration with Novartis Pharmaceuticals completes a phase II trial in Temporomandibular joint dysfunction syndrome (In adults) in USA (SC) (NCT04884763)
  • 28 Feb 2023 Amgen has patent protection for erenumab in USA
  • 03 Jan 2023 Amgen terminates the phase II TMD CARE trial for Temporomandibular joint dysfunction syndrome in USA (SC) due to low enrolment rate (NCT05162027)

Development Overview

Introduction

Erenumab is a fully human monoclonal antibody that acts as a calcitonin gene-related peptide (CGRP) receptor antagonist, being developed by Amgen and Novartis, for the prevention of migraine and post-traumatic headache, and for the treatment of temporomandibular disorder [Temporomandibular joint dysfunction syndrome in development table]. CGRP is expressed throughout the peripheral and central nervous system, where it is involved in controlling vasodilation and transmission of nociceptive information. Its vasodilatory effects play a key role in migraine pathophysiology, and are also thought to be involved in the development of hot flashes in menopausal women. The drug is launched in Canada, the EU, Iceland, Liechtenstein, Norway, Switzerland, the US, Spain and is approved in Australia, Singapore, Japan and United Arab Emirates. Erenumab formulated as 140mg injection is approved for prevention of migraine in the US. Clinical development for migraine, trigeminal neuralgia, headache and rosacea, temporomandibular joint dysfunction syndrome, is underway in multiple countries.

Development for hot flashes was discontinued in the US and for migraine in Belgium.

Erenumab was the first lead product to arise out of Amgen's CGRP-antagonist research programme [see AdisInsight Drug profile 800036728].

As at June 2021, no recent reports of development had been identified for phase-I development in Migraine (In adolescents, In children) in USA.

Company Agreements

As of January 2022, Novartis retains the ex-US Novartis rights and will continue to pay double-digit royalties on net sales in the ex-U.S. Novartis Rights territories. In the United States, Novartis will no longer collaborate with Amgen, share erenumab (Aimovig®) commercialization costs or pay milestones and Amgen will no longer pay royalties to Novartis on sales of erenumab (Aimovig®). Amgen and Novartis will continue to share development expenses worldwide. Amgen will manufacture and supply erenumab (Aimovig®) worldwide. In April 2019, Amgen issued a notice of termination of the collaboration agreement with Novartis for erenumab (Aimovig®). Amgen claimed that the notice was issued due to material breach of the collaboration agreement. Following this, Novartis filed a lawsuit to confirm the legal merit of Amgen’s right to terminate the agreement. Hence, the collaboration will not be terminated until the final announcement of court’s decision. Earlier in April 2017, Amgen had expanded its commercial collaboration with Novartis for erenumab. The companies agreed to co-commercialise erenumab in the US. Amgen retained exclusive commercialisation rights in Japan. Novartis gained exclusive rights to commercialise erenumab in Canada, and retained its existing commercialisation rights in rest of the world. The companies will continue global co-development. Under the terms of the agreement, Amgen will receive milestone payments from Novartis. Novartis will share US commercialisation costs with Amgen. Amgen will book sales of erenumab in the US, and will pay a royalty to Novartis on net sales in the US. Novartis will book sales in the rest of the world, excluding Japan, and will pay Amgen royalties on the net sales in those countries. Amgen will book sales in Japan, since it will remain an exclusive territory for the Company. Novartis will assume agreed upon remaining global development costs up to a cap and share global development costs thereafter. In September 2015, Amgen entered into the global co-commercialisation and co-development collaboration with Novartis in the areas of Alzheimer's disease and migraine. Novartis BACE inhibitor, CNP 520, was to be the lead molecule and each company's pre-clinical BACE (beta-site APP-cleaving enzyme-1) inhibitor programmes will be potential follow-ons. Amgen will make upfront and milestone payments, and will be responsible for disproportional research and development costs for an agreed-upon period followed by a 50/50 cost and profit share arrangement. Novartis will receive global co-development rights and commercial rights outside of the US, Canada and Japan to Amgen's migraine portfolio programme, including AMG 334 and AMG 301, as well as an option to commercialise an additional early-stage Amgen molecule in these territories. In exchange for territory rights, Novartis will fund disproportional amounts of the global R&D expenses for an agreed-upon period on the migraine programmes and pay Amgen double-digit royalties on sales. [1] [2] [3]

Key Development Milestones

Migraine

In March 2019, the US FDA approved the use of erenumab formulated single-dose 140 mg Sureclick®autoinjector device and 140 mg prefilled syringe for prevention of migraine. An a supplemental BLA seeking approval was submitted earlier in June 2018 by Amgen [4] [5] .

In February 2020, an independent appeal panel ruled that it was required of the National Institute for Health and Care Excellence (NICE), to request evidence-based data establishing the effectiveness of erenumab, in a subgroup of patients with chronic migraine. The independent appeal panel upheld one appeal point, which was that the committee unreasonably failed to consider the cost-effectiveness of erenumab, as opposed to the best supportive care in people with chronic migraine who could not benefit from the comparator drug (botulinum toxin) or when it was contra-indicated. The appeal was submitted jointly by the British Association for the Study of Headache and the Association of British Neurologists against the final draft guidance (FAD) for erenumab, which did not recommend the drug, within its marketing authorisation, for prevention of migraine in adults who had a minimum of four migraine days per month. The appeal panel also dismissed other points in the appeal, in December 2019. Earlier, in January 2019, Novartis reported that NICE in its initial decision, did not recommend the routine usage of erenumab on the National Health Service (NHS), for the prevention of migraine in adults. NICE announced that the evidence showed erenumab as a clinically effective treatment. However, the clinical trial evidence for the drug did not fully reflect patients seen in the NHS, nor did it include all the relevant comparisons with other drugs and outcomes. Hence, the cost-effectiveness estimates for erenumab were higher than what NICE deemed as acceptable when there was substantial uncertainty in the evidence. Moreover, there was not enough evidence to suggest that it was more effective than botulinum toxin type A for people with chronic migraine, which NICE already recommends. Also, there was no evidence to show that erenumab was effective in the long-term in people for whom three previous preventive measures had failed for both the chronic and episodic migraine populations [6] [7] [8] .

In October 2018, Novartis announced that erenumab was approved for migraine in Singapore and the United Arab Emirates [9] .

In July 2018, erenumab (Aimovig™) was launched in the US following approval from the US FDA in May 2018, for its use as an once-monthly self-injection for the prevention of migraine in adults. Erenumab 70mg is to be self-administered once monthly via Amgen's SureClick® autoinjector, and does not require a loading dose. The approval was based on three clinical trials [see below] [10] [11] . In July 2017, a Biologics License Application (BLA) for erenumab was filed with the US FDA. The US FDA had assigned a PDUFA date of May 17, 2018 [12] [13] [14] [15] [16] .

In December 2018, Novartis launched erenumab (Aimovig®) for the prevention of migraine in adults who have at least four migraine days per month as a self-administered, once-monthly injection via Amgen's SureClick® autoinjector in Canada [17] . In August 2018, erenumab (Aimovig®) was approved by Health Canada [18] .

In third quarter of 2018, Novartis launched erenumab for the prevention of migraine in adults in Europe [19] . In July 2018, the European Medicines Agency (EMA), the Swissmedic and the Australian TGA approved erenumab for the prevention of migraine in adults. In June 2018, Novartis received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending approval for the product. The CHMP positive opinion was based on a robust data package, including four phase II and phase III clinical studies of more than 2600 patients with migraine. In June 2017, a Marketing Authorisation Application (MAA) was filed with the European Medicines Agency (EMA) [20] [21] [22] [15] .

In June 2021, Amgen announced that the Japanese Ministry of Health, Labour and Welfare granted marketing approval for Aimovig® (erenumab) for the suppression of onset of migraine attacks in adults. The approval is based on results from phase II (20120309) and phase III (20170609) trial [see below]. Earlier in September 2020, Amgen submitted a marketing authorization application with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for erenumab for the prevention of migraine [23] [24] .

In April 2022, pooled adverse events data from a phase II and III trial in migraine presented at the 74th Annual Meeting of the American Academy of Neurology 2022 (AAN-2022) [25]

In June 2021, pooled data from phase II (20120309) and phase III (20170609) trial [see below], released by Amgen [23]

In September 2019, Amgen initiated the phase III (OASIS (CM)) trial to evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine (NCT03832998; 20160354; P370-2016; EudraCT2017-002399-23). The randomised, double blind trial intends to enrol 286 participants in the US, Belgium, Finland, Hungary, Italy, Japan, United Kingdom, Canada, Germany, Poland [26] .

In July 2019, Amgen initiated a phase III trial (OASIS PEDIATRIC [EM]) to evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine (NCT03836040; 20150125; EudraCT2017-002397-39).The randomised, parallel assignment trial intends to enrol 456 participants in the US, Belgium, Finland, Hungary, Switzerland, United Kingdom, Canada, Germany, Poland, Japan, Italy and may expand to other countries [27] .

In November 2020, Amgen completed a phase III trial to evaluate safety and efficacy of erenumab for prevention of migraine in Japanese patients with episodic migraine and chronic migraine (20170609; NCT03812224). The randomised, double-blind trial was initiated in April 2019 and enrolled 261 patients in Japan [28] . As of June 2021, patients treated with erenumab saw a reduction from baseline in their monthly migraine days [23] .

In January 2020, Novartis Pharmaceuticals completed the phase III EMPOwER trial that evaluated the efficacy and safety of erenumabin countries beyond the US and the EU (CAMG334A2302; NCT03333109). The double-blind, parallel, prospective, randomized trial was initiated in February 2018 and enrolled 900 patients in Argentina, India, Mexico, Philippines, Vietnam, South Korea, Lebanon, Malaysia, Singapore, Taiwan and Thailand [29] . In April 2022, Novartis presented results from the trial at the 74th Annual Meeting of the American Academy of Neurology 2022 (AAN-2022) [30]

In January 2018, Novartis reported that the phase III LIBERTY trial met the primary endpoint of percentage of patients treated with erenumab who achieved at least 50% reduction of migraine days compared to placebo including the secondary endpoints (CAMG334A2301; EudraCT2016-002211-18; NCT03096834). In January 2021, Novartis Pharmaceuticals completed phase III LIBERTY trial that was designed to evaluate the efficacy and safety of once monthly subcutaneous injection of erenumab 70mg in adult patients with episodic migraine who have failed 2-4 prophylactic treatments. The open label, double-blind, randomised trial which initiated in March 2017 and enrolled 247 patients in Australia, Austria, Belgium, Czech, Denmark, Finland, France, Germany, Greece, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland and the UK. The trial includes a 156 weeks open label extension phase (OLEP) to evaluate the long-term efficacy of erenumab. The OLEP includes patients who completed the 12-week double-blinded treatment phase (DBTP). Initial data from the study were released in October 2018. Updated efficacy data from the OLEP of the trial were released in July 2019. In May 2019, results from the study were presented at the 71st Annual Meeting of the American Academy of Neurology (AAN-2019) [31] [32] [9] [33] [34] [35] [36] . In October 2020, Amgen announced two-year data of phase III trial that showed sustained efficacy and no increases in adverse events rates [37] . In April 2022, Updated safety and efficacy data from the trial were presented at the 74th Annual Meeting of the American Academy of Neurology 2022 (AAN-2022) [38] .

In November 2016, Amgen reported that the phase III STRIVE trial met its primary endpoint demonstrating statistically significant reductions from baseline in monthly migraine days in patients with episodic migraine treated with either 70mg or 140mg erenumab, when compared with placebo (20120296; NCT02456740; EudraCT2014-004464-38). The randomised, double-blind, placebo-controlled trial was initiated in July 2015, and enrolled 955 patients in the US, Austria, Belgium, Canada, Czech Republic, Finland, Germany, Hungary, Netherlands, Sweden, Slovakia, Poland, Turkey and the UK. The trial was completed in June 2017. The comparative results from the trial that demonstrated a safety profile synonymous with that observed in previous trials, were released in May 2019. In May 2019 and June 2019, Novartis released and presented the updated 52-week data from the trial that exhibited erenumab reduced acute migraine medication days by half in patients, who failed prior preventions at the 71st Annual Meeting of the American Academy of Neurology [39] [40] [41] [42] [43] [44] [45] .

In March 2017, Amgen completed the randomised, double-blind, phase III trial that evaluated the effect of erenumab on the change from baseline in monthly migraine days, in patients with episodic migraine (ARISE; 20120297; NCT02483585; EudraCT2014-004463-20). The trial was initiated in July 2015 and enrolled 577 patients in the US, Denmark, France, Greece, Portugal, Russia, Spain and Switzerland [46] . In September 2016, Amgen reported that the phase III ARISE study had met its primary end point by achieving significant reduction from baseline in monthly migraine days in patients with episodic migraine compared with a placebo at 12 weeks [47] [48] .

