In August, the FDA said early data suggested KP.3.1.1 might have substantially reduced susceptibility to Pemgarda. At the time, the variant accounted for 36.8% of COVID-19 infections.
A month later, with KP.3.1.1’s dominance at 52.7%, the FDA confirmed Sept. 26 in an email alert that the drug “is likely to retain adequate neutralization activity.”
Pemgarda (pemivibart) is authorized for the pre-exposure prophylaxis of COVID-19 in some adults and children older than 12. Eligible patients are those who have a moderate to severe immune compromise and are unlikely to have an adequate response to a COVID-19 vaccine.
The agency said it will continue to provide updates on Pemgarda’s efficacy against circulating variants.
