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FDA Releases Important Information About Risk of COVID-19 Due to SARS-CoV-2 Viral Variants with Substantially Reduced Susceptibility to Pemgarda (pemivibart) 

The U.S. Food and Drug Administration today revised the Emergency Use Authorization (EUA) for Pemgarda (pemivibart) to limit its use to when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%.

This revision is based on available information including variant susceptibility to Pemgarda and national variant frequencies. FDA is proactively incorporating this Limitation of Authorized Use in the event that variants with substantially reduced susceptibility to Pemgarda reach this threshold. Pemgarda remains authorized for emergency use for pre-exposure prevention of COVID-19, consistent with its terms and conditions as detailed in the Letter of Authorization, at this time. 

FDA also added important information to the authorized fact sheets to inform health care providers and individuals receiving Pemgarda of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that have substantially reduced susceptibility to Pemgarda. Detailed neutralization data can be found in the revised authorized Fact Sheet for Health Care Providers. Health care providers should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate, if they test positive. 

The most frequently reported SARS-CoV-2 viral variants circulating at this time in the US are KP.3 and KP.3.1.1.  Based on CDC’s Nowcast estimates from August 17, 2024, KP.3 comprises approximately 17% of circulating variants in the US and KP.3.1.1 comprises approximately 37% of circulating variants in the US.  Based on the data currently available (see Section 12.4 of the Fact Sheet for Health Care Providers), Pemgarda is likely to retain adequate neutralization activity against KP.3. Preliminary, non-peer reviewed data in the public domain indicate that KP.3.1.1 may have substantially reduced susceptibility to Pemgarda.  The fact sheet will be updated as more data become available.

There are several treatments – Paxlovid (nirmatrelvir and ritonavir), Veklury (remdesivir) and Lagevrio (molnupiravir) – that are expected to work against currently circulating variants, and that are approved or authorized to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether these treatments are right for their patients.  

More information and resources about Pemgarda are available on FDA’s website. 

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