Regeneron Pharma: FDA To Review BLA For REGEN-COV Antibody Cocktail To Treat COVID-19

Regeneron Pharmaceuticals, Inc. (REGN) said the FDA has accepted for priority review a Biologics License Application for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The FDA has assigned a target action date of April 13, 2022. REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using the company's VelocImmune and VelociSuite technologies.

REGEN-COV is an investigational medicine and has emergency or temporary pandemic authorizations in more than?40?countries, including the U.S. It is fully approved in Japan and conditionally approved in the UK. Earlier in the week, the European Medicines Agency accepted for review the Marketing Authorization Application for the same antibody cocktail, known as Ronapreve in the EU.

Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply.

Shares of Regeneron Pharmaceuticals were up 2% in pre-market trade on Thursday.

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