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]  . 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 company intends to submit a subsequent request for EUA for bamlanivimab and etesevimab [see Adis Insight Drug profile 800053492] combination therapy, once additional safety data avanilability, pending clinical trial enrolment and sufficient supply is manufactured. The company also plans to file a biologics license application (BLA) submission for combination therapy  .
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]  .
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  .
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   .
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)  .
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  .
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  . In October 2020, Independent data safety monitoring board (DSMB) recommended to pause enrolment in its ongoing phase III trial  .
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    .
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 enroll 500 patients in the US and planned to expand in Puerto Rico  .
In October 2020, the phase II BLAZE-1 trial met the primary endpoint of the study by significantly reducing viral load at day 11 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 800053492]. The randomised, double-blind, placebo-controlled trial intends to enrol approximately 800 patients in the US  . In September 2020, interim safety and efficacy results from the trial were released by the company  . In October 2020, the company released the interim analysis of the trial  .
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  . 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    .
In September 2020, Eli Lilly and Company initiated a phase I trial to evaluate the pharmacokinetics, safety, and tolerability of bamlanivimab, administered subcutaneously in healthy volunteers (NCT04537910; 18124; J2X-MC-PYAG). The randomised, placebo-controlled, double-blind study intends to enrol approximately 27 participants in the US  .
As of March 2020, early research development for COVID-2019 treatment is underway in Canada  .
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  .
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  .