In August 2019, Novartis initiated a phase III DRAGON trial to evaluate the safety and efficacy of subcutaneous erenumab in adult patients with migraine (CTRI2020-09-027647; CAMG334A2304; NCT03867201). The randomized and double blind study is designed to enrol approximately 550 patients in China, India, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam and South Korea. In April 2022, results from the trial were presented at the 74th Annual Meeting of the American Academy of Neurology 2022 (AAN-2022) [49] [50] .

In October 2021, Danish Headache Center (a department in Rigshospitalet), completed its phase II proof-of-concept study that evaluated the efficacy and tolerability of erenumab in patients with trigeminal neuralgia (H-19011013; NCT04054024). The randomised, double blind trial was initiated in October 2019 and enrolled 80 patients in Dentmark [51] .

In January 2015, Amgen completed the randomised, double-blind, placebo-controlled phase IIb trial which evaluated the efficacy and safety of subcutaneous doses of erenumab in the prevention of chronic episodic migraine (20120178; NCT01952574; EudraCT2012-005331-90). The primary endpoint was the change in monthly migraine days from baseline, assessed from weeks 9 to 12. The 12-week trial enrolled 484 patients in the US, Canada, Denmark, Finland, Germany, Sweden and Norway [52] [53] . Patients after completing the 12-weeks double blind phase continued into an open-label extension (OLE) phase to evaluate the efficacy, long-term safety and tolerability of erenumab 70 mg monthly up to five years in 383 patients with episodic migraine. A protocol amendment increased the dose of erenumab to 140 mg monthly to assess long-term safety of the higher dose. In June 2018, Amgen released three-year interim analysis from this five-year study. In September 2019, company released long-term results from the study.In April 2020, long term interm analysis of more than four years was presented at the 72nd Annual Meeting of the American Academy of Neurology (AAN-2020) [54] [55] [20] [56] [57] [58] . In October 2020, Amgen announced five-year data of phase II trial [37] . In April 2021, Amgen presented the updated efficacy and safety results from the trial at the 73rd Annual Meeting of the American Academy of Neurology (AAN-2021) [59] .

In June 2019, Amgen completed a phase II trial that evaluated the safety and efficacy of multiple doses of erenumab for the prevention of episodic migraine (20120309; NCT02630459). The randomised, double blind, placebo control trial was initiated in January 2016, and enrolled 475 patients in Japan [60] . Patients were randomised to receive once-monthly subcutaneous placebo, or erenumab (28 mg, 70 mg or 140 mg) in a 2:1:2:2 ratio. In November 2018, Amgen Astellas Biopharma released positive data of the study [61] .

In April 2016, Amgen completed the randomised, double-blind phase II trial, which assessed the safety and efficacy of erenumab in chronic migraine prevention (20120295; NCT02066415; EudraCT2013-001707-36). The 12-week trial recruited 667 patients in the US, Canada, Czech Republic, Denmark, Germany, Finland, Norway, Poland and Sweden. In September 2017, positive results from a pre-planned sub-analysis of the trial were reported [62] [63] . In May 2017, an open-label extension study was completed that evaluated the long term safety and efficacy of the drug in preventing migraine (20130255; NCT02174861; EudraCT2013-005311-27). The one-year trial was initiated in June 2014, and enrolled 609 chronic migraine patients in the US, Canada, the Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden and the UK [64] [65] . In June 2018, Amgen released interim analysis of this one-year OLE study. Updated efficacy results from an exploratory analysis of the OLE were released in May 2019 [41] [56] . In June 2016, Amgen released positive top-line results of a phase II trial of a monthly subcutaneous injection of erenumab (7, 21 and 70mg), wherein the trial met its primary endpoint of reducing monthly mean migraine days as compared with placebo [66] . In May 2019, Amgen presented the efficacy data at the 71th Annual Meeting of the American Academy of Neurology (AAN-2019) [67] .

In February 2022, Amgen terminated a phase I as the regulatory and study team decided that the trial can move forward with the close out activities for the PK study since all ongoing patients have completed trial (NCT03499119; 20160172). The trial was completed in November 2021 that evaluated the safety, tolerability and pharmacokinetics of erenumab, in children and adolescents with migraine. The open label trial was initiated in May 2018 and enrolled 52 patients in the US [68] .

In September 2016, Amgen completed a phase I trial, which assessed the pharmacokinetic drug interaction of erenumab and an oral contraceptive containing progestin and estrogen in healthy female volunteers (20150334; NCT02792517). The open-label, single-group trial was initiated in February 2016 and recruited 35 volunteers in the US [69] .

Amgen completed a phase I trial, in August 2016, which investigated the effect on blood pressure of erenumab when given in combination with sumatriptan SC in healthy volunteers (NCT02741310; 20140255). The randomised, double-blind trial was initiated in February 2016 and enrolled 30 participants in Belgium. Results from the trial, which revealed that concomitant administration of IV erenumab 140mg with SC sumatriptan had no effect on resting blood pressure, as compared with SC sumatriptan alone, were presented at the 69th Annual Meeting of the American Academy of Neurology (AAN-2017) in April 2017 [70] [71] .

In November 2017, Amgen completed a phase I trial that evaluated the blockade of CGRP receptor by erenumab in preventing PACAP-38 (Pituitary Adenylate Cyclase-Activating Polypeptide-38) induced migraine-like attacks in migraine patients (20140207; NCT02542605). The randomised, double-blind, parallel-assignment, placebo-controlled trial was initiated in November 2015 and enrolled 38 volunteers in the US, Belgium and the Netherlands [72] .

Amgen initiated a randomised, double-blind, placebo-controlled phase I trial in November 2012, to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending subcutaneous doses of erenumab in healthy volunteers and patients with migraine (20101268; NCT01723514). The trial also investigated the effect of multiple doses of erenumab on capsaicin-induced increases in dermal blood flow. The trial enrolled 48 patients in Belgium, and was completed in July 2014 [73] .

Amgen terminated a randomised, double-blind, placebo-controlled phase I trial in November 2013 that was assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending intravenous and subcutaneous doses of erenumab in healthy volunteers and patients with migraine (20101267; NCT01688739; EudraCT2011-005600-15). The trial, which was initiated in March 2012, was also investigating the effect of single doses of erenumab on capsaicin-induced increases in dermal blood flow. The trial enrolled 60 patients in Belgium [74] .

In December 2019, Danish Headache Center in collaboration with Novartis and Amgen completed a phase II trial that evaluated the safety and efficacy of erenumab in the prophylactic treatment of persistent headache caused due to mild traumatic injury to the head (EudraCT2018-003943-46; NCT03974360). Change in the monthly average number of headache days with moderate or severe intensity from baseline to week 9-12 in patients with persistent post-traumatic headache (PPTH) was the primary endpoint. The exploratory open-label trial was initiated in April 2019 and enrolled 100 participants in Denmark [75] .

Trigeminal neuropathic pain

In December 2022, Amgen terminated a phase II trial due to low enrollment rate that was designed to evaluate the efficacy of erenumab-aooe in the management of trigeminal neuropathic pain comparing erenumab-aooe vs placebo (HP-00097072; NCT05142228). The single center, placebo-controlled, double blind, randomised study was initiated in April 2022 and enrolled 5 participants in the US [76] .

Temporomandibular joint dysfunction syndrome

In January 2023, Amgen terminated the phase II TMD CARE trial that intended to evaluate erenumab- aooe efficacy as a therapeutic approach, for the management of painful chronic temporomandibular disorders (TMD) due to low enrolment rate (HP-00093037; NCT05162027). The randomised, double blind, placebo-controlled study was initiated in April 2022 and enrolled 5 participants in the US [77] .

In January 2024, Indiana University, in collaboration with Novartis Pharmaceuticals completed a phase II trial which was designed to evaluate the safety and efficacy of the off-label use of subcutaneous administration of erenumab (Aimovig®) in reducing temporomandibular disorder (TMD) pain, compared with placebo (NCT04884763; 20-D-242; CAMG334AUS01T). The randomised, double-blind, placebo-controlled pilot study was initiated in November 2021 and enrolled 30 patients in the US [78] .

Menopausal syndrome

As at May 2018, the indication was not listed on the company pipelines, and the development for this indication appears to be discontinued.

In October 2014, Amgen completed a phase I trial of erenumab in women with menopausal hot flashes (20120180; NCT01890109). The trial was initiated in May 2013 and determined the effects of a single SC dose of erenumab on the frequency and severity of hot flashes. Tolerability, pharmacokinetics and the number of patients who develop anti-erenumab antibodies was also determined. Two dose levels of erenumab were evaluated. The randomised, double-blind trial enrolled 103 patients aged 45 to 65 years in the US [79] .

Cardiovascular safety trial

In April 2017, Amgen completed the phase II Treadmill cardiovascular safety trial that evaluated the effect of erenumab on exercise time during a treadmill test in patients with stable angina (NCT02575833; EudraCT2015-002322-40; 20140254). The randomised, double-blind, placebo-controlled trial was initiated in November 2015 and enrolled 89 patients in the US, Slovakia, Bulgaria, Germany, Latvia, Czech Republic, Poland, New Zealand, Romania, South Africa and Switzerland. In September 2017, positive results from the trial were reported [62] [80] .

Rosacea

In August 2021, Novartis completed the phase II STOP Ros trial, to assess the efficacy and tolerability of erenumab in the prophylactic treatment of persistent redness and flushing attributed to rosacea (ROS031019; EudraCT2019-003971-20; NCT04419259). The open label trial, initiated in June 2021, enrolled 30 patients in Denmark [81] .

Patent Information

As of February 2023, as per form 10-K, Amgen holds patent protection for erenumab covering 'Compositions and pharmaceutical formulations' in the US valid until 2039 [82] .

Amgen holds patent protection for CGRP receptor antibodies and methods of treatment in the US which are set to expire in 2032 and 2036 respectively. Similar patents issued in Europe are set to expire in 2029 and 2035 respectively [83] .

Novartis holds patents for erenumab in the US and EU. Patent in the US is set to expire in 2031, while patent in the EU will expire in 2029 [84] .

Drug Properties & Chemical Synopsis

  • Route of administration IV, SC
  • Formulation Injection, unspecified
  • Class Antimigraines, Monoclonal antibodies
  • Target Calcitonin gene-related peptide receptor
  • Mechanism of Action Calcitonin gene-related peptide receptor antagonists
  • WHO ATC code

    M09 (Other Drugs for Disorders of the Musculo-Skeletal System)

    N02C-D01 (Erenumab)

  • EPhMRA code

    M5X (All Other Musculoskeletal Products)

    N2C (Anti-Migraine Preparations)

  • Molecular formula C6472 H9964 N1728 O2018 S50
  • CAS Registry Number 1582205-90-0

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

migraine

Outcome Measure

thoracoabdominal syndrome

S100 calcium binding protein A12

microRNA 382

microRNA 34a

CALCA

1

2

1

1

2

migraine

Brief Title

S100 calcium binding protein A12

CALCA

1

2

migraine

Eligibility Criteria

Luteinizing hormone (LH)

Estradiol-17beta 3-sulfate

1

1

migraine

Official Title

S100 calcium binding protein A12

CREB3L1

CALCA

1

2

2

migraine

Brief Summary

microRNA 382

Interleukin-10 (IL-10)

1

1

migraine with aura

Brief Title

CALCA

1

migraine with aura

Official Title

CREB3L1

CALCA

1

1

migraine with aura

Outcome Measure

marginal zone B and B1 cell specific protein

CALCA

adenylate cyclase activating polypeptide 1

Adenosine monophosphate

1

1

1

1

migraine without aura

Brief Title

S100 calcium binding protein A12

CALCA

1

2

migraine without aura

Official Title

S100 calcium binding protein A12

CREB3L1

CALCA

1

1

2

migraine without aura

Outcome Measure

marginal zone B and B1 cell specific protein

Creatine

CALCA

adenylate cyclase activating polypeptide 1

Adenosine monophosphate

1

1

1

1

1

pain

Eligibility Criteria

Luteinizing hormone (LH)

1

Post-traumatic headache

Brief Title

S100 calcium binding protein A12

CALCA

1

1

Post-traumatic headache

Eligibility Criteria

Luteinizing hormone (LH)

1

rosacea

Eligibility Criteria

PSA

Luteinizing hormone (LH)

1

1

rosacea

Outcome Measure

PSA

1

traumatic brain injuries

Brief Title

S100 calcium binding protein A12

CALCA

1

1

trigeminal neuralgia

Eligibility Criteria

Luteinizing hormone (LH)

1

trigeminal neuralgia

Outcome Measure

PCNA clamp associated factor

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Erenumab - Amgen/Novartis Adenosine monophosphate Outcome Measure
adenylate cyclase activating polypeptide 1 Outcome Measure
CALCA Brief Title, Official Title, Outcome Measure
Creatine Outcome Measure
CREB3L1 Official Title
Estradiol-17beta 3-sulfate Eligibility Criteria
Interleukin-10 (IL-10) Brief Summary
Luteinizing hormone (LH) Eligibility Criteria
marginal zone B and B1 cell specific protein Outcome Measure
microRNA 34a Outcome Measure
microRNA 382 Brief Summary, Outcome Measure
PCNA clamp associated factor Outcome Measure
PSA Eligibility Criteria, Outcome Measure
S100 calcium binding protein A12 Brief Title, Official Title, Outcome Measure
thoracoabdominal syndrome Outcome Measure
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

