Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
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Eli Lilly‘s proposed antibody drug bebtelovimab has received emergency use authorization (EUA) from the U.S. Food and Drug Administration after demonstrating its potency against SARS-CoV-2’s Omicron variant.
The EUA was expected and comes just a day after the U.S. government signed a deal for the company to supply it with 600,000 doses of the investigational treatment bebtelovimab for a minimum of $720 million by March 31, 2022.
The government agreement was conditional on the EUA, and now that the FDA has given its green light, there’s a possibility of a further 500,000-dose order by July 31, 2022. The order is supported by funds from the Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, and Biomedical Advanced Research and Development Authority.
Bebtelovimab is a neutralizing IgG1 monoclonal antibody (mAb) that works directly against the SARS-CoV-2 spike protein seen in known virus variants, including BA.2 and Omicron. It is indicated for mild-to-moderate COVID-19 in adults and pediatric patients aged 12 years and up who are at risk for progression to severe COVID-19. It is administered as a 175 mg intravenous injection and may be used by itself or in combination with other mAbs.
Eli Lilly obtained the license to develop the drug after AbCellera and researchers at the National Institute of Allergy and Infectious Diseases discovered it in 2020.
“Early in 2021, prior to the identification of the Omicron variant, Lilly scientists were already working to develop bebtelovimab as a broadly neutralizing antibody that could be used to fight a highly mutated variant, should one emerge. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic,” said Daniel Skovronsky, M.D., Ph.D., the chief scientific and medical officer at Lilly and president of Lilly Research Laboratories, in a statement.
The FDA’s EUA decision was based on positive results from the Phase II BLAZE-4 trial, which evaluated bebtelovimab alone or in combination with 700mg of bamlanivimab and 1,400mg of etesevimab. Tests showed that the drug is able to fully neutralize Omicron and BA.2 activity.
“At the start of the COVID-19 pandemic we and our partners prioritized speed in getting therapies out to patients. This resulted in the discovery of bamlanivimab, the first COVID-19 antibody to reach the clinic and receive FDA Emergency Use Authorization. We then shifted our efforts to discovering a next-generation antibody therapeutic, this time prioritizing maximum potency and breadth of neutralization. This resulted in the discovery of bebtelovimab, which neutralizes all known variants of concern, and is the most potent antibody in development against the Omicron variant, including BA.2,” said Carl Hansen, Ph.D. the chief executive officer of AbCellera, in a separate statement.
Bebtelovimab and bamlanivimab were created using antibodies discovered using AbCellera’s pandemic response platform. As its partner, Lilly is taking care of both drugs’ development, manufacturing and distribution.
The emergency use of bebtelovimab is only for the duration of the declaration under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) and can be terminated or revoked as the FDA sees fit.
