FDA Expands Regeneron Monoclonal Antibody Cocktail EUA for Post-Exposure Prophylaxis

FDA Expands Regeneron Monoclonal Antibody Cocktail EUA for Post-Exposure Prophylaxis

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGN-COV™ (combination of casirivimab and imdevimab) for what is now the post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or not expected to mount an adequate response to the vaccination, and have been exposed to a SARS-CoV-2 infected induvial, 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). Moreover, for those patients who require repeat dosing for ongoing exposure, REGEN-COV can also now be administered monthly. The new indication in people aged 12 and older is in addition to the previously granted authorization to treat non-hospitalized patients. The company issued in their press release that the product isn’t a substitute for a vaccination against COVID-19 and is not authorized for pre-exposure prophylaxis to prevent COVID-19.

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