RegulatoryJul 6, 2026, 07:02 AM
Invivyd's PEMGARDA EUA to Terminate June 29, 2027
AI Summary
Invivyd, Inc. announced that the FDA issued a Notice of Termination for its PEMGARDA Emergency Use Authorization (EUA), effective June 29, 2027. This follows the U.S. Department of Health and Human Services' broader termination of the COVID-19 EUA declaration. PEMGARDA, authorized since March 2024 for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals, will have a twelve-month transition period. Invivyd plans to pursue a Biologics License Application (BLA) for permanent approval, expressing confidence in its clinical data and ongoing dialogue with the FDA.
Key Highlights
- FDA issued Notice of Termination for PEMGARDA Emergency Use Authorization (EUA).
- PEMGARDA EUA termination is effective June 29, 2027, after a twelve-month transition period.
- HHS announced termination of the COVID-19 EUA declaration on June 30, 2026, effective June 29, 2027.
- PEMGARDA was authorized under EUA since March 2024 for COVID-19 pre-exposure prophylaxis.
- Invivyd intends to pursue a Biologics License Application (BLA) for permanent PEMGARDA approval.
- Company believes PEMGARDA has sufficient clinical and post-authorization data for BLA submission.
- Invivyd is in active dialogue with FDA regarding appropriate next steps for PEMGARDA.
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