Regeneron’s Antibody Cocktail Authorized for Preventing COVID-19 in Exposed Patients

The FDA revised its emergency authorization of Regeneron’s antibody cocktail, REGEN-COV (casirivimab/imdevimab), to include its use for prevention of  COVID-19 infection in individuals 12 years and older who have been exposed to the coronavirus and are at high risk of progressing to severe disease.

The agency originally granted Emergency Use Authorization (EUA) for the cocktail in November 2020 to treat mild-to-moderate COVID-19 in patients 12 years and older who are at high risk of progressing to severe disease (DID, Nov. 24, 2020).

The agency also revised the EUA last month to reduce its dosage by half the amount originally authorized, from 2,400 mg to 1,200 mg (DID, June 7).

In its latest revision, the FDA emphasized that the antibody cocktail is not a substitute for vaccination and should only be used as a postexposure prophylaxis in those who are not fully vaccinated or who are not expected to have a sufficient immune response to vaccination, such as those who are immunocompromised or taking immunosuppressants. ― Jason Scott