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Bamlanivimab - Abcellera/Eli Lilly and Company

Drug Profile

Bamlanivimab - Abcellera/Eli Lilly and Company

Alternative Names: LY 3819253; LY CoV 555

Latest Information Update: 11 Feb 2021

At a glance

  • Originator Abcellera; Eli Lilly and Company
  • Developer Abcellera; Eli Lilly and Company; National Institute of Allergy and Infectious Diseases
  • Class Antivirals; Monoclonal antibodies
  • Mechanism of Action Virus internalisation inhibitors
  • 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

  • Registered COVID 2019 infections

Most Recent Events

  • 09 Feb 2021 Registered for COVID-2019 infections (Combination therapy) in Italy (IV)
  • 09 Feb 2021 Registered for COVID-2019 infections (Combination therapy, In adolescents, In the elderly, In adults) in USA (IV)
  • 09 Feb 2021 The US FDA authorizes shortened infusion times for bamlanivimab alone and in combination with etesevimab

Development Overview

Introduction

Bamlanivimab (formerly known as LY CoV 555, LY 3819253) is a recombinant, neutralising human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2, being developed by Eli Lilly and AbCellera, in collaboration with National Institute of Allergy and Infectious Disease, for the treatment and prevention of COVID-2019 infections. Bamlanivimab has been developed using AbCellera's pandemic response platform, which is a microfluidic platform that uses miniaturised assays to screen antibodies from individual B cells from any species, including directly from human patients. Bamlanivimab neutralises the virus and potentially prevents and treats COVID-2019 by blocking the viral attachment and entry into human cells. It is also capable of neutralising the N439K variant. Bamlanivimab is available in the US under emergency authorization, in Canada under interim authorization, and in Italy, for COVID-2019 infections. Bamlanivimab, alone and in combination with etesevimab, is under rolling review in the EU. Late stage clinical development is underway in Puerto Rico.

Bamlanivimab has advanced from a research programme for coronavirus neutralising antibodies by Eli Lilly and AbCellera [See Adis Insight drug profile 800057369].

Company Agreements

In January 2021, Eli Lilly, Vir Biotechnology and GlaxoSmithKline entered an agreement to evaluate bamlanivimab in combination with VIR 7831 for mild to moderate COVID-2019 infections. Eli Lilly will expand its ongoing BLAZE-4 trial to evaluate the efficacy of combined therapy. [1]

In December 2020, Eli Lilly and Company entered into partnership with UnitedHealth Group (UnitedHealthcare Services) to conduct a pragmatic study of bamlanivimab in high-risk, COVID-2019 infected patients that meet Emergency Use Authorization (EUA) criteria as per the US FDA. Under the study design, UnitedHealth Group with its Optum health services will conduct a study in real world settings, which will detect high-risk symptomatic patients with COVID-2019 infections, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home treatment with bamlanivimab infusion. The aim of the collaborative endeavour is to reduce the severity of illness and hospitalisations. The study will enroll up to 500 000 patients, with at least 5 000 people expected to receive bamlanivimab therapy. [2]

As of December 2020, Eli Lilly and Company has entered to a supply agreement with the US government, to supply multiple doses of Eli Lilly's bamlanivimab 700 mg for the treatment of COVID-2019 infections. The agreement is for $US812.5 million and the doses will be delivered through January 2021. In December 2020, The U.S. government has purchased 650 000 additional drug doses, the totaling to 950 000 doses of bamlanivimab. Additional 350 000 doses will delivered later in the same month. [3]

In November 2020, Samsung Biologics and Eli Lilly and Company entered into a long-term manufacturing agreement to accelerate global supply of COVID-19 antibody treatments. This agreement with Samsung supplements Lilly's own internal manufacturing capacity. Lilly and Samsung Biologics entered into the manufacturing partnership agreement in May 2020 to address the demand for COVID-19 treatments worldwide. Samsung was able to manufacture and deliver an initial supply of Active Pharmaceutical Ingredients (API) meeting Good Manufacturing Practices (GMP) and regulatory expectations within 5 months of contract signing. The timeline for tech transfer was less than 3 months [4]

In September 2020, Eli Lilly and Company and Amgen entered a global antibody manufacturing collaboration to increase the supply capacity available for Lilly's potential COVID-19 therapies, including LY-CoV-555. Amgen will leverage its technical expertise in antibody development and its capabilities in the scale up and manufacturing of complex biologics. Further details of the agreement were not disclosed. [5]

