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FDA updates Pemgarda’s SARS-CoV-2 variant susceptibility data

The U.S. Food and Drug Administration today revised the Fact Sheet for Health Care Providers with new SARS-CoV-2 variant susceptibility data for Pemgarda (pemivibart), including data on variants KP.3.1.1 and LB.1.

The most frequently reported SARS-CoV-2 viral variant at this time in the U.S. is KP.3.1.1. Based on CDC’s Nowcast estimates from September 14, 2024, KP.3.1.1 comprises approximately 53% of circulating variants in the U.S.

FDA previously reported that preliminary, non-peer-reviewed data in the public domain indicated that KP.3.1.1 may have substantially reduced susceptibility to Pemgarda. Based on additional data now available, FDA has determined that Pemgarda is likely to retain adequate neutralization activity against KP.3.1.1 (see Section 12.4 of the Fact Sheet for Health Care Providers and the FDA memo dated September 25, 2024). This means it may be effective for pre-exposure prophylaxis of COVID-19 caused by this variant. Based on current CDC Nowcast estimates and variant spike receptor binding domain similarity to tested variants, FDA anticipates Pemgarda will retain activity against the currently circulating variants in the U.S. 

FDA will continue to provide updates on variant susceptibility to assist prescribers and patients who utilize Pemgarda for pre-exposure prevention of COVID-19. More information and resources about Pemgarda are available on FDA’s website.

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