FDA Grants Priority Review to Sanofi and Sobi’s Hemophilia A Drug Candidate

The FDA has granted Priority Review to Sanofi and Sobi’s Biologics License Application (BLA) for its efanesoctocog alfa candidate BIVV001 for treatment of patients with hemophilia A.

Efanesoctocog alfa is an investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A.

The BLA is supported by data from a phase 3 study, but the investigational therapy’s efficacy and safety have not been evaluated by any regulatory authority, the companies said.

The FDA previously granted BIVV001 Breakthrough Therapy, Fast Track and Orphan Drug designations. The agency’s target decision date on the BLA is Feb. 28, 2023.