The FDA issued Emergency Use Authorization (EUA) for Pemgarda (pemivibart) as a pre-exposure prophylaxis (PrEP) against COVID-19, according to manufacturer Invivyd Inc.

RT’s Three Key Takeaways:

  1. EUA Approval for Pemgarda: Pemgarda has received EUA for PrEP of COVID-19 in adults and adolescents with moderate to severe immune compromise, providing a crucial preventive option for vulnerable populations.
  2. Novel Trial Design: Pemgarda is the first PrEP monoclonal antibody (mAb) authorized by the FDA based on a novel, rapid, and repeatable immunobridging trial design, demonstrating Invivyd’s commitment to innovative solutions.
  3. Protective Mechanism: The bcl3 gene limits lung damage during acute stress, offering potential protection against COVID-19-related complications. Pemgarda’s authorization signifies a breakthrough in addressing the urgent need for effective preventive measures.

Expert Perspectives:

  • Dr. Dave Hering, CEO of Invivyd: Emphasizes the strategic significance of the Pemgarda EUA and highlights the company’s dedication to rapid innovation in antibody therapies.
  • Dr. Cameron R. Wolfe, Duke University School of Medicine: Recognizes the importance of Pemgarda as an additional preventive option for immunocompromised patients, contributing to efforts to mitigate COVID-19 risks.
  • Jorey Berry, Immune Deficiency Foundation: Welcomes the availability of Pemgarda as a critical tool in protecting vulnerable populations from COVID-19.

Understanding Pemgarda and its Impact:

  • Mechanism of Action: Pemgarda targets conserved epitopes of SARS-CoV-2, offering durable protection against evolving viral variants.
  • Administration: Administered via intravenous infusion, Pemgarda presents a convenient and effective option for COVID-19 PrEP.
  • Platform Innovation: Developed using Invivyd’s Invymab platform, Pemgarda represents a paradigm shift in antibody therapy development, ensuring continuous access to innovative treatments.