FDA Revokes Emergency Use Authorization for Bebtelovimab Due to Expired Lots and Variant Resistance

Key Insights

• The FDA revoked the Emergency Use Authorization (EUA) for bebtelovimab on December 5, 2024, following a request from Lilly due to the expiration of all manufactured lots.
• Bebtelovimab was no longer authorized for use in regions where SARS-CoV-2 variants demonstrated resistance, based on available susceptibility data and variant frequency.
• The FDA determined that revoking the EUA was necessary to protect public health, given the reduced efficacy against circulating variants and the expiration of existing supplies.

The U.S. Food and Drug Administration (FDA) has revoked the Emergency Use Authorization (EUA) for bebtelovimab, a monoclonal antibody previously authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients. The decision, announced on December 13, 2024, follows a request from Eli Lilly and Company, the manufacturer of bebtelovimab.

Lilly's request stemmed from the expiration of all bebtelovimab lots manufactured and labeled under EUA 111. Furthermore, the drug was no longer authorized for use in geographic regions of the United States where infection was likely caused by non-susceptible SARS-CoV-2 variants. This determination was based on available information, including variant susceptibility to bebtelovimab and regional variant frequency.

The FDA concluded that revoking the EUA was appropriate to protect public health and safety. The agency's decision reflects concerns about the drug's effectiveness against emerging variants and the practical limitations of using expired medication.