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Headache Post-traumatic headache Prevention Phase II Denmark SC / Injection Amgen, Novartis 05 Apr 2019
Hot flashes - - Discontinued (I) USA SC / Injection Amgen 21 May 2018
Migraine - In adults, Prevention Marketed USA SC / Injection Amgen, Novartis 18 Jul 2018
Migraine - Prevention Marketed Canada, European Union, Iceland, Liechtenstein, Norway, Spain, Switzerland SC / Injection Novartis 13 Aug 2019
Migraine Erenumab 140 mg Sureclick® autoinjector device and Erenumab 140 mg prefilled syringe In adults, Prevention Registered Japan, USA SC / Injection Amgen 23 Jun 2021
Migraine - Prevention Registered Australia, Singapore, United Arab Emirates SC / Injection Novartis 29 Oct 2018
Migraine - In adolescents, In children, Prevention Phase III Belgium, Canada, Finland, Germany, Hungary, Italy, Japan, Poland, Switzerland, USA, United Kingdom SC / Injection Amgen 05 Sep 2019
Migraine - Prevention Phase III Russia, Turkey SC / Injection Amgen 20 Jul 2015
Migraine - Prevention Phase III Argentina, China, India, Lebanon, Malaysia, Mexico, Philippines, South Korea, Taiwan, Thailand, Vietnam SC / Injection Novartis 26 Aug 2019
Migraine - In adolescents, In children No development reported (I) USA unspecified / unspecified Amgen 28 Jun 2021
Migraine - - Discontinued (I) Belgium IV / unspecified Amgen 22 May 2018
Rosacea - - Phase II Denmark SC / Injection Novartis 09 Jun 2020
Temporomandibular joint dysfunction syndrome - In adults Phase II USA SC / Injection Indiana University, Novartis 02 Nov 2021
Trigeminal neuralgia - - Phase II Denmark SC / Injection Rigshospitalet 28 Oct 2019
Trigeminal neuralgia - - Phase II USA SC / Injection Amgen 11 Apr 2022

Commercial Information

Involved Organisations

Organisation Involvement Countries
Amgen Originator USA
Amgen Owner USA
Amgen Market Licensee Japan, USA
Novartis Market Licensee Canada, Europe, USA
Novartis Licensee World
Rigshospitalet Collaborator Denmark
Indiana University Collaborator USA
Amgen Astellas BioPharma Collaborator Japan

Brand Names

Brand Name Organisations Indications Countries
Aimovig Novartis, Amgen Migraine Canada, European Union, Japan, USA

Credit Suisse Market Status

Indication Region Company Phase Expected Launch Year Probability of Success% Patent Expiry Year Expected Generic Entry Last Update
Migraine ex US Amgen, Novartis Marketed 2018 100 2029 18 Dec 2030 05 Nov 2023
Migraine Japan Amgen, Novartis Filed 2021 99 - - 05 Nov 2023
Migraine US Amgen, Novartis Marketed 2018 100 2031 - 05 Nov 2023

Credit Suisse Financial Forecast

Indication Region 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Last Update
Migraine ex US 4 16 48 58 69 76 84 88 95 100 05 Nov 2023
Migraine Japan 60 167 192 211 228 237 249 250 250 250 05 Nov 2023
Migraine US 313 398 302 309 315 321 327 334 347 350 05 Nov 2023
Total 377 581 542 578 612 634 660 672 692 700

Scientific Summary

  • Adverse Events Frequent: Respiratory tract infections; Sinusitis
    Occasional: Abdominal pain; Arthralgia; Back pain; Constipation; Dental caries; Fatigue; Gastroenteritis; Influenza virus infections; Injection site pain; Nasopharyngitis; Pharyngitis

Adverse Events

Phase III

In a phase III DRAGON trial evaluating erenumab in patients with chronic migraine (CM) the safety and tolerability profile of erenumab 70 mg was overall similar to placebo, with the exception of constipation [49] [50] .

In the phase III STRIVE trial in 955 patients with episodic migraine, subcutaneous 70mg or 140mg of erenumab showed a safety profile, which was consistent with previously reported studies. The safety profile was also comparable to placebo across both the treatment arms. Nasopharyngitis, upper respiratory tract infection and sinusitis were observed as the most frequently reported adverse events [42] [43] .

Updated results in the open label extension phase (OLEP) of the trial (n=240) after 3-year completion, the commonly reported AEs (>10%) were nasopharyngitis, influenza, and back pain. Erenumab was well-tolerated, with no new safety signals reported after three years exposure. The trial discontinuation due to adverse events was reported in 4.6%patients (n=11) [38] . Earlier erenumab was found to be safe and effective in prevention of migraine, including those who live with particularly difficult-to-treat migraine. Results from the phase IIIb LIBERTY trial for erenumab conducted in 246 patients with episodic migraine showed that there were no adverse events leading to discontinuation of treatment in the treatment arm while 0.8% of those in the placebo group experienced adverse events leading to discontinuation of treatment. Injection site pain (5.9%), back pain (4.2%) and nasopharyngitis (4.2%) were the most common adverse events observed. The tolerability and safety profile of erenumab was found to be similar to that of placebo [9] [33] [36] .

The phase III ARISE study demonstrated a similar safety profile of erenumab compared with the placebo and consistent with previously reported studies. The most common adverse events reported were upper respiratory tract infection, injection site pain and nasopharyngitis. The trial enrolled 577 patients who experienced between four and 14 migraine days each month, with an average of eight migraine days per month at baseline and were randomised to receive either placebo or erenumab 70mg subcutaneously, once monthly [90] [47] [46] .

Phase II

The phase II Treadmill Cardiovascular safety trial, the most frequent treatment-emergent adverse events (reported in >2% of patients) were headache (4.5%) and viral upper respiratory infection (4.5%) in the erenumab group, and were hypotension (4.5%), influenza (4.5%) and viral infection (4.5%) in the placebo group. Adverse events were reported by 14% of erenumab -treated patients and by 27% of placebo patients and were consistent with the known safety profile of erenumab. The trial evaluated the effect of erenumab on exercise time during a treadmill test in 89 subjects with stable angina [62] [80] .

Updated resulted from the open-label treatment phase (OLTP) of the phase II trial of AMG 334 in patients for prevention of episodic migraine showed that safety was comparable with that observed in full population during randomised phase of the trial. Exposure-adjusted patient incidence of AEs and serious AEs during OLTP were 92.3 and 2.6 per 100 subject-years, respectively; This was lower than that observed for placebo during double-blind treatment period (DBTP). One fatality (“death unattended”) occurred during safety follow-up period whenAMG 334 was administered and was considered unrelated to AMG 334 by the investigator. Previously, results from the interim analysis of more than four years from a five-year open-label treatment period study demonstrated no new safety signals nor increases in adverse event (AE) or serious AE (SAE) incidence and was well tolerated and safe in patients (n = 383) with episodic migraine. Exposure-adjusted AE and SAE incidence rates were 124.9/100-patient-years and 3.8/100-patient-years. The most frequent AEs reported were nasopharyngitis (10.9/100-patient-years), upper respiratory tract infection (6.8/100-patient-years), and influenza (4.7/100-patient-years). Increase in constipation with long term treatment was not observed. Treatment was discontinued by 19 patients due to AE. Results of a three-year interim analysis from a five-year, open-label extension phase of the randomised, double-blind, placebo-controlled phase IIb 20120178 trial in 383 patients with episodic migraine demonstrated that erenumab had a safety profile consistent with the spectrum and rate of adverse events (AEs) seen in shorter-term placebo-controlled studies, no new AEs and no new causally-related serious AEs. The most frequent AEs were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, influenza and back pain. There was no increase in cardiovascular events over time and no meaningful changes in systolic/diastolic blood pressure or heart rate up to the ~3.2 year follow-up. Interim data of the open-label portion of erenumab 70mg monthly subcutaneous injection demonstrated safety and tolerability profile similar to that observed in the blinded phase. Arthralgia, influenza, fatigue, nasopharyngitis and back pain were the most commonly reported AEs and there were no grade 4 or 5 AEs. There was one treatment-related serious adverse event amongst others reported in 13 patients. Less than 5% of patients discontinued the trial due to adverse events. A monthly subcutaneous injection of erenumab (7, 21 and 70mg) demonstrated dose tolerability profile similar to placebo across all dosing groups, without any Grade 4 or 5 adverse events (AEs), in a 12-week phase II trial. Fatigue, influenza, nasopharyngitis, arthralgia and back pain were the most commonly reported AEs. The double-blind, randomised (3:2:2:2) trial assessed the efficacy and safety of erenumab for the prevention of episodic migraine in 483 patients [59] [54] [55] [56] [37] [53] [57] [58] .

In a phase II randomised, double bind trial, once in month subcutaneous erenumab showed safety profile similar to placebo in both treatment arms, 70mg and 140mg. Treatment with erenumab did not lead to any adverse event in greater than five percent of patients treated with erenumab. The most common adverse events (in placebo, 70 mg erenumab, 140 mg erenumab groups, respectively) were injection site pain (1.1%, 3.7%, 3.7%), upper respiratory tract infection (1.4% , 2.6%, 3.2%) and nausea (2.5%, 2.1%, 3.2%). The trial enrolled 667 patients of chronic migraine [65] [66] [63] .

Interim results of the open-label extension 20130255 study in 609 patients with chronic migraine showed that the safety results of erenumab after one year were consistent with the established safety profile in previous studies. The most frequent adverse events (AEs) greater than 2 per 100-subject-years were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, arthralgia and migraine [56] [64] .

Positive results of the randomised, six-month phase II trial in Japanese patients (n = 475) for the prevention of episodic migraine observed similar frequencies of adverse events and serious adverse events across erenumab and placebo groups. The most frequently reported adverse events (in at least 2% of patients in any group) were nasopharyngitis, constipation, pharyngitis, back pain, dental caries, gastroenteritis and upper abdominal pain [61] [60] .

Pooled analysis:

Data from pooled analysis of four placebo-controlled trials showed that erenumab had no significant effect on systolic and diastolic blood pressure over 12 weeks in patients with migraine as well as 24-hours continuously recorded blood pressure in healthy volunteers. Blood pressure remained stable over 12 weeks with no significant difference as compared with placebo treated patients. At week 12, mean (SD) change in systolic blood pressure (SBP) was -0.5 (10) and -1.0 (9.8) mmHg for erenumab; 70mg and 140mg, respectively compared with -0.4 (9.6) mmHg in placebo group. Mean (SD) change in diastolic blood pressure (DBP) was -0.3 (7.7) and -0.4 (7.2) mmHg compared with -0.6 (7.1) mmHg in placebo group. In a phase I trial, 24-hour continuously measured blood pressure was not changed in healthy volunteers receiving erenumab at 70 and 140mg, monthly over 12 weeks [88] [58] [63] [64] [43] [46] .

In both phase II 20120309 and phase III 20170609 trial, the safety and tolerability of erenumab was also consistent with previously available global data. The most commonly reported adverse reactions include constipation, injection site reactions and somnolence at an incidence of 1% or more [23]

Pooled results from the phase-III LIBERTY trial and phase II trial showed that, erenumab had a consistent favorable safety and tolerability profile with long-term exposure. The cumulative duration of exposure to erenumab during the DBTP and OLEP was 54.3 and 1899.5 patient-years, respectively and overall exposure-adjusted AE incidence rates were similar in the placebo and erenumab groups during the DBTP (357.5 vs 345.1/100 patient-years; no new AEs emerged over time during the OLEP (176.1/100 patient-years). The most common AE for the erenumab treatment groups (presented as n [r], whereby n = number of subjects reporting =1 AE) was nasopharyngitis (DBTP, 11 [20.9]; OLEP, 224 [24.0]). The incidence of constipation (DBTP: 4 [7.5]; OLEP: 40 [3.2]) and hypertension (DBTP: 3 [5.6]; OLEP: 46 [3.7]) remained low over time. The occurrence of anti-erenumab antibodies was 5.8% in the DBTP and 10.3% in the OLEP, with a respective 0.4% and 1.4% developing neutralizing antibodies [25] [58] [36] .

