FDA Could Soon Limit Use of Only Drug for COVID Prevention

MedPage Today August 27, 2024
Katherine Kahn

— Pemivibart may have reduced activity against growing variant KP.3.1.1, agency warns

Pemivibart (Pemgarda) should only be used for pre-exposure prophylaxis of COVID-19 in immunocompromised patients when the combined national frequency of SARS-CoV-2 variants with substantially reduced susceptibility to the drug is less than or equal to 90%, the FDA announced on Monday.

The agency revised the emergency use authorization (EUA) for the long-acting monoclonal antibody based on available information about SARS-CoV-2 variant susceptibility to pemivibart and national variant frequency, Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, wrote in a letter to pemivibart’s manufacturer, Invivyd.

“FDA is proactively incorporating this Limitation of Authorized Use in the event that variants with substantially reduced susceptibility to...

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