There may soon be a new treatment option for certain immunocompromised individuals diagnosed with COVID-19. Pemivibart or Pemgarda, is already authorized for Pre-Exposure Prophylaxis (PrEP) to prevent infection. Now, Invivyd, the manufacturer, plans to submit an emergency use authorization (EUA) application to the FDA for the use of pemivibart to treat immunocompromised individuals already infected and dealing with mild to moderate symptomatic COVID-19.
Past COVID-19-directed monoclonal antibodies (cMABs) are no longer effective and, therefore, unavailable as the SARS-CoV-2 virus has mutated. Due to its unique target on the virus, this new antibody holds the potential to be a more durable COVID-19 slayer, offering both prevention and treatment options. It does come with the risk of rare but potentially serious side effects, including a severe allergic reaction (anaphylaxis).
For those interested in learning more about this evolving treatment option, we encourage you to read the official press release: Invivyd to Pursue Rapid Immunobridging Pathway to Potential EUA for Treatment of COVID-19 in Moderately to Severely Immunocompromised People, Based on U.S. FDA Feedback. It’s essential to stay informed and understand this new therapy’s potential benefits. The press release explains the accelerated path to a quicker EUA that the FDA and Invivyd are using for this second potential indication.
Stay strong. We are all in this together.
Brian Koffman MDCM (retired) MS Ed (he, him, his)
Co-founder, Executive VP, and Chief Medical Officer
CLL Society, Inc.
