Invivyd announces FDA update on Pemgarda fact sheet for SARS-CoV-2 variants

Invivyd announced that the FDA has re-issued an updated Emergency Use Authorization – EUA – Fact Sheet for Healthcare Providers for Pemgarda to provide accurate in vitro neutralization activity of Pemgarda against dominant circulating variants including KP.3.1.1 and LB.1. The FDA’s newly updated Fact Sheet, dated September 26, removes a contested statement that “preliminary, non-peer-reviewed data in the public domain indicate that KP.3.1.1 may have substantially reduced susceptibility to pemivibart.” The FDA has now included viral neutralization data for pemivibart that is in line with prior variants represented in the CANOPY Phase 3 clinical trial and determined that Pemgarda is likely to retain adequate neutralization activity against SARS-CoV-2 variants currently circulating in the U.S., including KP.3.1.1. Invivyd relies on extensive structural analysis to understand the stability of the pemivibart binding site and uses neutralization bioassays to assess the possible influence of epistasis and allostery. The company will continue to assess variant susceptibility in partnership with the FDA.