MedPageToday 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