Immunogenicity

Summary

Pooled analysis:

Pooled analysis from four placebo-controlled phase II and phase III trial showed that treatment with erenumab was associated with low incidence of anti-erenumab antibodies with high reversal rate without any impact on the efficacy, pharmacokinetic and safety in patients. Incidence of anti-erenumab binding antibodies (BAbs) in serum was 6.3% (56/884) with 70mg. Three patients were found positive for neutralizing antibodies (NAbs) of which two patients were Nab-negative by end of studies. Incidence of BAbs was 2.6% (13/504) with 140mg without any NAb-positive patients. Half of the BAb-positive patients turned BAb-negative by end of study. Change in mean (SD) monthly migraine days compared with baseline at month three in BAb-negative patients was -3.2 (0.2) and -3.6 (0.2) at 70 and 140mg, respectively vs. -3.2 (0.7) and -4.1 (0.8) in BAb-positive patients. Change in mean (SD) monthly migraine days compared with baseline at month six in BAb-negative patients was -3.5 (0.2) and -3.8 (0.2) at 70 and 140mg, respectively vs. -3.2 (0.9) and -5.2 (0.9) in BAb-positive patients. Anti-erenumab binding antibodies (BAbs) had no effect on exposure wherein concentration in BAb-positive patients overlapped with BAb-negative patients at week 12. Anti-erenumab antibodies did not cause any safety issue and no injection-site reactions, hypersensitivity and immune-related disorders were reported [87] [58] [63] [64] [43] [46] .

Therapeutic Trials

Phase III

The phase III DRAGON trial evaluating erenumab in patients with chronic migraine (CM) met its primary endpoints, patients in the erenumab 70 mg group had a significantly greater reduction in monthly migraine days (MMD) from baseline compared to placebo. Moreover, patients in the erenumab 70 mg group had a significantly higher chance to achieve at least 50% reduction in MMD from baseline. Higher reductions in monthly acute headache medication days and mMIDAS scores were observed with erenumab 70 mg when compared to placebo [49] [50] .

The phase III STRIVE trial in 955 patients with episodic migraine met its primary endpoint, and statistically significant reduction from baseline in monthly migraine days was observed upon treatment with either 70mg or 140mg erenumab, when compared with placebo. At week 52, patients receiving erenumab 70mg (n=421) or 140mg (n=424) during active treatment phase (ATP) reported –4.2 / –4.6 monthly migraine days (MMD) changes from baseline and –1.1/–1.8 MMD from ATP baseline, respectively. For patients switching from placebo to erenumab change from ATP baseline was reported to be –2.2 and –2.9, respectively. Improvements were also reported in migraine specific medication treatment days. Further 61% of patients on 70mg and 64.9% of patients on 140mg demonstrated a ≥50% responder rates (RR) and 38.5% of patients on 70mg and 40.8% of patients on 140mg achieved a ≥75% RR, 19.8% of patients on 70mg and 21.2% of patients on 140mg achieved 100% RR. At baseline, patients experienced an average of 8.3 migraine days per month. Patients in the erenumab 70mg and 140mg treatment arms showed reductions of 3.2 and 3.7 days from baseline in monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm. Erenumab administration demonstrated reduction in migraine by 50% or greater in 50% patients at 140mg dose and 43% at 70mg dose, compared to 26.6% in placebo group. Odds ratio was noted to be 2.8 and 2.1 respectively for 140 and 70mg; P < 0.001 in both doses, versus placebo. Secondary point of reduction in the number of days of migraine episodes per month using acute migraine-specific medication was noted to be 1.6 days for 140mg, 1.1 days in 70mg dose, compared to 0.2 day placebo; both doses p < 0.001, versus placebo. Reduction in impact of migraine in day-to-day life activities (5.9 points for 140mg; 5.5 points for 70 mg; 3.3 points for placebo; p<0.001 for both doses, versus placebo) was noted as measured by MPFID instrument. Reduction in scores measuring physical impairment (4.8 points for 140 mg; 4.2 points for 70mg, 2.4 points for placebo; p<0.001 for both groups versus placebo) was also noted. Additional results from the trial demonstrated that 52% patients (n=492) out of 955, had history of aura with similar baseline characteristics among groups. In both subgroups, erenumab induced greater reductions in monthly migraine days (MMD) as compared with placebo. The least-squares mean (SE) changes from baseline were -1.5 (0.3) for placebo vs -2.7 (0.3) for 70-mg (p=0.002) and -3.8 (0.3) for 140mg (p<0.001) in patients without aura history, while in patients with aura history, changes were -2.1 (0.3) for placebo vs -3.8 (0.2) for 70mg (p<0.001) and -3.5 (0.3) for 140mg (p<0.001). The responder rates ( ≥ 50% reductions in MMDs) for patients without aura history were 23% (placebo) vs 39% (70mg odds ratio (95% CI): 2.1 (1.3, 3.5); p=0.003) and 49% (140mg OR: 3.3 (2.0, 5.4); p<0.001) and with aura history were 30% (placebo) vs 47% (70mg OR: 2.1 (1.3, 3.3); p=0.001) and 51% (140mg OR: 2.4 (1.5, 3.8); p<0.001). Changes in the respective migraine-specific medication days (MSMD) were -0.1 (0.2) vs -1.3 (0.2) and -2.0 (0.2) for patients without aura history (p<0.001 for both) and -0.3 (0.1) vs -1.0 (0.1) and -1.3 (0.1) for patients with aura history (p<0.001 for both). In an analysis of patients who had failed one or two previous oral preventive migraine medications, erenumab was shown to be superior to placebo in both subgroups. The odds of responding to erenumab increased in those who failed more than two prior preventive medications since the placebo response was attenuated. This indicated that erenumab is effective in those patients who have failed multiple previous preventive medications. The results from the trial showed that patients who received erenumab 70mg or 140mg from week 24 onward displayed an average of 4.2 and 4.6 fewer MMD, respectively, as compared with study baseline (8.3 MMD). Continuous improvements during the active-treatment period (ATP) were witnessed by the patients, with the respective dosages registering 1.1 and 1.8 fewer MMD. An analysis of responder rates from baseline showed that at 70mg or 140mg dosing, more than six of 10 patients displayed 50% fewer MMD, approximately four of 10 patients showed 75% fewer MMD, and one of five patients were completely relieved of migraine, at week 52. The updated results showed that at 52 weeks, 55 % of the patients on 140 mg of erenumab experienced at least 50 % reduction in the number of MMD requiring acute medication. The drug exhibited sustained efficacy in patients with episodic migraine, who failed prior preventions throughout the 52 week period [39] [40] [41] [95] [44] [45] [42] [43] .

Updated results in the open label extension phase (OLEP) of the LIBERTY trial (n=240), the ≥30%, ≥50%, ≥75%, and 100% responder rates at 3-year completion were 72.8%, 52.3%, 33.1%, and 13.2%, respectively. The mean (SD) change in MMD from baseline at 3-year completion was −4.4 (3.9). Mean (SD) change in HIT-6, MPFID-EA, and MPFID-PI scores from baseline at 3-year completion was –9.7 (8.9), –6.1 (8.2) and –5.1 (7.6), respectively. The efficacy was sustained over 3 years in patients with EM and 2–4 prior non successful migraine preventive therapies. [38] . Earlier the trial displayed sustained efficacy for erenumab 140mg in lowering monthly MMD at 13-24 weeks in episodic migraine patients with 2-4 prior failures. A sustained reduction in physical impairment and an improved ability to participate in daily activities was exhibited by patients on erenumab, at week 24. Earlier in the trial, at week 24, 39.2%, 15.9% and 7.0% patients achieved ≥50%/≥75%/100% reduction in monthly migraine days. The mean change from baseline in monthly migraine days was −2.7 (4.4) and −1.4 (3.0) in MSMD; and −7.6 (8.0), −2.5 (9.2) and −4.0 (9.0) in HIT-6 ™, MPFID-PI and MPFID-EA scores respectively. With sustained use patients experienced sustained efficacy in all outcomes assessed. Patients who switched from placebo to erenumab in the open-label extension phase demonstrated an improvement from the first measurement at week 16 on all outcomes assessed [31] . Patients receiving once monthly subcutaneous injection of erenumab 140mg had nearly three-fold higher odds of having their migraine days cut by at least 50%, with more than twice as many patients taking erenumab achieving this reduction compared to placebo (weeks 9-12: 30% with erenumab, 14% with placebo, p=0.002, odds ratio 2.7). In the study, patients receiving erenumab had statistically significant and clinically meaningful improvements from baseline compared to placebo across all secondary endpoints: reduction in monthly migraine days; decrease in monthly acute migraine-specific drug use; 75% or greater reduction in monthly migraine days (12% vs. 4%; odds ratio 3.2, p=0.025); migraine days were cut by 100% in 6% of patients on erenumab vs no patients (0%) on placebo (secondary endpoint); a substantial reduction in monthly migraine days (MMD) (1.8 vs 0.2 fewer MMD, p=0.004, secondary endpoint) was observed; significant reductions in the number of days per month were reported in erenumab arm using acute migraine-specific medication (1.3 reduction vs 0.5 day increase; p<0.001, secondary endpoint); improved physical functioning and ability to complete everyday activities, such as chores and getting out of bed, compared to placebo (Migraine Physical Function Impact Diary [MPFID] physical impairment scale, 3.5 point difference, p= 0 003; everyday activities scale, 3.9 point difference, p<0 001) [32] [9] [89] [33] [34] [35] [36] .

Topline results from the phase III ARISE trial demonstrated that the primary endpoint in the trial was met with a statistically significant 2.9-day reduction from baseline in monthly migraine days in patients in the erenumab arm compared with a 1.8-day reduction in the patients in placebo arm. The trial enrolled 577 patients who experienced between four and 14 migraine days each month, with an average of eight migraine days per month at baseline and were randomised to receive either placebo or erenumab 70mg subcutaneously, once monthly [90] [47] [46] .

Results from the phase III EMPOWER trial demonstrated that at month 3, greater improvement from baseline in HIT-6 score was observed in erenumab groups compared to placebo (erenumab 140mg -9.34,p=0.001, 70mg -8.39,p=0.004, and placebo -6.62). Erenumab groups showed greater improvements from baseline at month 3 in MPFID scores versus placebo (MPFID-physical impairment scores, erenumab 140mg -4.27,p=0.014, 70mg -3.95,p=0.021, and placebo-2.31; MPFID-everyday activities scores, erenumab 140mg -5.61,p=0.002, 70mg -4.94,p=0.011, and placebo-3.19). Greater reductions from baseline at month 3 in mMIDAS scores were observed in erenumab groups versus placebo (erenumab 140mg -8.99,p=0.001, 70mg -8.11,p=0.011, and placebo -6.59). Change in EQ-5D-5L quality-of-life visual analog scale from baseline at month 3 was greater in erenumab groups compared to placebo (erenumab 140mg 8.13,p=0.017, 70mg 7.08,p=0.088, and placebo 5.22) [30] [29]

Phase II:

Updated resulted from the open-label treatment phase (OLTP) of the phase II trial of AMG 334 in patients for prevention of episodic migraine showed that five years of treatment demonstrated consistent and sustained response. Mean (SD) change in monthly migraine days (MMD) from DBTP baseline of 8.5(2.5) days was –4.8(3.9) at week 64 (mean of last 4 weeks of 1-year OLTP; N=129), and –5.3(3.9) at week 268 (mean of last 4 weeks of 5-year OLTP). Patients achieving MMD response at week 64/268 was 62%/69% for achievement of =50% reduction; 41%/48% for =75% reduction; and 26%/36% for 100% reduction. In acute migraine-specific medication (AMSM) users at baseline (6.1[2.7] treatment days/month), mean(SD) change in AMSM days was –3.2(3.5) at week 64 and –4.4(3.3) at week 268. Clinically meaningful improvements were observed in HIT-6TM: 68%/72% of patients achieved =5-point reduction from baseline at weeks 64/268. Previous results from the five-year open-label treatment period study demonstrated sustained efficacy in patients with episodic migraine. 4.5 year data reported that 77% of the patients who continued on treatment experienced at least a 50% reduction in monthly migraine days (MMD) at the last month of assessment and 33% of patients who continued on treatment achieved a 100% reduction, and 56% achieved a 75% decrease in MMD. Patients who shifted from 70mg to 140mg specifically, had an average of 5.8 fewer MMD, as compared with study baseline (8.7 MMD). A monthly subcutaneous injection of erenumab (7, 21 and 70mg) met its primary endpoint by reducing monthly mean migraine days (mean baseline = 8.7 days), measured at week 12, in a phase II trial. Statistically significant reductions in monthly migraine days (3.4 vs 2.28; p = 0.021), in monthly headache days (-3.54 vs -2.39) and monthly migraine-specific medication use days (-1.64 vs. -0.69) was observed in patients randomised to 70mg dose group as compared with placebo. Additionally, statistically significant increase in the 50% responder rate was shown by the drug (47% vs 30% placebo; secondary endpoint). The double-blind, randomised (3:2:2:2) trial assessed the efficacy and safety of erenumab for the prevention of episodic migraine in 483 patients [59] [55] [53] [58] .

