FDA approves Regeneron antibody cocktail for COVID-19 prevention

The FDA revised its emergency use authorization for Regeneron’s COVID-19 antibody cocktail July 30, allowing the treatment to be used as a post-exposure prophylaxis for COVID-19 in individuals who are at high risk for progression to severe COVID-19.

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The treatment, a cocktail of casirivimab and imdevimab, was granted FDA emergency use authorization in November.

When announcing the revision to its emergency approval, the FDA stipulated that the antibody cocktail is authorized as a COVID-19 prophylaxis only for individuals who have been exposed to the virus. The agency also said the treatment is not a substitute for a COVID-19 vaccine.

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