Invivyd announces NEJM published letter to editor on PEMGARDA

Invivyd (IVVD) announces that The New England Journal of Medicine, NEJM, has published a peer-reviewed Letter to the Editor describing the PEMGARDA immunobridging emergency use authorization pathway, as well as an updated correlate of protection curve for prevention of symptomatic COVID-19 via recombinant monoclonal antibodies such as pemivibart. The immunobridging approach highlighted in NEJM draws on pharmacokinetic bioequivalence principles and was designed by the U.S. Food and Drug Administration to allow rapid development and authorization of serial, novel mAbs that can protect vulnerable populations from symptomatic COVID-19 amid a rapidly evolving variant landscape. The immunobridging approach established by the FDA for pemivibart development relied on a comparison between the serum virus neutralizing antibody titers of a novel antibody, pemivibart, and the sVNA titer associated with previous clinical protection at a single point in time from a single prototype mAb, in this case, Invivyd’s prior investigational mAb, adintrevimab.