A phase II double-blind study met its primary endpoint of reduction in monthly migraine days upon once in a month subcutaneous administration of 70mg or 140mg of erenumab in patients with chronic migraine. Erenumab demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine. At week 12, a reduction of 50 percent or more in number of monthly migraine days was observed in 40 percent and 41 percent of individuals receiving 70 mg and 140 mg doses erenumab, respectively, compared with 24 percent of those receiving placebo (both p < 0.001). Across both doses, patients observed a statistically significant 6.6-day reduction from baseline in monthly migraine days compared with 4.2 days observed in those on placebo (p < 0.001). Reductions in monthly acute migraine-specific medication days were 3.5 days and 4.1 days in the 70 mg and 140 mg groups, respectively, compared to a 1.6-day reduction the placebo group (both doses p < 0.001 versus baseline). Compared to a 55.2-hour reduction versus baseline in the placebo group, reductions were 64.8 hours (p = 0.28) for 70 mg erenumab and 74.5 hours (p = 0.03) for 140 mg erenumab. Days requiring acute pain-relief medications were also significantly reduced in both dosage arms (2.1-day reduction for placebo, compared to 5.4 days for erenumab 70 mg and 4.9 for erenumab 140 mg; both p < 0.001 versus placebo). Both doses of erenumab were associated with significant improvements in health-related quality of life, headache impact, disability, and pain interference outcome measurements, compared to placebo. In a pre-specified sub-analysis, at the end of the 12-week study, patients who had failed two or more prior treatments experienced a reduction of 7.0 days and 5.4 days in the erenumab 140mg and 70mg, respectively, compared to placebo reduction of 2.7 days (p<0.001). In the erenumab treated arms, the odds of cutting migraine days in at least half was three-to-four fold higher than in the placebo arm (140mg: 41.3% , 70mg: 35.6%, placebo: 14.2% (p<0.001 for both doses versus placebo). The trial enrolled 667 patients (mean age 42.1, 79.0 percent female) who were randomised to receive either subcutaneous placebo (n=286) or subcutaneous erenumab 70 mg (n=191) or 140 mg (n=190) once a month [62] [94] [93] [91] [65] [66] [63] .

Interim data from a five-year open-label extension phase of the randomised, double-blind, placebo-controlled phase IIb 20120178 trial in 383 patients with episodic migraine demonstrated that more than one in four (26%) patients who were assessed over fifteen months, were completely migraine free. Sustained reduction with an average of 5.3 day from a baseline of 8.7 mean monthly migraine days was observed at week 52 with administration of erenumab 70mg monthly subcutaneous injection, regardless of treatment received during the blinded phase. At 52 weeks, there was 62% of 50% responder rate 38% of 75% responder rate and 19% of 100% responder rate. By the end of the study, patients who used (acute migraine-specific medication) AMSM to treat their migraine headaches experienced an average reduction in AMSM use of 4.4 days from the placebo controlled treatment period baseline of 6.2 days [37] [20] [57] [58] .

Updated results from open-label extension phase II trial, showed that after the long term treatment of erenumab conversion of chronic migraine to episodic migraine was observed. The conversion was 64% at week 12, 68% at week 24, 69% at week 40 and 72% at week 52. By end of the last dose, 69% and 76% were converted at week 52. Monthly migraine days for converters against non-converters was −10.6/−3.8 (70mg) and −12.5/−4.2 (140mg). Around greater than 50% patients showed the response for converters as 105/148 (70mg) and 103/125 (140mg) at week 52 and 50% and greater for non-converters response was 9/66 (70mg) and 8/40 (140mg) at week 52 [67] . Interim results of the open-label extension (OLE) 20130255 study in 609 patients with chronic migraine demonstrated sustained benefits up to one year with erenumab treatment. Patients taking erenumab 140 mg and 70 mg (based on last dose received) achieved reductions of average monthly migraine days of 10.5 and 8.5 days, respectively, when compared with a baseline of 18.1 days. Patients treated with erenumab experienced reductions in monthly migraine days of 50% or more (67% patients on 140 mg and 53% patients on 70 mg), 75% or more (42% on 140 mg and 27% on 70 mg) and 100% reduction (13% on 140 mg and 6% on 70 mg). Updated results from an exploratory analysis of the OLE showed that at 52 weeks, more than two-thirds of patients with chronic migraine converted to episodic migraine by the time they received the last dose of erenumab. The monthly migraine days (MMD) reduced from 17 at baseline, to 11 at week 52, for these patients. Both doses explored in the OLE displayed high conversion rates, with the 140mg dose of erenumab being numerically higher (76%), as compared with the 70mg dose (69%) [41] [56] [64] .

Phase I:

In a phase I trial involving 34 healthy adults, baseline mean (SD) systolic BP (SBP), diastolic BP (DBP), and MAP, respectively, were 122.8 (6.5), 70.1 (5.6), and 87.5 (5.0) mmHg. Differences in SBP, DBP, or MAP were not observed between subjects who received sumatriptan alone and those who received concomitant sumatriptan and erenumab (upper limit of the 90% CI for the treatment difference was <5 mmHg). A post-hoc analysis revealed no increase in MAP within the same subjects following erenumab alone (mean [SD] change from pre-dose: -0.3 [5.2]) or placebo (-0.5 [5.7]); but a mean change of 0.7 (4.8) was observed, following administration of sumatriptan alone [70] [71] .

Positive results of the randomised, placebo-controlled, six-month phase II trial in Japanese patients (n = 475) for the prevention of episodic migraine demonstrated that erenumab showed statistically significant differences for all primary and secondary endpoints, when compared with placebo. Patients taking erenumab at the dose of 70 mg and 140 mg observed a significant reduction in mean monthly migraine days (MMD) (differences from placebo in reduction of mean MMD are 2.3 and 1.9 day, individually, p < 0.001). Patients taking erenumab 70 mg and 140 mg doses were significantly achieved a 50% or greater reduction in MMD, than the patients treated with placebo. Acute migraine-specific medication treatment days were also significantly reduced in the patients taking erenumab. Erenumab treated patients reported significant improvements in HIT-6TM, a patient-reported outcome assessing the impact of migraine on their lives, when compared with placebo [61] [60] .

Phase II

The phase II Treadmill Cardiovascular safety trial met it primary endpoint of noninferiority, showing no difference in exercise time among participants receiving erenumab or placebo. As compared with placebo, the change from baseline in total exercise time was non-inferior in the erenumab group, while no differences were observed in the time to onset of 1mm ST-segment depression, time to onset of exercise-induced angina. The treatment difference in mean change from baseline in exercise time was -11.0 seconds (90 percent confidence interval -44.9, 22.9). In addition, no significant differences were seen between the two groups in time to onset of angina or time to onset of electrocardiogram change consistent with onset of myocardial ischaemia. The trial evaluated the effect of erenumab on exercise time during a treadmill test in 89 subjects with stable angina [95] [62] [80] .

In both phase II 20120309 and phase III 20170609 trial, erenumab significantly reduced monthly migraine days (MMD) from baseline over months 4, 5 and 6 of the double-blind treatment period (DBTP) [23] .

Results of a subgroup analysis from phase III STRIVE trial in women of childbearing potential with/without a self-reported history of MRM demonstrated a similar mean baseline MMDs. The least squares means (LSM, SE) of change in MMD for 70mg and 140mg vs placebo (p<0.001 for all) were ‒ 3.3 (0.4)/ ‒ 3.4 (0.3) and ‒ 3.6 (0.4)/ ‒ 3.6 (0.2) vs ‒ 1.5 (0.4)/ ‒ 1.9 (0.3). The change in the LSM (SE) in MSMD was‒ 1.1 (0.2)/ ‒ 1.1 (0.2) and ‒ 1.6 (0.2)/ ‒ 1.5 (0.2) vs ‒ 0.1 (0.2)/ ‒ 0.2 (0.2) for 70mg and 140mg vs placebo (p=0.002/<0.001 for 70mg, p<0.001/<0.001 for 140mg). For 70mg, a ≥ 50% reduction in MMD was achieved, 45%/42% (OR: 2.3/2.0; p=0.016/0.005), 50%/47% (OR: 2.7/2.6; p=0.002/<0.001) for 140mg, and 27%/27% for placebo. Eerenumab equally reduced MMD, MSMD and improved 50% responder rate in women with and without a history of menstrually-related migraine (MRM) [43] [86] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2027 Regulatory Status Novartis plans to file a regulatory application in Migraine in or after 2027 (Novartis pipeline, February 2022) [85] 06 Feb 2024
09 Sep 2019 Trial Update Amgen plans the phase III OASIS (CM) trial for Migraine (In adolescents, In children) in Belgium, Finland, Germany, Hungary, Poland, the United Kingdom and the USA in Septmeber 2019(EudraCT2017-002399-23) (NCT03832998) (700304411) 14 Jul 2020
02 Sep 2019 Trial Update Novartis plans the phase III DRAGON trial in Migraine in September 2019 (NCT03867201) (700305295) 11 Sep 2019
06 Jun 2019 Trial Update Amgen plans the phase III OASIS (EM) trial for Migraine (Prevention, In adolescents, In children) in Belgium, Canada, Colombia, England, Finland, Germany, Hungary, Poland, Russia, Scotland, Switzerland, United Kingdom, USA (SC) (EudraCT2017-002397-39) (NCT03836040) 31 Jul 2019
18 Apr 2019 Trial Update Amgen plans a phase III trial for Migraine (Prevention, In adults, In the elderly) in Japan in April 2019 (NCT03812224) (700303809) 10 Jul 2019
31 May 2018 Regulatory Status Amgen intends to launch erenumab for Migraine in May 2018 [11] 01 Aug 2018
17 May 2018 Regulatory Status FDA assigns PDUFA action date of 17/05/2018 for erenumab for Migraine (Prevention) [13] 21 May 2018
05 Feb 2018 Trial Update Novartis Pharmaceuticals plans the phase III EMPOwER trial in Migraine (Prevention) (SC) (CAMG334A2302; NCT03333109) (700290118) 01 Mar 2018

