Invivyd Faces FDA EUA Termination for PEMGARDA as COVID-19 Emergency Declaration Ends
Event summary
- Invivyd received a Notice of Termination for PEMGARDA's EUA, effective June 29, 2027.
- The termination follows HHS's advanced notice to end the COVID-19 EUA declaration.
- Invivyd is in dialogue with FDA about next steps but has not yet received written advice on a regulatory approval pathway for PEMGARDA.
- PEMGARDA has been used clinically for over two years and demonstrated strong protection against contemporary SARS-CoV-2 variants.
The big picture
The termination of PEMGARDA's EUA reflects the broader shift from emergency measures to permanent regulatory frameworks for COVID-19 therapies. Invivyd's ability to navigate this transition will be critical, as monoclonal antibodies like PEMGARDA remain a vital option for immune-compromised individuals who do not respond adequately to vaccines. The company's dialogue with FDA and its strategy for BLA submission will shape the future of PEMGARDA in the post-EUA landscape.
What we're watching
- Regulatory Pathway Uncertainty
- Whether Invivyd can secure a Biologics License Application (BLA) approval for PEMGARDA given the lack of explicit guidance from FDA.
- Market Access Challenges
- How the transition from EUA to potential BLA approval may impact PEMGARDA's market access and reimbursement status.
- Competitive Landscape
- The pace at which other COVID-19 prevention options, including vaccines and monoclonal antibodies, evolve as the pandemic shifts to an endemic phase.