FDA Revokes Emergency Use Authorization for Sotrovimab

Key Insights

• The FDA has revoked the Emergency Use Authorization (EUA) for sotrovimab due to the expiration of all manufactured lots under EUA 100.
• GSK requested the EUA revocation on November 22, 2024, as sotrovimab was not authorized for use against non-susceptible SARS-CoV-2 variants.
• The FDA determined that revoking the authorization is appropriate to protect public health and safety, considering variant susceptibility.

The U.S. Food and Drug Administration (FDA) has revoked the Emergency Use Authorization (EUA) for sotrovimab, a monoclonal antibody previously authorized for the treatment of COVID-19. The decision, effective December 13, 2024, follows a request from GSK on November 22, 2024, to revoke the EUA.

The revocation is based on the fact that all lots of sotrovimab manufactured and labeled for use under EUA 100 have expired. Furthermore, sotrovimab was not authorized for use in regions where infection was likely caused by SARS-CoV-2 variants against which the drug is not susceptible, based on available data regarding variant susceptibility and regional variant frequency.

The FDA has determined that it is appropriate to revoke the authorization to protect public health and safety. This decision reflects the agency's ongoing assessment of available scientific information and the evolving landscape of SARS-CoV-2 variants.