Invivyd announces FDA authorizes emergency use of Pemgarda for COVID PrEP

Invivyd announced that Pemgarda, formerly VYD222, a half-life extended monoclonal antibody, has received emergency use authorization, or EUA, from the U.S. Food and Drug Administration for the pre-exposure prophylaxis, or PrEP, of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. “The Pemgarda EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S. This EUA milestone represents strategic proof-of-concept for our company and platform, affirming the unique strategy we embarked on over a year ago: to use rapid innovation and surrogate markers to bring new antibodies to market repeatedly. Pemgarda is the first authorized monoclonal antibody from our proprietary platform approach. We are committed to ongoing process improvement while working with global regulatory agencies with the aim to increase the speed and efficiency of new mAb candidate development even further. Additionally, we are planning to explore the protective clinical benefits of mAb prophylaxis for symptomatic COVID-19 disease in future studies,” said Dave Hering, Chief Executive Officer of Invivyd.