FDA Rejects Invivyd's Expansion Bid for COVID-19 Antibody Treatment

Invivyd, Inc. (IVVD) suffered a significant setback on Monday, February 24, 2025, as the U.S. Food and Drug Administration (FDA) declined the company's request to expand the emergency use authorization (EUA) for its monoclonal antibody medication, Pemgarda (pemivibart), to treat mild-to-moderate COVID-19 in immunocompromised patients. The existing EUA for pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised patients remains in effect.

The FDA's decision centered on the requirement that COVID-19 treatment immunobridging analyses for monoclonal antibodies (mAbs) must demonstrate superior antiviral activity, rather than equivalent antiviral activity, compared to previously authorized and now inactive COVID-19 mAbs. Invivyd's submission showed comparable antiviral activity between pemivibart and adintrevimab, the key antibody of interest for immunobridging, as well as predicted clinical efficacy in-line with prior authorized mAb therapeutics and well above currently authorized convalescent plasma.



Invivyd plans to share detailed data and regulatory correspondence regarding pemivibart, VYD2311, and immunobridging of COVID-19 antibodies in the near term, allowing Americans to better appreciate the historic and recent governmental handling of these assets in contrast to COVID-19 vaccines and small molecule treatments. The company also plans to rapidly advance VYD2311 in collaboration with the FDA, given the ongoing and unacceptable burden of COVID-19 in America, including high rates of death, hospitalization, and Long COVID.

The COVID-19 treatment opportunity for pemivibart was not contemplated in existing financial guidance, and the lost treatment indication significantly constrains PEMGARDA's market potential. While the existing prophylaxis EUA remains valuable, treatment authorization would have substantially expanded the addressable patient population and revenue opportunities. The FDA's stance suggests a more stringent approach to COVID-19 therapeutics, potentially affecting other companies developing similar treatments and reshaping development strategies across the industry.

Invivyd's Senior Vice President of Clinical Development, Mark Wingertzahn, commented, "This is a sad day for patients in need. Immunocompromised people who cannot access standard of care are once again left with no option for COVID-19 treatment. Pemivibart is active and in clinical use today in the U.S. as authorized, but it is now being withheld from those same immunocompromised patients fighting active COVID-19 infection purportedly because its measured antiviral activity is in-line with, but does not clearly exceed, the activity of its key comparator antibody adintrevimab, as well as other comparative mAbs."

Dr. Alfred H. Kim, MD, PhD, Associate Professor of Medicine and Pathology and Immunology at Washington University School of Medicine, added, "It is disappointing that healthcare providers are unable to add the power of a mAb therapy for treatment of COVID-19 to our current therapeutic options. We need tools like PEMGARDA immediately to lessen the ongoing, unacceptable burden of COVID-19 death and hospitalization."

In conclusion, the FDA's decision to require superior antiviral activity for COVID-19 treatment monoclonal antibodies sets a new, higher bar for approvals, potentially impacting the future development and approval of similar therapeutics. Invivyd's strategic adaptations, such as sharing detailed data and rapidly advancing VYD2311, could help the company navigate this more stringent regulatory environment and increase the chances of success for its COVID-19 therapeutics.