Posted by Michael Wonder on 30 Aug 2022
FDA grants priority review to efanesoctocog alfa for people with haemophilia A
30 August 2022 - Priority review based on pivotal data from the XTEND-1 Phase 3 study.
The US FDA has accepted for priority review the biologics license application for efanesoctocog alfa (BIVV001) for the treatment of haemophilia A.
The target action date for the FDA decision is 28 February 2023.