In July 2020, Sanford Burnham Prebys Medical Discovery Institute entered into an research agreement with Eli Lilly and Company to characterize Lilly’s next-generation anti-SARS-CoV-2 antibodies. The research team will evaluate antibody candidates, delivered from Lilly through their partnership with AbCellera, using the live virus in the Institute’s Biosafety Level 3 (BSL-3) laboratory. [6]

In March 2020, Abcellera and Eli Lilly entered into a research and development agreement to develop antibodies for up to nine Eli Lilly-selected therapeutic targets. One of therapeutic targets is for treatment and prevention of COVID-19 infections, caused by SARS-CoV-2 coronavirus. Eli Lilly will select up to eight additional targets during the multi-year agreement. Abcellera's rapid pandemic response platform developed under the DARPA Pandemic Prevention Platform (P3) programme will be used in this collaboration along with Eli lilly's rapid development, manufacturing and distribution of therapeutic antibodies. Under the terms of agreement Abcellera and Eli lilly will together fund the initial development cost of the product, after which Eli lilly will be responsible for all further development, manufacturing and distribution. Eli lilly has paid AbCellera an up-front payment and will pay preclinical, clinical, and commercial milestones and tiered royalties on future sales. [7] [8]

Key Development Milestones

As at February 2021, the bamlanivimab plus etesevimab [see Adis Insight Drug profile 800058525] regimen was authorized for use in Italy, for the treatment of mild to moderate COVID-2019 infections [9] . In February 2021, the European Medical Agency's (EMA) human medicines committee (CHMP) started a rolling review of data on the use of bamlanivimab alone and in combination with etesevimab for the treatment of COVID-19 patients who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The CHMP decision to start rolling review based on preliminary results from a study indicates that reduced the viral load in the back of the nose and throat of non hospitalized patients with COVID-19 who do not need supplementation oxygen [10] .

In November 2020, AbCellera announced that bamlanivimab 700 mg received an emergency use authorization (EUA) from the US FDA. Bamlanivimab is authorised for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older with positive results of direct SARS-CoV-2 viral testing, who weigh at least 40 kg and are at high risk for progressing to severe COVID-19 and/or hospitalisation. The EUA is based on data from the two randomised trials namely; BLAZE-1 and BLAZE-2 [see below]. In February 2021, the infusion time was authorized at 16 minutes, significantly reduced from the previously approved time of 60 minutes [9] [11] . As of October 2020, Eli Lilly and Company submitted an initial request for emergency use authorization (EUA) to US FDA for bamlanivimab (LY CoV555) monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19 infection, based on the combination therapy data.

The US FDA, in February 2021, granted Emergency Use Authorization (EUA) for etesevimab [see Adis Insight Drug profile 800058525] and bamlanivimab combination therapy, for the treatment of mild to moderate COVID-2019 infection in high-risk patients aged 12 years and older who are high risk for progressing to severe COVID-2019 and/or hospitalization. The therapies are indicated to be infused together in a single IV infusion, as soon as possible after a positive test and within 10 days of symptom onset. The infusion time has been authorized at 21 minutes. The EUA request was submitted by Eli Lilly, in November 2020, based on the phase II/III BLAZE-1 trial data [see below] [9] [12] [13] .

In November 2020, Health Canada granted authorisation to bamlanivimab under the interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19, as a treatment for adults and paediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalisation. This authorisation was based on data from BLAZE-1 trial [see below] [14] .

As of November 2020, Eli Lilly was in discussions with global regulators including from India, Brazil, Russia and Europe for pursuing authorisation of bamlanivimab for COVID-2019 infections [14] .

In December 2020, Eli Lilly and company in collaboration with UnitedHealth Group, initiated the pragmatic UNITED trial to assess the efficacy and safety of bamlanivimab versus a propensity matched cohort for the treatment of symptomatic, high-risk COVID-2019 patients in the outpatient setting (2020-0081; NCT04639479). Trial participants will track for symptom development and in-home SARS-CoV-2 testing. If positive, the patients will receive a one-time at-home infusion of bamlanivimab, 700mg. The primary objective is to determine the incidence of COVID-2019 related hospitalisation at day 28 among bamlanivimab-treated participants relative to external, propensity-matched controls. The trial will also evaluate the incidence of COVID-related mortality at day 28, as well as safety of bamlanivimab. The trial is intended to enroll up to 500 000 patients, with at least 5 000 expected to receive bamlanivimab therapy [2] [15] .

