FDA grants priority review to efanesoctocog alfa for people with haemophilia A
The FDA decision date for efanesoctocog alfa, an investigational factor VIII therapy, is set for 28 February 2023 Priority review is based on pivotal data from the XTEND-1 phase 3 study Efanesoctocog alfa delivers high sustained factor activity levels in the normal to near-normal range for the majority of the week with once weekly prophylaxis dosing, providing higher protection for longer The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of haemophilia