FDA Extends Review of Regeneron Regen-Cov BLA

FDA has extended by three months its review of a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. “The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review,” the company says. The agency considers the additional data a major amendment, with a revised user fee review action target date of 7/13.

Regen-Cov first obtained an Emergency Use Authorization 11/2020. In January, FDA amended the EUA to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment. Currently, the therapy is not authorized for use in any U.S. states, territories or jurisdictions, according to the company.