By Katherine Kahn
Source Medpagetoday
The FDA has determined that the monoclonal antibody pemivibart (Pemgarda) is likely to be effective against currently circulating SARS-CoV-2 variants, including KP.3.1.1 and LB.1.
“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.,” the agency said in a press releaseopens in a new tab or window.
This is welcome news for patients at risk for severe COVID-19, such as those with immunocompromising conditions. Pemivibart remains the only available monoclonal antibodyopens in a new tab or window for the prevention of COVID-19 in this population.
In late August, the FDA had revised the emergency use authorization (EUA) for pemivibart, adding a limitation of authorized useopens in a new tab or window over concerns that KP.3.1.1 may have had substantially reduced susceptibility to the drug. The FDA indicated that pemivibart should only be used for pre-exposure prophylaxis of COVID-19 in immunocompromised patients when the combined national frequency of SARS-CoV-2 variants with substantially reduced susceptibility to the drug is less than or equal to 90%.
Read more https://www.medpagetoday.com/infectiousdisease/covid19/112152