Bebtelovimab FDA Approval Status
Bebtelovimab is an investigational human immunoglobulin G-1 (IgG1 variant) monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 for the treatment of COVID-19.
- On February 11, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for bebtelovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients who are at high risk for progression to severe COVID-19. Bebtelovimab demonstrated binding and neutralizing activity across the variants of concern at that time, including Omicron and BA.2.
- On November 30, 2022, the FDA announced the withdrawal of the Emergency Use Authorization for bebtelovimab for the treatment of COVID-19 because it is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1.
Development timeline for bebtelovimab
|Nov 30, 2022
|FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region
|Feb 11, 2022
|Lilly's Bebtelovimab Receives Emergency Use Authorization for the Treatment of Mild-to-Moderate COVID-19
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