The FDA has recently authorized a new antibody drug, Pemgarda, developed by biotech company Invivyd, to protect immunocompromised individuals from Covid-19. This approval comes after the withdrawal of AstraZeneca’s Evusheld due to its ineffectiveness against Omicron variants. Immunocompromised individuals, such as certain cancer patients, organ transplant recipients, and those with autoimmune disorders, often have weakened immune systems and may not receive sufficient protection from vaccines alone. Pemgarda offers an additional layer of defense against severe Covid-19 for this vulnerable population.
Despite the significant need for such treatments, it remains uncertain how many patients will opt for Pemgarda. Invivyd estimates there are 9 million immunocompromised individuals in the U.S., but the initial focus will be on the 485,000 with the most urgent need. Factors such as vaccine efficacy, booster uptake, and previous Covid-19 exposure influence patient interest in additional protections like Pemgarda.
While the drug could provide peace of mind for individuals like Krista Coombs, who suffers from common variable immune deficiency and has experienced long Covid, concerns about accessibility and affordability remain. Invivyd has not disclosed the drug’s price, but CEO Dave Hering suggested it would likely exceed previous antibody drug costs due to factors such as commercial sale and increased antibody dosage.
Pemgarda represents a re-engineered version of Invivyd’s original antibody, adapted to cover Omicron variants, offering a faster route to market compared to competitors starting from scratch. With the authorization of Pemgarda, there’s hope for a safer future for immunocompromised individuals facing heightened risks from Covid-19.