In November 2020, Eli Lilly and company completed an expanded access programme for COVID-2019 infections in the US. In October 2020, Eli Lilly Company initiated an expanded access programme for COVID-2019 infections in the US (18165; J2X-MC-Y001; NCT04603651) [16] .

In August 2020, National Institute of Allergy and Infectious Diseases and Eli Lilly initiated the phase II/III Adapt Out COVID trial to evaluate the safety and efficacy of bamlanivimab (LY CoV 555, LY 3819253), as compared with a placebo constituted of a 0.9% sodium chloride solution, for the treatment of COVID-19 infections (NCT04518410; ACTIV-2; ACTIV2; A5401; 38742; DAIDS-ES). The randomised trial intends to enrol 2 000 patients in the US and Puerto Rico [17] .

In August 2020, National Institute of Allergy and Infectious Diseases initiated phase III TICO trial to evaluate the safety and efficacy of bamlanivimab and standard of care drug remdesivir [see Adis Insight Drug profile800043325] for the treatment of COVID-19 infections (NCT04501978; ACTIV-3; 014; 014ACTIV3). The primary endpoint of the trial is sustained recovery of the participants for 14 days, following release from the hospital. The randomised, blinded, controlled, multicentre trial intends to enrol 10 000 patients in USA [18] . In October 2020, Independent data safety monitoring board (DSMB) recommended to pause enrolment in its ongoing phase III trial [19] .

In August 2020, Eli Lilly, in collaboration with AbCellera Biologics and National Institute of Allergy and Infectious Diseases, initiated a phase III BLAZE-2 trial to evaluate bamlanivimab to prevent COVID-2019 infections (NCT04497987; 18063; J2X-MC-PYAD; CoVPN #3501). The randomised study will include up to 2,400 participants and assess the ability of bamlanivimab to prevent infection of long-term care residents and facility staff who have been exposed to SARS-CoV-2 in the US and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). In August 2020, National Institute of Allergy and Infectious Diseases reported that enrollment of healthy adults who are at risk of infection due to close contact at work or home to persons with SARS-CoV-2 infection in the trial has been initiated in the US [20] [21] [22] . In January 2021, results from the trial were released by the company [23] [24] . In January 2021, efficacy data from a trial in COVID-2019 infections was released by Eli Lilly and Company [25] .

In October 2020, Eli Lilly and Company initiated a phase II BLAZE-4 trial to evaluate the efficacy and safety of etesevimab (LY 3832479/LY CoV016) [see Adis Insight Drug profile800058525] and bamlanivimab (LY 3819253/LY CoV555) as monotherapy and combination therapy in patients with mild to moderate COVID-2019 infections (NCT04634409; J2X-MC-PYAH). The randomised, placebo-controlled trial is designed to enrol approximately 1000 patients in the US and Puerto Rico [26] [27] . In January 2021, Eli Lilly expanded the trial to evaluate bamlanivimab in combination with sotrovimab [see Adis Insight Drug profile800058114] in patients with mild to moderate COVID-2019 infections. Subsequently, first patient was dosed in the trial [1] . The combination regimen demonstrated effects similar to those observed in the phase III study [9] .

In January 2021, the phase II/III BLAZE-1 trial met the primary and secondary endpoints of the study by significantly reducing viral load and accelerated symptom resolution with the combination therapy of bamlanivimab and etesevimab, in patients with COVID-2019 infections (17947; J2W-MC-PYAB; NCT04427501). In June 2020, Eli Lilly, in collaboration with AbCellera Biologics, initiated the trial to evaluate safety and efficacy of bamlanivimab alone and in combination with etesevimab [see Adis Insight Drug profile 800058525]. The randomised, double-blind, placebo-controlled trial intends to enrol approximately 3 300 patients in the US and Puerto Rico [28] . In September 2020, interim safety and efficacy results from the trial were released by the company [29] . In October 2020, the company released the interim analysis of the trial [13] . In January 2021, the company released additional data from the trial [12] .

In August 2020, Eli Lilly completed a phase I trial that evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of bamlanivimab in patients with COVID-2019 infections (17823; J2W-MC-PYAA; NCT04411628). The randomised, double-blind placebo-controlled trial was initiated in May 2020 and enrolled approximately 24 patients in the US [30] . As of July 2020, dosing has been completed in the trial. In September 2020, Eli Lilly has successfully completed enrollment in the trial and primary safety assessments of LY CoV 555 [29] [31] [32] .

