U.S. FDA Authorized Monoclonal Antibody for Pre-Exposure Prevention of COVID-19

Invivyd, Inc. today announced that PEMGARDA™ (pemivibart, VYD222), a half-life extended monoclonal antibody (mAb), has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the pre-exposure prevention 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.

PEMGARDA recipients should not be infected with or have had a known recent exposure to an individual infected with the SARS-CoV-2 coronavirus.

VYD222 was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for preventing and treating COVID-19. 

Dave Hering, CEO of Invivyd, commented in a press release on March 22, 2024, "PEMGARDA is the first authorized mAb from our proprietary platform approach. We are committed to ongoing process improvement while working with global regulatory agencies to increase the speed and efficiency of new mAb candidate development even further."

"Additionally, we plan to explore the protective clinical benefits of mAb prophylaxis for symptomatic COVID-19 disease in future studies."

As previously disclosed in December 2023, a potential early signal of clinical protection from symptomatic COVID-19 confirmed by RT-PCR was observed. Invivyd is now providing an update on the clinical cases of confirmed symptomatic COVID-19 through Day 90.

Beyond today's update, additional cases of COVID-19 have occurred in Cohorts A and B post-Day 90. These data are planned to be analyzed at Day 180 and presented when available.

The FDA says SARS-COV-2-targeting mAbs are laboratory-produced antibodies that can help the immune system attack SARS-COV-2.

These mAbs block entry of SARS-CoV-2 into human cells, thus neutralizing the virus. SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains.

Some virus variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19.