Regeneron Seeks Approval for Covid Therapy

FDA has accepted for priority review a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. Currently, the therapy is authorized 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. The agency has set a 4/13/2022 review action target date.

The submission is supported by two positive Phase 3 trials involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV in the patient populations, according to the company. A second BLA submission for treating patients hospitalized due to Covid-19 is expected to be submitted later this year.