In December 2020, Eli Lilly and Company completed a phase I trial that evaluated the pharmacokinetics, safety, and tolerability of bamlanivimab, administered subcutaneously in healthy volunteers (NCT04537910; 18124; J2X-MC-PYAG). The randomised, placebo-controlled, double-blind study was initiated in September 2020,and enrolled approximately 25 volunteers in the US [33] .

As of March 2020, early research development for COVID-2019 treatment is underway in Canada [7] .

In October 2020, Eli Lilly and Company entered into an agreement with Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, to provide access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19 infections, to benefit low and middle-income countries [34] .

In October 2020, Eli Lilly and Company entered into a supply agreement with the US government to meet Operation Warp Speed goals. As per agreement Lilly will supply 300,000 vials of bamlanivimab 700mg for COVID-19 for $US375 million. The initial agreement is for delivery over the two months following an Emergency Use Authorization (EUA) by the US Food and Drug Administration and also provides the option for the US government to purchase up to an additional 650,000 vials through June 30, 2021, under the same terms as the base agreement and subject to agreement from Lilly, product availability and the medical need in the US. Lilly is partnering with Operation Warp Speed and a national distributor to finalise distribution plans and shipping preparations. Lilly is also working with Operation Warp Speed to assist US federal and state agencies in the identification and creation of options for locations where patients can receive this medication that are accessible and minimise infection transmission [35] .

Drug Properties & Chemical Synopsis

  • Route of administration IV, SC
  • Formulation Infusion, Injection
  • Class Antivirals, Monoclonal antibodies
  • Target Coronavirus spike glycoprotein; Virus internalisation
  • Mechanism of Action Virus internalisation inhibitors
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

  • CAS Registry Number 2423943-37-5

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections For bamlanivimab and etesevimab combination Combination therapy Registered Italy IV / Infusion Abcellera, Eli Lilly and Company 09 Feb 2021
COVID 2019 infections emergency use authorisation for individuals aged 12 years and older In adolescents, In adults, In children, In the elderly, Monotherapy Registered USA IV / Injection Abcellera, Eli Lilly and Company 09 Nov 2020
COVID 2019 infections Approved under EUA; in combination with JS 016 (LY-CoV016) Combination therapy, In adolescents, In adults, In the elderly Registered USA IV / Infusion Abcellera, Eli Lilly and Company 09 Feb 2021
COVID 2019 infections interim authorisation in individuals aged 12 years and older In adolescents, In adults, In children, In the elderly Registered Canada IV / Injection Abcellera, Eli Lilly and Company 20 Nov 2020
COVID 2019 infections Rolling review in EU for bamlanivimab and etesevimab combination Combination therapy Preregistration European Union IV / Infusion Abcellera, Eli Lilly and Company 04 Feb 2021
COVID 2019 infections rolling review in EU Monotherapy Preregistration European Union IV / Infusion Abcellera, Eli Lilly and Company 09 Feb 2021
COVID 2019 infections with standard of care drug remdesivir Combination therapy, In adults, In the elderly Phase III USA IV / Infusion National Institute of Allergy and Infectious Diseases 04 Aug 2020
COVID 2019 infections - Prevention Phase III USA IV / Injection Abcellera, National Institute of Allergy and Infectious Diseases, Eli Lilly and Company 03 Aug 2020
COVID 2019 infections - In adults, In the elderly Phase II/III Puerto Rico, USA IV / Infusion Eli Lilly and Company 19 Aug 2020
COVID 2019 infections in combination with etesevimab Combination therapy, In adults Phase II Puerto Rico IV / Infusion Eli Lilly and Company 29 Oct 2020
COVID 2019 infections - In adults, Monotherapy Phase II Puerto Rico IV / Infusion Eli Lilly and Company 29 Oct 2020
COVID 2019 infections - In adults, In volunteers Phase I USA SC / Injection Eli Lilly and Company 02 Sep 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Abcellera Originator Canada
Eli Lilly and Company Originator USA
Eli Lilly and Company Owner USA
Abcellera Owner Canada
Bill & Melinda Gates Foundation Funder USA
GlaxoSmithKline Collaborator United-Kingdom
Vir Biotechnology Collaborator USA
Sanford Burnham Prebys Medical Discovery Institute Collaborator USA
Shanghai Junshi Biosciences Collaborator China
National Institute of Allergy and Infectious Diseases Collaborator USA
UnitedHealth Group Collaborator USA

Scientific Summary

  • Adverse Events Occasional: Diarrhoea; Dizziness; Headache; Nausea; Pruritus; Vomiting

