U.S. FDA OKs Regeneron COVID-19 antibody as preventive in high-risk settings
The U.S. Food and Drug Administration has expanded the emergency use authorization of Regeneron Pharmaceuticals Inc's COVID-19 antibody cocktail, enabling its use as a preventive treatment for the illness in certain people.
The company said the authorization enables the therapy to be used in people exposed to an infected individual, or who are at high risk of exposure to an infected individual in settings such as nursing homes or prisons.
The combo therapy, REGEN-COV, was authorized in November for emergency use to treat people with mild-to-moderate COVID-19 in the United States.
REGEN-COV, a combination of casirivimab and imdevimab, protected household contacts from exposure to SARS-CoV-2, with 72% protection against symptomatic infections in the first week, and 93% after that, according to trial data released by the company in April.
Regeneron said the expanded authorization will help address the needs of immunocompromised people, including those taking immunosuppressive medicines, whose bodies may not mount an adequate response to COVID-19 vaccination.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Devika Syamnath)