FDA has approved efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy for adults and children over 12 years old with hemophilia A.
The US Food and Drug Administration has approved efanesoctocog alfa , a first-in-class, high-sustained factor VIII replacement therapy for adults and children over 12 years old with hemophilia A.
The product is used once a week and is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as to control bleeding during surgery .is “the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis.
With this product,"we have the opportunity to provide near normal factor activity levels for an extended period of time with a single dose, which is a first for hemophilia A," Angela Weyand, MD, of Michigan Medicine,who was involved in the pivotal phase 3 XTEND-1 trial that led to approval.. The results show that one injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes in the overall patient population and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range for most of the week, as
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