Development History

Event Date Update Type Comment
19 Jan 2024 Trial Update Indiana University in collaboration with Novartis Pharmaceuticals completes a phase II trial in Temporomandibular joint dysfunction syndrome (In adults) in USA (SC) (NCT04884763) Updated 06 Feb 2024
05 Nov 2023 Financial Update Credit Suisse financial data update Updated 05 Nov 2023
28 Feb 2023 Patent Information Amgen has patent protection for erenumab in USA [82] Updated 28 Feb 2023
03 Jan 2023 Trial Update Amgen terminates the phase II TMD CARE trial for Temporomandibular joint dysfunction syndrome in USA (SC) due to low enrolment rate (NCT05162027) Updated 24 Jan 2023
27 Oct 2022 Trial Update Amgen terminates phase-II trials in Trigeminal neuralgia in USA (SC) due to low enrollment rate (NCT05142228) Updated 21 Dec 2022
06 Jun 2022 Scientific Update Efficacy and adverse events data from a phase III DRAGON trial in Migraine presented at the 74th Annual Meeting of the American Academy of Neurology 2022 (AAN-2022) [49] Updated 06 Jun 2022
11 Apr 2022 Phase Change - II Phase-II clinical trials in Trigeminal neuralgia in USA (SC) (NCT05142228) Updated 20 Apr 2022
11 Apr 2022 Trial Update Amgen initiates enrolment in the phase II TMD CARE trial for Temporomandibular joint dysfunction syndrome in USA (SC) (NCT05162027) Updated 20 Apr 2022
08 Apr 2022 Scientific Update Updated safety and efficacy data from a phase III LIBERTY trial in Migraine presented at the 74th Annual Meeting of the American Academy of Neurology 2022 (AAN-2022) [38] Updated 07 Jun 2022
02 Apr 2022 Scientific Update Efficacy data from the phase III EMPOWER trial in Migraine presented at the 74th Annual Meeting of the American Academy of Neurology 2022 (AAN-2022) [30] Updated 06 Jun 2022
02 Apr 2022 Scientific Update Pooled adverse events data from a phase II and III trial in Migraine presented at the 74th Annual Meeting of the American Academy of Neurology 2022 (AAN-2022) [25] Updated 06 Jun 2022
23 Feb 2022 Trial Update Amgen terminates a phase I trial in Migraine in USA because as per Amgen Regulatory and Study Team, the trial can move forward with the close out activities for the PK study since all ongoing patients have completed trial (NCT03499119) Updated 02 Mar 2022
16 Feb 2022 Patent Information Amgen has patent protection for erenumab CGRP receptor antibodies and methods of treatment in USA and the Europe [83] Updated 02 Mar 2022
02 Dec 2021 Biomarker Update Biomarkers information updated Updated 04 Dec 2021
02 Nov 2021 Phase Change - II Phase-II clinical trials in Temporomandibular joint dysfunction syndrome (In adults) in USA (SC) (NCT04884763) Updated 19 Nov 2021
31 Oct 2021 Trial Update Dansk Hovedpine Center completes its phase II clinical trials in Trigeminal neuralgia in Denmark (unspecified route) (NCT04054024) Updated 03 Nov 2021
31 Aug 2021 Trial Update Novartis completes the phase II STOP Ros trial in Rosasea in Denmark (NCT04419259) (EudraCT2019-003971-20) Updated 28 Dec 2021
28 Jun 2021 Phase Change - No development reported No recent reports of development identified for phase-I development in Migraine(In adolescents, In children) in USA Updated 28 Jun 2021
23 Jun 2021 Phase Change - Registered Registered for Migraine (Prevention, In adults) in Japan (SC) [23] Updated 24 Jun 2021
23 Jun 2021 Scientific Update Pooled efficacy and safety data from phase II and phase III in Migraine released by Amgen [23] Updated 24 Jun 2021
17 Apr 2021 Scientific Update Updated efficacy and adverse events data from open-label extension study of phase II trial in migraine presented at the 73rd Annual Meeting of the American Academy of Neurology (AAN-2021) [59] Updated 23 Jun 2021
28 Jan 2021 Trial Update Novartis Pharmaceuticals completes a phase III LIBERTY trial in Episodic Migraine in Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom (NCT03096834) Updated 07 Jul 2022
25 Nov 2020 Trial Update Amgen completes the phase III trial in Migraine (Prevention, In adults, In the elderly) in Japan (SC) (NCT03812224) Updated 09 Dec 2020
03 Oct 2020 Scientific Update Efficacy and safety data from a phase II trial in migraine released by Amgen [37] Updated 06 Oct 2020
01 Sep 2020 Phase Change - Preregistration Preregistration for Migraine (Prevention) in Japan (SC) [24] Updated 30 Oct 2020
22 Jul 2020 Regulatory Status Novartis plans to file a regulatory application in Migraine in or after 2027 (Novartis pipeline, February 2022) [85] Updated 06 Feb 2024
09 Jun 2020 Phase Change - II Phase-II clinical trials in Rosacea in Denmark (SC) (NCT04419259) Updated 25 Jun 2020
25 Apr 2020 Scientific Update Long-term safety data from a phase II trial in Migraine presented at the 72nd Annual Meeting of the American Academy of Neurology (AAN-2020) [54] Updated 22 May 2020
04 Feb 2020 Regulatory Status An independent appeal panel pronounces that NICE needs to request evidence for establishing erenumab effectiveness in a subgroup of patients with Migraine [6] Updated 10 Feb 2020
13 Jan 2020 Trial Update Novartis completes the phase III EMPOwER trial in Migraine (Prevention) in Argentina, India, Mexico, Philippines, Vietnam, South Korea, Lebanon, Malaysia, Singapore, Taiwan and Thailand (SC) (NCT03333109) Updated 16 Apr 2020
31 Dec 2019 Trial Update Danish Headache Center in collaboration with Novartis and Amgen completes a phase II trial in Headache (Prevention) in Denmark (SC, Injection) (NCT03974360) Updated 19 Feb 2020
28 Oct 2019 Phase Change - II Phase-II clinical trials in Trigeminal neuralgia in Denmark (unspecified route) (NCT04054024) Updated 29 Nov 2019
09 Sep 2019 Scientific Update Long-term efficacy and safety data from a phase II trial in Migraine released by Novartis [55] Updated 10 Sep 2019
05 Sep 2019 Phase Change - III Phase-III clinical trials in Migraine (In adolescents, In children, Prevention) in Poland, Germany, Canada, Italy, Japan (SC) (EudraCT2017-002399-23) (NCT03832998) Updated 14 Jul 2020
05 Sep 2019 Trial Update Amgen initiates enrolment in the phase III OASIS trial for Migraine (In adolescents, In children, Prevention) in USA, Belgium, Finland, Hungary, United Kingdom (SC) (EudraCT2017-002399-23) (NCT03832998) Updated 14 Jul 2020
26 Aug 2019 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in China(NCT03867201) Updated 17 Aug 2021
16 Aug 2019 Trial Update Amgen plans the phase III OASIS (CM) trial for Migraine (In adolescents, In children) in Belgium, Finland, Germany, Hungary, Poland, the United Kingdom and the USA in Septmeber 2019(EudraCT2017-002399-23) (NCT03832998) Updated 14 Jul 2020
13 Aug 2019 Phase Change - Marketed Launched for Migraine (Prevention) in Spain (SC) Updated 10 Sep 2019
19 Jul 2019 Trial Update Amgen initiates enrolment in the phase III OASIS trial for Migraine (In adolescents, In children, Prevention) in Germany, Poland, Canada, Italy, Japan (SC) (EudraCT2017-002399-23) (NCT03832998) Updated 14 Jul 2020
19 Jul 2019 Phase Change - III Phase-III clinical trials in Migraine (In adolescents, In children, Prevention) in Finland, Belgium, USA, Hungary, Switzerland, United Kingdom (SC) (NCT03836040) (EudraCT2017-002397-39) Updated 31 Jul 2019
02 Jul 2019 Scientific Update Updated efficacy data from the phase III STRIVE trial in Migraine released by Novartis [40] Updated 03 Jul 2019
01 Jul 2019 Scientific Update Updated efficacy data from the phase IIIb LIBERTY trial in Migraine released by Novartis [32] Updated 05 Jul 2019
05 Jun 2019 Trial Update Amgen completes a phase II trial in Migraine (Prevention) in Japan (SC) (NCT02630459) Updated 10 Jul 2019
04 May 2019 Scientific Update Efficacy data from a open-extension study for phase II trial in Migraine presented at the 71th Annual Meeting of the American Academy of Neurology (AAN-2019) [67] Updated 21 Nov 2019
04 May 2019 Scientific Update Updated efficacy data from the phase III STRIVE trial in Migraine presented at the 71st Annual Meeting of the American Academy of Neurology (AAN-2019) [39] Updated 20 Nov 2019
04 May 2019 Scientific Update Efficacy data from the phase IIIb LIBERTY trial in Migraine presented at the 71st Annual Meeting of the American Academy of Neurology [31] Updated 01 Nov 2019
02 May 2019 Scientific Update Updated efficacy data from the phase III STRIVE trial and a one-year open label extension (OLE) trial in Migraine released by Amgen [41] Updated 07 May 2019
12 Apr 2019 Phase Change - III Phase-III clinical trials in Migraine (Prevention, In adults, In the elderly) in Japan (SC) (NCT03812224) Updated 02 May 2019
05 Apr 2019 Phase Change - II Phase-II clinical trials in Headache (Prevention) in Denmark (SC) (NCT03974360) Updated 12 Jun 2019
04 Apr 2019 Licensing Status Novartis files lawsuit against Amgen concerning the latter's Notice of termination of collaboration agreement [3] Updated 10 Apr 2019
31 Mar 2019 Phase Change - Registered Registered for Migraine (Prevention, In adults) in USA (SC) [4] Updated 06 May 2019
13 Mar 2019 Trial Update Novartis plans the phase III DRAGON trial in Migraine in September 2019 (NCT03867201) Updated 11 Sep 2019
23 Feb 2019 Trial Update Amgen plans the phase III OASIS (EM) trial for Migraine (Prevention, In adolescents, In children) in Belgium, Canada, Colombia, England, Finland, Germany, Hungary, Poland, Russia, Scotland, Switzerland, United Kingdom, USA (SC) (EudraCT2017-002397-39) (NCT03836040) Updated 31 Jul 2019
23 Jan 2019 Trial Update Amgen plans a phase III trial for Migraine (Prevention, In adults, In the elderly) in Japan in April 2019 (NCT03812224) Updated 10 Jul 2019
10 Jan 2019 Regulatory Status The National Institute for Health and Care Excellence (NICE) does not recommend erenumab for routine use on the National Health Services (NHS) for Migraine (Prevention, In adults) [8] Updated 16 Jan 2019
03 Dec 2018 Phase Change - Marketed Launched for Migraine (Prevention) in Canada (SC) [17] Updated 05 Dec 2018
19 Nov 2018 Scientific Update Interim efficacy and adverse events data from a phase II trial in migraine released by Amgen Astellas Biopharma [61] Updated 27 Nov 2018
29 Oct 2018 Phase Change - Registered Registered for Migraine (Prevention) in United Arab Emirates (SC), Singapore (SC) [9] Updated 29 Oct 2018
23 Oct 2018 Scientific Update Efficacy and adverse events data from the phase IIIb LIBERTY trial in Migraine released by Novartis [9] Updated 29 Oct 2018
30 Sep 2018 Phase Change - Marketed Launched for Migraine (Prevention) in Switzerland, Iceland, Liechtenstein, Norway, Norway, European Union (SC) [19] Updated 24 Oct 2018
07 Sep 2018 Trial Update Novartis completes enrolment in its phase III LIBERTY trial for Migraine (Prevention) in Australia, Austria, Belgium, Czech, Denmark, Finland, France, Germany, Greece, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland and in the UK (NCT03096834) (EudraCT2016-002211-18) Updated 11 Jan 2021
03 Aug 2018 Phase Change - Registered Registered for Migraine (Prevention) in Canada (SC) [18] Updated 07 Aug 2018
30 Jul 2018 Scientific Update Updated efficacy data from a phase IIb trial in Episodic migraine released by Novartis [20] Updated 03 Aug 2018
30 Jul 2018 Phase Change - Registered Registered for Migraine (Prevention) in European Union, Iceland, Liechtenstein, Norway (SC) [20] Updated 01 Aug 2018
26 Jul 2018 Phase Change - Preregistration Preregistration for Migraine (Prevention, In adults) in USA (SC, Injection, 140 mg) [5] Updated 17 Aug 2018
18 Jul 2018 Phase Change - Marketed Launched for Migraine (Prevention, In adults) in USA (SC) [12] Updated 20 Jul 2018
13 Jul 2018 Phase Change - Registered Registered for Migraine (Prevention) in Switzerland (SC) [20] Updated 01 Aug 2018
03 Jul 2018 Phase Change - Registered Registered for Migraine (Prevention) in Australia (SC) [20] Updated 01 Aug 2018
28 Jun 2018 Scientific Update Interim three-year adverse events data from open-label extension of the phase IIb trial in Migraine released by Amgen [56] Updated 06 Jul 2018
28 Jun 2018 Scientific Update Interim efficacy and adverse events data from open-label extension of the phase II trial in Migraine released by Amgen [56] Updated 06 Jul 2018
01 Jun 2018 Regulatory Status The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of erenumab for Migraine (Prevention) in European Union [22] Updated 04 Jun 2018
22 May 2018 Phase Change - Discontinued(I) Discontinued - Phase-I for Migraine in Belgium (IV) Updated 22 May 2018
21 May 2018 Phase Change - Discontinued(I) Discontinued - Phase-I for Hot flashes in USA (SC) Updated 21 May 2018
17 May 2018 Regulatory Status Amgen intends to launch erenumab for Migraine in May 2018 [11] Updated 01 Aug 2018
17 May 2018 Phase Change - Registered Registered for Migraine (Prevention, In adults) in USA (SC) - First global approval [10] Updated 21 May 2018
04 May 2018 Phase Change - I Phase-I clinical trials in Migraine (In adolescents, In children) in USA (unspecified route) (NCT03499119) Updated 13 Jun 2018
