The Food and Drug Administration (FDA) has authorized a monoclonal antibody cocktail as a measure to prevent infection in some groups of people who were exposed to the CCP virus, the pathogen that causes COVID-19.
The FDA on Friday announced that it had revised its emergency use authorization (EUA) for REGEN-COV, a treatment consisting of jointly administered casirivimab and imdevimab, expanding its use beyond just the treatment of patients who test positive for the virus.
While the product remains authorized for treating confirmed COVID-19 patients over age 12 who are at high risk of severe illness, the agency said the drug combo can now be given to high-risk groups as a measure after exposure to prevent progression of the disease.
The antibody treatment is only authorized for use in people who have been exposed to the CCP (Chinese Communist Party) virus, not as a pre-exposure preventive measure, the FDA said.
The agency added that REGEN-COV should only be used as a post-exposure prophylaxis by people who are not fully vaccinated or whose immune systems are unlikely to mount an adequate response to the virus, like those who take immunosuppressive medications or who are otherwise immunocompromised.
“Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19,” the FDA noted, while urging people to get the shot.
The FDA said the primary data driving the expansion of the emergency use authorization for REGEN-COV were based on a Phase 3 clinical trial that was randomized, double-blind, and placebo-controlled. The trial found an 81 percent reduction in confirmed symptomatic COVID-19 cases in people testing negative at the start of the study and who had household contact with people who were infected with the virus.
Dr. Myron Cohen, a researcher at the University of North Carolina at Chapel Hill and one of the investigators behind the study of COVID-19 antibodies, told NBC that the REGEN-COV drug cocktail works by overwhelming the infection while it is still in its early stages.
“It’s a race between your ability to make an antibody to protect your lungs and the rest of your body and the virus,” Cohen told the outlet. “And if you’re likely to lose the race, you’re the person for whom these antibody drugs are appropriate.”
BY TOM OZIMEK