Posted by Michael Wonder on 01 Jun 2022
FDA grants efanesoctocog alfa breakthrough therapy designation for haemophilia A
1 June 2022 - Designation is based on XTEND-1 Phase 3 study data demonstrating a clinically meaningful prevention of bleeds and superiority in prevention of bleeding episodes compared to prior prophylaxis factor treatment.
The United States FDA has granted breakthrough therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with haemophilia A.
Sanofi and Sobi collaborate on the development and commercialization of efanesoctocog alfa.