21 Apr 2018 Scientific Update Efficacy data from a phase III STRIVE trial in Migraine with aura and Menstrually-related migraine presented at the 70th Annual Meeting of the American Academy of Neurology (AAN-2018) [44] [86] Updated 10 May 2018
21 Apr 2018 Scientific Update Immunogenicity and safety data from pooled analysis of clinical trials in Migraine presented at the 70th Annual Meeting of the American Academy of Neurology (AAN-2018) [87] [88] Updated 10 May 2018
18 Apr 2018 Trial Update Amgen plans a phase I trial for Migraine (In Children and Adolescents) in USA (NCT03499119) Updated 19 Apr 2018
17 Apr 2018 Scientific Update Adverse events data from the phase III LIBERTY trial in Migraine released by Amgen [33] Updated 20 Apr 2018
17 Apr 2018 Scientific Update Updated efficacy data from the phase III LIBERTY trial in Migraine released by Amgen [89] Updated 20 Apr 2018
08 Feb 2018 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Vietnam, Philippines, Mexico, India (SC) (NCT03333109) Updated 16 Apr 2020
08 Feb 2018 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Thailand, Taiwan, Singapore, Malaysia, South Korea, Argentina (SC) (NCT03333109) Updated 21 May 2018
08 Feb 2018 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Lebanon (SC) (NCT03333109) Updated 01 Mar 2018
24 Jan 2018 Patent Information Novartis has patent protection for Erenumab in USA and the European Union [84] Updated 20 Apr 2018
22 Jan 2018 Scientific Update Efficacy data from a phase III trial in Migraine released by Novartis [34] Updated 23 Jan 2018
29 Nov 2017 Scientific Update Efficacy data from the phase III STRIVE trial in Migraine (prevention) released by Amgen [45] Updated 01 Dec 2017
08 Nov 2017 Trial Update Amgen completes a phase I trial for Migraine (Prevention) in USA, Belgium and Netherlands (SC) (NCT02542605) Updated 21 Dec 2017
06 Nov 2017 Trial Update Novartis Pharmaceuticals plans the phase III EMPOwER trial in Migraine (Prevention) (SC) (CAMG334A2302; NCT03333109) Updated 01 Mar 2018
07 Sep 2017 Scientific Update Safety and efficacy data from the phase II Treadmill Cardiovascular safety trial released by Amgen [62] Updated 11 Sep 2017
07 Sep 2017 Scientific Update Updated efficacy data from a phase II trial in Migraine released by Amgen [62] Updated 11 Sep 2017
20 Jul 2017 Regulatory Status FDA assigns PDUFA action date of 17/05/2018 for erenumab for Migraine (Prevention) [13] Updated 21 May 2018
20 Jul 2017 Regulatory Status The US FDA accepts BLA for erenumab for Migraine for review [13] Updated 21 Jul 2017
21 Jun 2017 Regulatory Status The European Medicines Agency (EMA) accepts marketing authorisation application (MAA) for erenumab for Migraine for review [14] Updated 25 Jun 2017
19 Jun 2017 Trial Update Amgen completes the phase III STRIVE trial in Migraine (Prevention) in USA, Austria, Belgium, Canada, Czech Republic, Finland, Germany, Hungary, Netherlands, Sweden, Slovakia, Poland, Turkey and United Kingdom(NCT02456740) Updated 04 Jul 2017
31 May 2017 Phase Change - Preregistration Preregistration for Migraine (Prevention) in European Union (SC) [15] Updated 19 Jun 2017
26 May 2017 Trial Update Amgen completes an open-label extension phase II trial for Migraine (Prevention) in USA, Canada, Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden, United Kingdom (SC) (NCT02174861) Updated 12 Jun 2017
18 May 2017 Phase Change - Preregistration Preregistration for Migraine (Prevention) in USA (SC) [16] Updated 24 May 2017
24 Apr 2017 Licensing Status Amgen and Novartis agree to co-promote erenumab in USA [2] Updated 02 May 2017
22 Apr 2017 Scientific Update Efficacy data from a phase I trial in Healthy volunteers presented at the 69th Annual Meeting of the American Academy of Neurology (AAN-2017) [70] Updated 13 Jun 2017
13 Apr 2017 Trial Update Amgen completes a phase II cardiovascular safety trial in USA, Slovakia, Bulgaria, Germany, Latvia, Czech Republic, Poland, New Zealand, Romania, South Africa and Switzerland (IV) (NCT02575833) Updated 25 May 2017
20 Mar 2017 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Australia (SC) (NCT03096834) Updated 23 Jan 2018
20 Mar 2017 Trial Update Novartis initiates enrolment in the LIBERTY trial for Migraine (Prevention) in France, Italy, Norway and Switzerland after March 2017 (NCT03096834) Updated 23 Jan 2018
20 Mar 2017 Trial Update Amgen completes a phase III trial in Migraine (Prevention) in USA, Denmark, France, Greece, Portugal, Russia, Switzerland (NCT02483585) Updated 03 Apr 2017
16 Nov 2016 Scientific Update Safety and efficacy data from the phase III STRIVE trial in Migraine (Prevention) released by Amgen [42] Updated 22 Nov 2016
16 Nov 2016 Trial Update Amgen completes enrolment in the phase III STRIVE clinical trials in Migraine (Prevention) in Czech Republic, United Kingdom, Turkey, Slovakia, Netherlands, Belgium, Poland, Canada, USA, Austria, Finland, Germany, Sweden, Hungary before November 2016 (NCT02456740) Updated 22 Nov 2016
31 Oct 2016 Trial Update Novartis initiates enrolment in the phase III LIBERTY trial in Migraine (Prevention) in United Kingdom, Sweden, Germany, Greece and the Netherlands (EudraCT2016-002211-18) Updated 03 Apr 2017
31 Oct 2016 Trial Update Novartis initiates enrolment in the phase III LIBERTY trial in Migraine (Prevention) in Czech Republic, Finland, and Denmark (EudraCT2016-002211-18) Updated 22 Nov 2016
22 Oct 2016 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Spain (SC) (EudraCT2016-002211-18) Updated 27 Oct 2016
20 Oct 2016 Trial Update Novartis Pharma initiates the phase III LIBERTY trial for Migraine (Prevention) in Austria (SC) (EudraCT2016-002211-18) Updated 26 Oct 2016
28 Sep 2016 Scientific Update Efficacy and safety data from the ARISE (Phase III) trial in Migraine released by Amgen [47] Updated 03 Oct 2016
15 Sep 2016 Scientific Update Efficacy and adverse events data from a phase II trial in Migraine (Prevention) released by Amgen [65] Updated 19 Sep 2016
01 Sep 2016 Trial Update Amgen completes a phase I drug-drug interaction trial in Healthy female volunteers in USA (unspecified) (NCT02792517) Updated 18 Oct 2016
01 Aug 2016 Trial Update Amgen completes a phase I trial in Healthy volunteers in Belgium (NCT02741310) Updated 26 Sep 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for phase-I development in Hot-flashes in USA (SC, Injection) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for phase-I development in Migraine in Belgium (IV) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for phase-I development in Migraine in Belgium (SC, Injection) Updated 16 Jul 2016
08 Jun 2016 Scientific Update Efficacy and adverse events data from a phase II trial in Migraine (Prevention) released by Amgen [66] Updated 13 Jun 2016
30 Apr 2016 Trial Update Amgen completes a phase II trial for Migraine (Prevention) in USA, Canada, Denmark, Finland, Germany, Norway and Sweden (NCT02066415, EudraCT2013-001707-36) Updated 06 Jun 2016
01 Feb 2016 Trial Update Amgen initiates a phase I drug-drug interaction trial in Healthy female volunteers in USA (unspecified) (NCT02792517) Updated 09 Jun 2016
01 Feb 2016 Trial Update Amgen initiates enrolment in a phase I trial in Healthy volunteers in Belgium (NCT02741310) Updated 20 Apr 2016
01 Jan 2016 Phase Change - II Phase-II clinical trials in Migraine (Prevention) in Japan (SC) (NCT02630459) Updated 18 Dec 2015
23 Nov 2015 Trial Update Amgen initiates a phase II cardiovascular safety trial in USA, Slovakia, Bulgaria, Germany, Latvia, Czech Republic, Poland, New Zealand, Romania, South Africa and Switzerland (IV) (EudraCT2015-002322-40) (NCT02575833) Updated 15 Sep 2017
11 Nov 2015 Trial Update Amgen initiates enrolment in a phase I trial for Migraine (Prevention) in Belgium and Netherlands(SC) (NCT02542605) Updated 21 Dec 2017
01 Nov 2015 Trial Update Amgen initiates a phase I trial for Migraine (Prevention) in USA (SC) (NCT02542605) Updated 03 Dec 2015
14 Oct 2015 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Denmark (SC) Updated 19 Oct 2015
07 Oct 2015 Trial Update Amgen plans a phase II cardiovascular safety trial in USA (NCT02575833) Updated 26 Oct 2015
07 Oct 2015 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Sweden (SC) Updated 19 Oct 2015
10 Sep 2015 Trial Update Amgen plans to initiate a phase I trial for Migraine (Prevention) in USA (NCT02542605) Updated 10 Sep 2015
01 Sep 2015 Licensing Status AMG 301 licensed to Novartis worldwide excluding, USA, Canada and Japan [1] Updated 07 Sep 2015
20 Jul 2015 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in France, Greece, Portugal, Russia, Switzerland (SC) (NCT02483585) Updated 03 Apr 2017
20 Jul 2015 Trial Update Amgen initiates a phase III trial in Migraine (Prevention) in Spain (NCT02483585) Updated 03 Apr 2017
02 Jul 2015 Trial Update Amgen plans the phase III ARISE trial in Migraine in USA, Denmark, Spain, Portugal, Russia, France, Greece, Switzerland and Mexico (NCT02483585) Updated 02 Jul 2015
01 Jul 2015 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Czech Republic, United Kingdom, Turkey, Slovakia, Netherlands, Belgium (SC) after July 2015 (NCT02456740) Updated 22 Nov 2016
01 Jul 2015 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Poland, Canada, USA (SC) after July 2015 (NCT02456740) Updated 10 Sep 2015
01 Jul 2015 Trial Update Amgen initiates enrolment in a phase III trial for Migraine (Prevention) in USA (NCT02483585) Updated 10 Sep 2015
25 Jun 2015 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Germany, Austria and Hungary (SC) Updated 19 Oct 2015
25 Jun 2015 Phase Change - III Phase-III clinical trials in Migraine (Prevention) in Finland (SC) (EudraCT2014-004464-38) Updated 02 Jul 2015
19 Jun 2015 Scientific Update Interim efficacy and adverse events data from a phase II long-term extension trial in Migraine (Prevention) released by Amgen [57] Updated 04 Jul 2015
15 May 2015 Scientific Update Efficacy and adverse events data from a phase II trial in Migraine (Prevention) released by Amgen [53] Updated 30 May 2015
27 Jan 2015 Trial Update Amgen completes a phase II trial in Migraine (Prevention) in USA, Canada, Denmark, Finland, Germany, Norway and Sweden [52] (NCT01952574) Updated 02 Feb 2015
01 Oct 2014 Trial Update Amgen completes a phase I trial in Hot flashes in USA (SC) (NCT01890109) Updated 02 Dec 2014
01 Jul 2014 Trial Update Amgen completes a phase I trial in Migraine in Belgium (NCT01723514) Updated 05 Sep 2014
30 Jun 2014 Trial Update Amgen initiates enrolment in a phase II trial for Migraine (Prevention) in USA, Canada, Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden, United Kingdom (SC) (NCT02174861) Updated 04 Jul 2015
28 May 2014 Trial Update Amgen initiates enrolment in a phase II trial for Migraine (prevention) in Denmark (EudraCT2013-005311-27) Updated 22 Jul 2014
26 Feb 2014 Trial Update Amgen initiates enrolment in a phase II trial for Migraine (prevention) in Germany and Norway (EudraCT2013-001707-36) Updated 06 Jun 2014
17 Feb 2014 Trial Update Amgen plans a phase II trial for Migraine (prevention) in the US, Canada and the EU (NCT02066415) Updated 27 Feb 2014
01 Feb 2014 Phase Change - II Phase-II clinical trials in Migraine (Prevention) in Poland and Czech Republic (SC) Updated 02 Feb 2015
01 Feb 2014 Trial Update Amgen initiates enrolment in a phase II trial for Migraine (Prevention) in USA, Canada, Denmark, Finland, Germany, Norway and Sweden (NCT02066415, EudraCT2013-001707-36) Updated 02 Feb 2015
25 Nov 2013 Trial Update Amgen terminates phase I trial in Migraine in Belgium (NCT01688739) Updated 03 Dec 2013
01 Aug 2013 Phase Change - II Phase-II clinical trials in Migraine (Prevention) in Canada (SC) Updated 02 Feb 2015
01 Aug 2013 Phase Change - II Phase-II clinical trials in Migraine (Prevention) in USA (SC) Updated 02 Feb 2015
01 Aug 2013 Phase Change - II Phase-II clinical trials in Migraine (prevention) in Denmark (SC) after August 2013 Updated 06 Jun 2014
01 Aug 2013 Phase Change - II Phase-II clinical trials in Migraine (prevention) in Germany, Norway and Sweden (SC) after August 2013 Updated 27 Feb 2014
01 Aug 2013 Phase Change - II Phase-II clinical trials in Migraine (prevention) in Finland (SC) Updated 23 Jul 2013
01 May 2013 Phase Change - I Phase-I clinical trials in Hot flashes in USA (SC) (NCT01890109) Updated 16 Jul 2013
30 Nov 2012 Trial Update Amgen initiates enrolment in a phase I trial for Migraine in Belgium (NCT01723514) Updated 22 Jan 2013
07 Nov 2012 Trial Update Amgen plans a phase I trial for Migraine in Belgium (NCT01723514) Updated 04 Dec 2012
31 Mar 2012 Phase Change - I Phase-I clinical trials in Migraine in Belgium (IV) Updated 04 Dec 2012
31 Mar 2012 Phase Change - I Phase-I clinical trials in Migraine in Belgium (SC) Updated 04 Dec 2012