Adverse Events

Interim analysis of the randomised, double-blind, placebo-controlled, phase II/III BLAZE-1 trial in patients with COVID-19 infections showed that combination therapy of bamlanivimab (LY CoV555) and etesevimab (LY CoV016) was generally well tolerated and safety profile was consistent with observations from other phase I, phase II and phase III trials. Serious adverse events were reported at a similar frequency in the etesevimab and bamlanivimab together and placebo groups. No drug-related serious adverse events were reported. In bamlanivimab monotherapy studies, isolated drug-related infusion reactions or hypersensitivity were observed that were generally mild (two reported as serious infusion reactions, all patients recovered). Treatment emergent adverse events were comparable to placebo for both bamlanivimab monotherapy and combination therapy. Earlier results showed that adverse events reported in at least 1% of participants on bamlanivimab 700 mg and placebo were nausea (3% vs 4%), diarrhoea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%) [12] [13] [29] [14] [28] .

Bamlanivimab was safe and well tolerated in phase III BLAZE-2 trial in patients with COVID-2019 infections. Serious adverse events of similar frequency were reported in both placebo and bamlanivimab groups, as observed in phase I and phase II trials. No COVID-2019 related deaths were reported with bamlanivimab treatment [24] [22] .

Therapeutic Trials

Interim analysis of the phase II/III BLAZE-1 trial showed that combination therapy of bamlanivimab (LY CoV555) and etesevimab (LY CoV016) reduced viral load, symptoms and COVID-related hospitalisation and ER visits in patients recently diagnosed with mild to moderate COVID-19. Across 1 035 patients, there were 11 events (2.1%) in patients taking therapy and 36 events (7%) in patients taking placebo, representing a 70% risk reduction (p = 0.0004). There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking etesevimab and bamlanivimab together. The combination therapy significantly reduced viral load at day 11 (p = 0.011), met the primary and secondary endpoint endpoint of the study. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. The combination treatment reduced viral levels at day 3 (p = 0.016) and day 7 (p < 0.001). Combination therapy also significantly reduced the time-weighted average change from baseline from day 1 to 11. The combination therapy also met prespecified clinical endpoints, including the time-weighted average change from baseline in total symptom score from day 1 to 11 (p = 0.009). The improvement in symptoms was observed as early as three days after dosing and was similar in magnitude and timing to improvements previously seen with bamlanivimab monotherapy. The rate of COVID-related hospitalisation and ER visits was lower for patients treated with combination therapy (0.9%) versus placebo (5.8%) a relative risk reduction of 84.5% (p = 0.049). This was also similar to observations for bamlanivimab monotherapy. An exploratory analysis showed that the proportion of patients with persistent high viral load at day 7 for combination therapy was lower (3%) versus placebo (20.8%), corresponding to a nominal p value of p < 0.0001 without multiplicity adjustment. No emergent putative resistance variants have been observed in patients treated with combination therapy. Earlier results showed that the prespecified primary endpoint, change from baseline in viral load at day 11, was met at the 2 800 mg dose level, but not the others. The endpoint was met in 1.7% (5/302) of bamlanivimab patients, pooled across dose groups, as compared to 6% (9/150) of placebo patient corresponding to 72% risk reduction in this limited population. Additional analyses of viral data demonstrated that bamlanivimab improved viral clearance at an earlier time point (day 3) and reduced the proportion of patients with persistently high viral load at later time points. Bamlanivimab demonstrated a direct antiviral effect against SARS-CoV-2 [12] [13] [29] [28] .

Results from phase III trial showed that bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. Bamlanivimab 2800 mg and etesevimab 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19 by 70 percent, meeting the primary endpoint of the trial [25] . Results from phase III BLAZE-2 trial receiving bamlanivimab at 8 weeks of follow up, demonstrated significantly lower frequency of symptomatic COVID-2019 (the primary endpoint) when compared with placebo (odds ratio 0.43, p = 0.00021). Bamlanivimab also resulted in reduction in risk of contracting COVID-19 by up to 80% in residents versus placebo (odds ratio 0.20; p = 0.00026). In additional, all key secondary endpoints also reached statistical significance in both the overall and resident populations [23] [24] [22] .

