TARRYTOWN, N.Y., July 30, 2021 /PRNewswire/ —
Expanded authorization enables use of REGEN-COV for post-exposure prophylaxis in certain people exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual in an institutional setting
Supported by pivotal Phase 3 data showing 81% reduced risk of symptomatic infections in close contacts of SARS-CoV-2 infected individuals
Only COVID-19 antibody therapy currently available across the U.S. for both treatment and post-exposure prophylaxis; REGEN-COV retains potency against variants of concern
Use of REGEN-COV across the U.S. is rapidly increasing to address ongoing outbreaks
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV™ (casirivimab and imdevimab). 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).
In those who require repeat dosing for ongoing exposure, REGEN-COV can also now be administered monthly. This new indication in people aged 12 and older is in addition to the previously granted authorization to treat non-hospitalized patients. REGEN-COV is not a substitute for vaccination against COVID-19, and is not authorized for pre-exposure prophylaxis to prevent COVID-19.
“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,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “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. 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.”Read Full Release