AbCellera announced that bebtelovimab (LY-CoV1404), the second antibody developed through AbCellera’s collaboration with Eli Lilly and Company (Lilly), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Bebtelovimab is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The authorized dosage of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.
“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,” said Carl Hansen, Ph.D., CEO of AbCellera. “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. The discovery of two authorized therapeutic antibodies within a year of each other demonstrates the power of our platform, and its potential to quickly generate best-in-class therapeutics for our partners.”
As previously announced, Lilly entered into a purchase agreement with the U.S. government to supply up to 600,000 doses of bebtelovimab no later than March 31, 2022, with an option of 500,000 additional doses no later than July 31, 2022.
Pseudovirus and authentic virus testing confirm bebtelovimab neutralizes Omicron – currently the predominant variant in the U.S. In addition, pseudovirus testing with bebtelovimab demonstrates that it retains neutralization against all other known variants of interest and concern, including BA.2. Previously reported data show bebtelovimab is highly potent and binds to a rarely mutated region of the SARS-CoV-2 spike protein (Westendorf et al, biorxiv, updated January 7, 2022). Further details about the data supporting this EUA and bebtelovimab authorized use and safety information are available here.