BRIEF—FDA approves REGEN-COV for post-exposure prophylaxis for COVID-19

The US Food and Drug Administration has updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV (casirivimab and imdevimab).

REGEN-COV has been developed by USA-based Regeneron Pharmaceuticals and Swiss pharma giant Roche.

The authorization now includes post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).

REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus -- only after exposure to the virus.

REGEN-COV should only be used as post-exposure prophylaxis for  specific patient populations. Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19, the FDA noted.