FDA authorizes Regeneron antibody cocktail for post-exposure prophylaxis of COVID-19
Following the June update that allowed for a lower dose of Regeneron’s antibody cocktail to treat COVID-19, the FDA has again expanded emergency use authorization, this time allowing for its use as post-exposure prophylaxis.
According to a press release from Regeneron, the update enables individuals who have already been exposed to SARS-CoV-2, along with those who are at high risk of being exposed due to residing in an institutional setting (eg, nursing homes or prisons), to receive the cocktail.
"Today's FDA authorization enables certain people at high risk of developing severe COVID-19 infection to access REGEN-COV if they have been exposed to the virus — the first time an antibody treatment has been authorized for this purpose," George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in the release. "With this authorization, the FDA specifically highlights the needs of immunocompromised people, including those taking immunosuppressive medicines, who may not mount an adequate response to vaccination, who are exposed to a person with COVID-19 or are in an institutional setting and are at high risk of exposure because of infection occurring in the same setting.”
The release further noted that the cocktail, a combination of casirivimab and imdevimab known as REGEN-COV, can now also be administered monthly for individuals 12 years of age and older who require repeat dosing for ongoing exposure.
REGEN-COV is not intended to be used as a substitute for vaccination against COVID-19 and is not authorized for pre-exposure prophylaxis to prevent COVID-19, according to the release.
“Today's FDA decision to expand the use of REGEN-COV in post-exposure settings is a very helpful step, and we continue to work with the FDA as it undertakes its review of REGEN-COV in a broader group of people including in a pre-exposure prophylactic setting for people who are immunocompromised, and in patients hospitalized due to COVID-19,” Yancopoulos said.