Regeneron Receives Expanded Authorized Use from FDA for Antibody COVID-19 Treatment

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

On July 30, 2021, Regeneron Pharmaceuticals announced that FDA updated the Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab), the company’s investigational COVID-19 antibody cocktail. With the expanded authorization, REGEN-COV can now be used as post-exposure prophylaxis in people who are not fully vaccinated or who are not expected to have a good enough response to vaccination. It can also be used for those who are at high risk of progression to severe COVID-19 because they are exposed to, or are at high risk of being exposed to, an infected individual in an institutional setting (e.g., nursing homes or prisons).

In addition, REGEN-COV can now also be administered monthly to those who require repeat dosing for ongoing exposure. The new indication, which is for people aged 12 and older, is in addition to the previously granted authorization to treat non-hospitalized patients. The antibody cocktail is not a substitute for vaccination against COVID-19. It is also not authorized for use as a pre-exposure prophylaxis for preventing COVID-19, Regeneron indicated in a company press release.

Regeneron is working with Roche to increase global supply of the antibody cocktail. Roche is primarily responsible for development and distribution outside the United States. REGEN-COV has not been approved by FDA.

"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, president and chief scientific officer, Regeneron, in the press release. "With this authorization, [FDA] specifically highlights the needs of immunocompromised people, including those taking immunosuppressive medicines who may not mount an adequate response to vaccination and 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 [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."

Source: Regeneron Pharmaceuticals