FDA Updates Pemgarda EUA Due to Emerging SARS-CoV-2 Variants
Key Insights
The FDA has revised the Emergency Use Authorization for Pemgarda, limiting its use to situations where variants with reduced susceptibility are 90% or less of circulating strains.
This decision follows data indicating some SARS-CoV-2 (search) variants, like KP.3.1.1, may exhibit substantially reduced susceptibility to Pemgarda.
Healthcare providers are advised to monitor for COVID-19 (search) symptoms in Pemgarda recipients and promptly initiate alternative treatments if infection occurs.
The U.S. Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) for Pemgarda (pemivibart) to restrict its use based on the prevalence of SARS-CoV-2 (search) variants exhibiting reduced susceptibility to the drug. This decision, announced August 26, 2024, aims to ensure Pemgarda is used when it is most likely to be effective against circulating viral strains.
The revised EUA stipulates that Pemgarda should only be used when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%. This proactive measure is based on ongoing monitoring of variant susceptibility and national variant frequencies.
Impact of Emerging Variants
The FDA's decision was influenced by data suggesting that certain emerging variants of SARS-CoV-2 (search) may have reduced susceptibility to Pemgarda. According to CDC estimates from August 17, 2024, the KP.3 variant comprises approximately 17% of circulating variants in the US, while KP.3.1.1 comprises approximately 37%. While Pemgarda is likely to retain adequate neutralization activity against KP.3, preliminary non-peer reviewed data indicate that KP.3.1.1 may have substantially reduced susceptibility to Pemgarda.
Recommendations for Healthcare Providers
Healthcare providers are now advised to inform patients receiving Pemgarda about the increased risk of developing COVID-19 (search) if exposed to variants with reduced susceptibility. The FDA recommends that patients who develop signs or symptoms of COVID-19 should be tested for SARS-CoV-2 (search) infection and promptly seek medical attention, including starting treatment for COVID-19 if they test positive.
Alternative Treatment Options
The FDA has highlighted that several alternative treatments remain effective against currently circulating variants. These include Paxlovid (nirmatrelvir and ritonavir), Veklury (remdesivir), and Lagevrio (molnupiravir), all of which are approved or authorized for treating certain patients with mild-to-moderate COVID-19 (search) who are at high risk for progression to severe disease, including hospitalization or death. Healthcare providers should assess whether these treatments are appropriate for their patients.