Future Events

Expected Date Event Type Description Updated
30 Nov 2020 Regulatory Status Eli Lilly and Company announces intention to submit request for emergency use authorization (EUA) to US FDA for COVID-2019 infections (Combination therapy) in November 2020 [13] 28 Jan 2021
31 Oct 2020 Trial Update Eli Lilly and Company plans a large open-label pragmatic clinical trial for COVID-2019 infections (Combination therapy, Monotherapy) in October 2020 (700328570) [13] 03 Dec 2020

Development History

Event Date Update Type Comment
09 Feb 2021 Phase Change - Registered Registered for COVID-2019 infections (Combination therapy) in Italy (IV) [9] Updated 11 Feb 2021
09 Feb 2021 Phase Change - Registered Registered for COVID-2019 infections (Combination therapy, In adolescents, In the elderly, In adults) in USA (IV) [9] Updated 11 Feb 2021
09 Feb 2021 Regulatory Status The US FDA authorizes shortened infusion times for bamlanivimab alone and in combination with etesevimab [9] Updated 11 Feb 2021
09 Feb 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Monotherapy) in European Union [10] Updated 09 Feb 2021
04 Feb 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Combination therapy) in European Union [10] Updated 09 Feb 2021
29 Jan 2021 Scientific Update Efficacy data from a phase III trial in COVID-2019 infections released by Eli Lilly and Company [25] Updated 02 Feb 2021
27 Jan 2021 Licensing Status Eli Lilly, Vir Biotechnology and GlaxoSmithKline entered an agreement to evaluate bamlanivimab in combination with sotrovimab for COVID-2019 infections [1] Updated 29 Jan 2021
26 Jan 2021 Scientific Update Updated efficacy and adverse events data from a phase II/III BLAZE-1 trial in COVID-2019 infections released by Junshi Biosciences [12] Updated 28 Jan 2021
22 Jan 2021 Scientific Update Adverse events and efficacy data from a phase III trial in COVID-2019 infections released by AbCellera [24] Updated 25 Jan 2021
21 Jan 2021 Regulatory Status Eli Lilly and Company announces intention to submit request for emergency use authorization (EUA) for COVID-2019 infections (Prevention) [23] Updated 25 Jan 2021
21 Jan 2021 Scientific Update Efficacy data from the phase III BLAZE-2 trial in COVID-2019 infections released by Eli Lilly and Company [23] Updated 25 Jan 2021
08 Jan 2021 Trial Update Eli Lilly and Company and AbCellera Biologics plan the phase II BLAZE-5 trial for mild-to-moderate COVID-2019 infections (In children, In adolescents, In adults, In the elderly) (IV) (NCT04701658) Updated 12 Jan 2021
28 Dec 2020 Trial Update Eli Lilly and Company completes a phase I trial in COVID-2019 infections (In volunteers, In adults) in USA (SC) (NCT04537910) Updated 01 Feb 2021
04 Dec 2020 Licensing Status Eli Lilly and Company and UnitedHealth Group collaborate to diagnose and treat COVID-2019 infection with in-home bamlanivimab treatment in USA [2] Updated 10 Dec 2020
04 Dec 2020 Trial Update Eli Lilly and Company and UnitedHealth Group initiate the UNITED trial for COVID-2019 infections in USA (IV) [2] Updated 10 Dec 2020
02 Dec 2020 Licensing Status Bamlanivimab licensed to the US government for the treatment of COVID-2019 infections [3] Updated 10 Dec 2020
30 Nov 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (Combination therapy, In adolescents, In the elderly, In adults) in USA (IV) [12] Updated 28 Jan 2021
30 Nov 2020 Regulatory Status Eli Lilly and Company files request for emergency use authorization (EUA) for COVID-2019 infections (In Children, In adolescents, In adults, In the elderly, Combination therapy) in USA [12] Updated 28 Jan 2021
20 Nov 2020 Phase Change - Registered Registered (interim authorisation) for COVID-2019 infections (In adolescents, In children, In the elderly, In adults) in Canada (IV, injection) [14] Updated 16 Dec 2020
20 Nov 2020 Regulatory Status Lilly was in discussions with regulators from India, Brazil, Russia and Europe for authorisation of bamlanivimab for COVID-2019 infections before November 2020 [14] Updated 24 Nov 2020
20 Nov 2020 Scientific Update Adverse events data from phase II BLAZE-1 trial in COVID-2019 infections released by Eli Lilly and Company [14] Updated 24 Nov 2020
19 Nov 2020 Trial Update Eli Lilly and company completes an expanded-access programme for COVID-2019 infections in US (NCT04603651) Updated 03 Dec 2020
09 Nov 2020 Phase Change - Registered Registered (emergency use authorisation) for COVID-2019 infections (In adolescents, In children, In the elderly, Monotherapy, In adults) in USA (IV, injection) [11] Updated 16 Dec 2020
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Combination therapy) in Puerto Rico (IV) (NCT04634409) after October 2020 [26] Updated 28 Jan 2021
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Monotherapy) in Puerto Rico (IV) (NCT04634409) after October 2020 [26] Updated 28 Jan 2021
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Combination therapy) in USA (IV, infusion) (NCT04634409) Updated 03 Dec 2020
29 Oct 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In adults, Monotherapy) in USA (IV, infusion) (NCT04634409) Updated 03 Dec 2020
28 Oct 2020 Regulatory Status Bamlanivimab is part of Operation Warp Speed for COVID-2019 infections [35] Updated 30 Oct 2020
27 Oct 2020 Trial Update Eli Lilly initiates an expanded access programme in COVID-2019 infections in USA (NCT04603651) Updated 30 Oct 2020
14 Oct 2020 Trial Update Eli Lilly and Company suspends enrolment in its ongoing phase III TICO (ACTIV-3) trial in COVID-2019 infections in USA due to DSMB recommendation [19] Updated 19 Oct 2020
08 Oct 2020 Company Involvement Eli Lilly and Company enters into a COVID-19 Therapeutics Accelerator program with Bill & Melinda Gates Foundation for COVID-2019 infections [34] Updated 09 Nov 2020
07 Oct 2020 Regulatory Status Eli Lilly and Company announces intention to submit request for emergency use authorization (EUA) to US FDA for COVID-2019 infections (Combination therapy) in November 2020 [13] Updated 28 Jan 2021
07 Oct 2020 Phase Change - Preregistration Preregistration for COVID-2019 infections (In adolescents, In children, In the elderly, Monotherapy, In adults) in USA (IV, injection) before October 2020 [13] Updated 16 Dec 2020
07 Oct 2020 Trial Update Eli Lilly and Company plans a large open-label pragmatic clinical trial for COVID-2019 infections (Combination therapy, Monotherapy) in October 2020 [13] Updated 03 Dec 2020
07 Oct 2020 Regulatory Status Eli Lilly and Company announces intention to submit biologics license application (BLA) to US FDA for COVID-2019 infections (Combination therapy) [13] Updated 13 Oct 2020
07 Oct 2020 Regulatory Status Eli Lilly and Company files initial request for emergency use authorization (EUA) for COVID-2019 infections in USA before October 2020 [13] Updated 13 Oct 2020
07 Oct 2020 Scientific Update Interim efficacy and adverse events data from a phase II BLAZE-1 trial in COVID-2019 infections released by Eli Lilly and Company [13] Updated 13 Oct 2020
16 Sep 2020 Scientific Update Interim safety and efficacy data from the phase II BLAZE-1 trial in COVID-2019 infections released by Eli Lilly and Company [29] Updated 18 Sep 2020
16 Sep 2020 Trial Update Eli Lilly and Company completes enrolment in its phase I trial for COVID-2019 infections in USA (IV, injection) (NCT04411628) [29] Updated 18 Sep 2020
07 Sep 2020 Trial Update Eli Lilly and Company plans a phase I pharmacokinetics trial (In volunteers) in USA (NCT04537910) Updated 07 Sep 2020
02 Sep 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (In volunteers, In adults) in USA (SC) (NCT04537910) Updated 16 Dec 2020
26 Aug 2020 Trial Update Eli Lilly and Company completes a phase I trial for COVID-2019 infections in USA (IV, injection) (NCT04411628) Updated 23 Sep 2020
19 Aug 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (In adults, In the elderly) in USA, Puerto Rico (IV, infusion) (NCT04518410) Updated 16 Dec 2020
10 Aug 2020 Trial Update Eli Lilly and Company initiates enrolment in the BLAZE-2 phase III trial for COVID-2019 infections in USA (NCT04497987) [20] Updated 18 Aug 2020
04 Aug 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Combination therapy, In adults, In the elderly) in USA (IV, infusion) (NCT04501978) Updated 10 Aug 2020
03 Aug 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention) in USA (IV, injection) [21] (NCT04497987) Updated 05 Aug 2020
01 Jul 2020 Licensing Status Sanford Burnham Prebys Medical Discovery Institute enters into an research agreement with Eli Lilly and Company to characterise Lilly’s next-generation anti-SARS-CoV-2 antibodies [6] Updated 07 Jul 2020
17 Jun 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (In the elderly, In adults, In adolescents, In children, Combination therapy) in USA (IV, injection) (NCT04427501) [29] Updated 18 Sep 2020
17 Jun 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In the elderly, In adults, In adolescents, Monotherapy) in USA (IV, injection) (NCT04427501) Updated 25 Jun 2020
01 Jun 2020 Trial Update Eli Lilly and AbCellera plan a phase II trial in COVID-2019 infections (IV) [32] Updated 05 Jun 2020
28 May 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (In adults, In the elderly) in USA (IV, injection) [32] (NCT04411628) Updated 05 Jun 2020
12 Mar 2020 Licensing Status Abcellera and Eli lilly and Company agree co-develop Coronavirus neutralizing antibodies for COVID-19 infections [7] Updated 05 Jun 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in Canada (IV) [7] Updated 05 Jun 2020
12 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (IV) [7] Updated 05 Jun 2020
17 Nov 2019 Trial Update Eli Lilly initiates a phase-II/III trial in COVID-2019 infections (In the elderly, In adults, In adolescents, In children, Combination therapy) in Puerto Rico (IV, injection) (NCT04427501) Updated 25 Jan 2021

