Bebtelovimab FDA Approval Status
Last updated by Judith Stewart, BPharm on Dec 16, 2024.
FDA Approved: No (Discontinued)
Generic name: bebtelovimab
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: COVID-19
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 December 5, 2024, Lilly requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for bebtelovimab since all lots of bebtelovimab manufactured and labeled for use under EUA 111 have expired. At the time of Lilly’s request, bebtelovimab was not authorized for use in geographic regions of the United States where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to bebtelovimab and regional variant frequency. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.
- 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
Further information
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