People who are immunocompromised have a new tool to prevent COVID-19. On Friday, the Food and Drug Administration approved Pemgarda, a monoclonal antibody that’s designed to protect immunocompromised individuals over the age of 12 against COVID-19.
The approval is an emergency use authorization (EUA). This means the FDA fast-tracked approval to bring the product on the market quicker.
Pemivibart (Pemgarda) is for immunocompromised individuals, many of which may not receive enough protection from vaccines. The treatment is specifically for cell transplant and organ transplant recipients, and people with blood cancers. Formerly known as VYD222, the medication is given intravenously. It’s not a treatment for COVID-19; like a vaccine, it’s meant to prevent people from getting the virus that causes COVID-19.
“This is an important development for the 6.6% of Americans who are immunocompromised — offering the hope of a safer future to those among us who are still most at risk from COVID,” Matthew Cortland, a senior fellow at Data for Progress, said in an article on STAT.
The EUA approval came from a phase 3 study including about 750 people.
“People who are immunocompromised continue to be disproportionally impacted by COVID-19 even after receiving multiple vaccine doses,” Cameron R. Wolfe, MPH, a professor of Medicine, Transplant Infectious Disease at Duke University School of Medicine, said in a statement. “I’m excited to have Pemgarda as an additional COVID-19 preventive option for moderately to severely immunocompromised adult and adolescent patients, such as solid organ transplant recipients and those with hematological malignancies. These types of patients, among others, continue to have both an impaired response to vaccines and a higher risk for severe COVID-19 outcomes.”
The medicine is the first monoclonal antibody made by Invivyd that’s been approved by the FDA.