References

  1. Lilly, Vir Biotechnology and GSK Announce First Patient Dosed in Expanded BLAZE-4 Trial Evaluating Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19.

    Media Release
  2. Lilly and UnitedHealth Group partner on pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19.

    Media Release
  3. Lilly announces 650,000 additional doses of neutralizing antibody bamlanivimab (LY-CoV555) purchased by U.S. government to treat COVID-19.

    Media Release
  4. Samsung Biologics announces strategic manufacturing partnership with Lilly to accelerate delivery of COVID-19 antibody treatments.

    Media Release
  5. Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies.

    Media Release
  6. Sanford Burnham Prebys announces research agreement with Lilly for COVID-19 antibody research.

    Media Release
  7. AbCellera and Lilly to Co-develop Antibody Therapies for the Treatment of COVID-19.

    Media Release
  8. AbCellera Announces Multi-Year Antibody Discovery Collaboration with Lilly.

    Media Release
  9. Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19.

    Media Release
  10. EMA reviewing data on monoclonal antibody use for COVID-19 .

    Media Release
  11. AbCellera-Discovered Antibody Receives U.S. FDA Emergency Use Authorization as a Monotherapy for the Treatment of COVID-19.

    Media Release
  12. New data show treatment with etesevimab (JS016) and bamlanivimab together reduced risk of COVID-19 hospitalizations and death by 70 percent.

    Media Release
  13. Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs.

    Media Release
  14. Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives interim authorization from Health Canada as a treatment for COVID-19.

    Media Release
  15. At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19

    ctiprofile
  16. Expanded Access Information for Physicians for Bamlanivimab (LY3819253) Emergency Investigational New Drug [EIND]

    ctiprofile
  17. Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)

    ctiprofile
  18. A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19

    ctiprofile
  19. Lilly Statement on the NIAID Decision to Pause Enrollment in ACTIV-3 Clinical Trial.

    Media Release
  20. Clinical trials of monoclonal antibodies to prevent COVID-19 now enrolling.

    Media Release
  21. AbCellera Provides COVID-19 Program Update with the Start of Phase 3 Clinical Trials and the Expansion of its COVID-19 Antibody Database.

    Media Release
  22. A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study

    ctiprofile
  23. Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents.

    Media Release
  24. AbCellera-Discovered Antibody Prevented COVID-19 in Nursing Homes and Reduced Risks by up to 80% for Residents.

    Media Release
  25. Lilly Reports Strong Fourth-Quarter and Full-Year 2020 Financial Results.

    Media Release
  26. New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 percent.

    Media Release
  27. A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)

    ctiprofile
  28. A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness

    ctiprofile
  29. Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting.

    Media Release
  30. A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19

    ctiprofile
  31. Lilly Reports Second-Quarter Financial Results, Raises EPS Guidance.

    Media Release
  32. Lilly Begins World's First Study of a Potential COVID-19 Antibody Treatment in Humans.

    Media Release
  33. A Randomized, Placebo-Controlled, Participant- and Investigator-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of LY3819253 Administered Subcutaneously to Healthy Participants

    ctiprofile
  34. Lilly Announces Arrangement for Supply of Potential COVID-19 Antibody Therapy for Low- and Middle-Income Countries.

    Media Release
  35. Lilly announces agreement with U.S. government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19.

    Media Release
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