After hinting COVID-19 drug Pemgarda might not work against new strains, the FDA announced the medication is effective against KP.3.1.1, the dominant variant.
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.