Regeneron Seeks Full Approval of COVID-19 Treatment

The FDA has assigned a target action date of April 13, 2022, and plans to hold an advisory committee meeting.

The FDA has accepted Regeneron’s application for full approval of REGEN-COV (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. The agency plans to hold an advisory committee meeting to discuss this application in advance of that date.

The biologics license application is supported by two positive phase 3 trials involving more than 6,000 patients in non-hospitalized patients and as prophylaxis. A second BLA submission focusing on the treatment of patients hospitalized due to COVID-19 is expected to be submitted later this year.

REGEN-COV is currently available under an emergency use authorization to treat 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 certain post-exposure prophylaxis settings. REGEN-COV is available for free to eligible people as part of a U.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.

REGEN-COV is a cocktail of two monoclonal antibodies that are designed specifically to block infection of SARS-CoV-2.

Multiple analyses have shown that the antibody cocktail retains potency against the main variants of concern, including Delta, Gamma, Beta, and Mu, with information available in the Fact Sheet for Healthcare Providers. Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants.