Benzinga | Oct 14, 2021 07:23AM EDT

Regeneron Pharmaceuticals Announces FDA Accepts REGEN-COV For Priority Review For Treatment And Prophylaxis Of COVID-19

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for REGEN-COV(r) (casirivimab and imdevimab) 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 and informed us that they currently are planning to hold an advisory committee meeting to discuss this application in advance of that date.

The BLA is supported by two positive Phase 3 trials involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts). A second BLA submission focusing on the treatment of patients hospitalized due to COVID-19 is expected to be submitted later this year.

Regulatory submissions are also progressing in the European Union (EU). Earlier this week, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for the same antibody cocktail, known as Ronapreve(tm) in the EU and other countries outside of the U.S., for use in certain people either as a treatment in infected non-hospitalized patients, or as prophylaxis. The submission approach for the EMA is similar to that used for the FDA, with a Type II Variation planned in those already hospitalized because of COVID-19.

In the U.S., REGEN-COV has not been approved by the FDA, but is currently authorized under an Emergency Use Authorization (EUA) totreat people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certainpost-exposure prophylaxissettings. REGEN-COV is available for free toeligible people as part of aU.S.government funded program, and in September Regeneron announced a new agreement with the U.S. government to supply an additional 1.4 million 1,200 mg doses of REGEN-COV by January 2022. Information on how to access REGEN-COV throughout the U.S. is available from the Department of Health and Human Services and the National Infusion Center Association.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.