References

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  14. Novartis achieves important regulatory milestone for AMG 334 (erenumab) in migraine prevention with EMA filing acceptance.

    Media Release
  15. Novartis presents data demonstrating efficacy of AMG 334 (erenumab) in migraine prevention at the American Headache Society Annual Meeting.

    Media Release
  16. Amgen Submits Biologics License Application To The FDA For Erenumab.

    Media Release
  17. Novartis' CGRP inhibitor Aimovig(R) (erenumab) now available in Canada for the prevention of migraine i.

    Media Release
  18. Aimovig(TM) (erenumab), a novel treatment developed specifically for migraine prevention receives Health Canada approval(i) Francais.

    Media Release
  19. Novartis delivered strong growth and innovation during the third quarter, including progressing advanced therapy platforms to drive future growth.

    Media Release
  20. Novartis marks a new era for migraine patients with the EU approval of Aimovig(R)a first-of-its-kind treatment specifically designed for migraine prevention.

    Media Release
  21. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018.

    Media Release
  22. Novartis receives positive CHMP opinion for Aimovig(R)(erenumab) for the prevention of migraine.

    Media Release
  23. Amgen Announces Approval Of Aimovig(R)(Erenumab) In Japan For The Suppression Of Onset Of Migraine Attacks In Adults.

    Media Release
  24. Amgen Reports Third Quarter 2020 Financial Results.

    Media Release
  25. Ashina M, Reuter U, Dodick D, Zhang F, Ritter S, Stites T, et al. Long-term Safety and Tolerability of Erenumab In Episodic Migraine: A Pooled Analysis From Two Clinical Trials and Their Extension Phases. AAN-2022 2022; abstr. P3.005.

    Available from: URL: https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-000324.html
  26. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])

    ctiprofile
  27. A Phase 3, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])

    ctiprofile
  28. A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention

    ctiprofile
  29. A 12-week Double-blind, Randomized, Multi-center Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients (EMPOwER)

    ctiprofile
  30. Wang S-J, Roxas Jr AA, Saravia B, Kim B-k, Chowdhury D, Riachi N, et al. Effect of Erenumab on Patient-Reported Outcomes in Patients With Episodic Migraine From Asia, the Middle East and Latin America: The EMPOwER Study. AAN-2022 2022; abstr. P16.006.

    Available from: URL: https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-001543.html
  31. Reuter U, Goadsby P, Lanteri-Minet M, Hours-Zesiger P, Fernandes C, Ferrari M, et al. Assessment of the Efficacy of Erenumab During the Open-Label Treatment (13-24 Weeks) of Subjects with Episodic Migraine Who Failed 2-4 Prior Preventive Treatments: Results of the LIBERTY Study. AAN-2019 2019; abstr. P1.10-002.

    Available from: URL: https://n.neurology.org/content/92/15_Supplement/P1.10-002
  32. Novartis data underpin long-term efficacy of Aimovig(R)where other treatments have failed.

    Media Release
  33. Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig(T) (erenumab) For Migraine Patients With Multiple Treatment Failures.

    Media Release
  34. Novartis reports erenumab met all primary and secondary endpoints in unique Phase IIIb study in episodic migraine patients who have failed multiple prior preventive treatments.

    Media Release
  35. Amgen Reports Aimovig(TM) (Erenumab) Met All Primary And Secondary Endpoints In Unique Phase 3b Study In Episodic Migraine Patients Who Have Failed Multiple Prior Preventive Treatments.

    Media Release
  36. A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

    ctiprofile
  37. Amgen Announces Five-Year Data That Reinforce The Safety And Efficacy Profile Of Aimovig(Rm) (erenumab-aooe) In Adult Patients With Episodic Migraine.

    Media Release
  38. Reuter U, Goadsby P, Ferrari M, da Silva Lima GP, Mondal S, Wen S, et al. Three-Year Efficacy and Safety of Erenumab in Participants with Episodic Migraine and 2-4 Prior Preventive Treatment Failures: Results from the LIBERTY Study. AAN-2022 2022; abstr. N/A.

    Available from: URL: https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-001100.html
  39. Chou DE, Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, et al. Sustained Efficacy Over 1 Year of Treatment With Erenumab: Results From the Extension Phase of the STRIVE Study in Episodic Migraine. AAN-2019 2019; abstr. S38.005.

    Available from: URL: https://n.neurology.org/content/92/15_Supplement/S38.005
  40. Novartis data show Aimovig(R)cuts acute migraine medication days by half in patients who failed prior preventive therapies.

    Media Release
  41. Amgen To Highlight Extensive Long-Term Safety And Efficacy Data Of Aimovig(Rm) (erenumab-aooe) Across The Spectrum Of Migraine At AAN Annual Meeting.

    Media Release
  42. Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In Second Phase 3 Study.

    Media Release
  43. A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

    ctiprofile
  44. McAllister P, Gomez JP, McGill L, Newman L, Tassorelli C, Zhang F, et al. Efficacy of Erenumab For the Treatment of Patients with Episodic Migraine with Aura. AAN-2018 2018; abstr. 094.

    Available from: URL: https://submissions.mirasmart.com/AAN2018/itinerary/SearchHome.asp
  45. Aimovig(T) (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention.

    Media Release
  46. A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

    ctiprofile
  47. Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In First Phase 3 Study.

    Media Release
  48. Amgen's First Quarter 2016 Revenues Increased 10 Percent To $5.5 Billion And Adjusted Earnings Per Share (EPS) Increased 17 Percent To $2.90.

    Media Release
  49. Wang S-J, Kim B-K, Wang H, Zhou J, Wan Q, Yu T, et al. Efficacy and Safety of Erenumab 70 mg in Adult Patients with Chronic Migraine: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled DRAGON Study. AAN-2022 2022; abstr. S31.005.

    Available from: URL: https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-002527.html
  50. A 12-week Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Once Monthly Subcutaneous Erenumab 70 mg in Adult Chronic Migraine Patients

    ctiprofile
  51. A Placebo-Controlled, Double-Blind, Randomized, Proof-of-Concept Study to Evaluate the Efficacy and Tolerability of Erenumab in Patients with Trigeminal Neuralgia

    ctiprofile
  52. Amgen's 2014 Revenues Increased 7 Percent To $20.1 Billion And Adjusted Earnings Per Share (EPS) Increased 14 Percent To $8.70.

    Media Release
  53. Amgen Presents First Phase 2 Data For AMG 334 In The Prevention Of Episodic Migraine.

    Media Release
  54. Ashina M, Goadsby P, Reuter U, Silberstein S, Dodick D, Xue F, et al. Sustained Efficacy and Long-term Safety of Erenumab in Patients with Episodic Migraine: 4+ Year Results of a 5-year, Open-label Treatment Period. AAN-2020 2020; abstr. N/A.

    Available from: URL: https://index.mirasmart.com/AAN2020/PDFfiles/AAN2020-001203.html
  55. Novartis data confirm long-term efficacy and safety of Aimovig(Rm) for majority of patients with episodic migraine.

    Media Release
  56. Amgen And Novartis Present New Data Demonstrating Long-Term Efficacy, Safety And Tolerability Of Aimovig(Tm) (erenumab-aooe) In Patients With Chronic And Episodic Migraine.

    Media Release
  57. Amgen Presents Open-Label Extension Data From Ongoing Phase 2 Study Of AMG 334 In The Prevention Of Episodic Migraine.

    Media Release
  58. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

    ctiprofile
  59. Ashina M, Goadsby P, Reuter U, Silberstein S, Dodick D, Zhang F, et al. Consistent efficacy and safety of erenumab over time in patients with episodic migraine who completed a 5-year, open-label extension study. AAN-2021 2021; abstr. P10.001.

    Available from: URL: https://index.mirasmart.com/AAN2021/PDFfiles/AAN2021-002328.html
  60. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

    ctiprofile
  61. ERENUMAB PHASE 2 STUDY DEMONSTRATES SIGNIFICANT EFFICACY IN MIGRAINE PREVENTION IN JAPANESE PATIENTS.

    Media Release
  62. New Data Demonstrate Aimovig(Tm) (erenumab) Reduced Monthly Migraine Days In Patients Who Failed Previous Preventive Therapies.

    Media Release
  63. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention

    ctiprofile
  64. An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334

    ctiprofile
  65. Amgen Presents Positive Data At EHMTIC 2016 Demonstrating Erenumab Significantly Reduces Monthly Migraine Days In Patients With Chronic Migraine.

    Media Release
  66. Amgen Announces Erenumab (AMG 334) Significantly Reduces Patients' Monthly Migraine Days In Phase 2 Study For The Prevention Of Chronic Migraine.

    Media Release
  67. Lipton R, Tepper S, Silberstein S, Kudrow D, Ashina M, Reuter U, et al. Conversion from Chronic Migraine (CM) to Episodic Migraine (EM) With Long-Term Erenumab Treatment. AAN-2019 2019; abstr. S17.008.

    Available from: URL: https://n.neurology.org/content/92/15_Supplement/S17.008
  68. A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

    ctiprofile
  69. A Multi-Center, Open-label, Pharmacokinetic Drug Interaction Study of AMG 334 and a Combined Oral Contraceptive in Healthy Female Subjects

    ctiprofile
  70. de Hoon J, Van Hecken A, Vandermeulen C, Herbots M, Kubo Y, Lee E, et al. Phase 1, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Erenumab (AMG 334) and Concomitant Sumatriptan on Blood Pressure in Healthy Subjects. AAN-2017 2017; abstr. 813.

    Available from: URL: http://submissions.mirasmart.com/AAN2017/itinerary/login.asp
  71. Phase 1, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effect on Blood Pressure of AMG 334 Given Concomitantly With Subcutaneous Sumatriptan (Imitrex) in Healthy Subjects

    ctiprofile
  72. Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients

    ctiprofile
  73. Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and in Migraine Patients

    ctiprofile
  74. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and Migraine Patients

    ctiprofile
  75. An Open Label Study to Evaluate the Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Headache Attributed to Mild Traumatic Injury to the Head

    ctiprofile
  76. Erenumab as a Therapeutic Approach for the Management of Trigeminal Neuropathic Pain (TNP)

    ctiprofile
  77. Erenumab as a Therapeutic Approach for the Management of Painful Chronic Temporomandibular Disorders (TMD)

    ctiprofile
  78. A Randomized, Double Blind, Placebo-Controlled Single Center Phase 2 Pilot Study to Assess the Safety and Efficacy of Off-label Subcutaneous Administration of Erenumab-aooe in Patients With Temporomandibular Disorder

    ctiprofile
  79. Randomized, Stratified, Parallel-group, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 334 in Women With Hot Flashes Associated With Menopause

    ctiprofile
  80. A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of AMG 334 on Exercise Time During a Treadmill Test in Subjects With Stable Angina

    ctiprofile
  81. An Open Label Study to Evaluate the Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea

    ctiprofile
  82. Amgen Inc - ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. Internet-Doc 2022;.

    Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/318154/000031815423000017/amgn-20221231.htm
  83. Novartis Form 20-F, January 2018. Internet-Doc 2018;.

    Available from: URL: https://www.sec.gov/Archives/edgar/data/1114448/000104746918000380/a2234185z20-f.htm
  84. Novartis -Q2 report. Internet-Doc 2020;.

    Available from: URL: https://ml-eu.globenewswire.com/resource/download/bed749ce-ebd9-4018-ab0d-27d775c7c2c8
  85. Pavlovic J, Paemeleire K, Gobel H, Bonner J, Rapoport A, Zhang F, et al. Efficacy of Erenumab in Women With and Without a History of Menstrually-Related Migraine. AAN-2018 2018; abstr. 096.

    Available from: URL: https://submissions.mirasmart.com/AAN2018/itinerary/SearchHome.asp
  86. Vargas B, Starling A, Silberstein S, Zhou Y, Trotman M-L, Xue F, et al. Erenumab Immunogenicity: a Pooled Analysis of Phase 2 and Phase 3 Migraine Prevention Clinical Trials. AAN-2018 2018; abstr. 098.

    Available from: URL: https://submissions.mirasmart.com/AAN2018/itinerary/SearchHome.asp
  87. Tepper S, Pascual J, Reuter U, Picard H, Hong F, Trotman M-L, et al. Analysis of Blood Pressure Following Short-Term and Long-Term Treatment with Erenumab. AAN-2018 2018; abstr. 103.

    Available from: URL: https://submissions.mirasmart.com/AAN2018/itinerary/SearchHome.asp
  88. Novartis presents first-of-its-kind evidence at AAN reinforcing robust and consistent efficacy of AimovigTM* (erenumab) for migraine patients with multiple treatment failures.

    Media Release
  89. Novartis announces Phase III study shows AMG 334 significantly reduces monthly migraine days in people with episodic migraine.

    Media Release
  90. Novartis presents new positive data at EHMTIC showing AMG 334 significantly reduces monthly migraine days in chronic migraine.

    Media Release
  91. Amgen Reports First Quarter 2018 Financial Results.

    Media Release
  92. Tepper S, Widnell K, Dolezil D, Ashina M, Reuter U, Brandes JL, et al. Evaluating the Efficacy and Safety of Erenumab (AMG 334) In Chronic Migraine Prevention in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study. AAN-2017 2017; abstr. 1200.

    Available from: URL: http://submissions.mirasmart.com/AAN2017/itinerary/login.asp
  93. Amgen Presents Erenumab Data At The 59th Annual Scientific Meeting of the American Headache Society.

    Media Release
  94. Emerging Migraine Therapies Show Promise in Basic and Clinical Highlights Presented at 18th Congress of the International Headache Society Sept. 7-10.

    Media Release
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