The U.S. Food and Drug Administration (FDA) has approved ALTUVIIIO ™, formerly known as efanesoctocog alfa, for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A.

ALTUVIIIO is Sanofi’s recombinant factor VIII therapy (rFVIII), manufactured through proprietary Fc fusion technologies to extend the half-life of the rFVIII, resulting in more sustained protection from bleeds per infusion. In contrast to other FVIII replacement therapies, it is independent of von Willebrand factor.

According to a new Sanofi release, the FDA approval is based on data from the pivotal XTEND-1 Phase 3 clinical study recently published in The New England Journal of Medicine. Results showed that once-weekly ALTUVIIIO prophylaxis provided “significant bleed protection” for people with severe hemophilia A with a mean annualized bleeding rate (ABR) of 0.70 and a median ABR of 0.0. The therapy was also associated with a significant reduction of 77% in ABR versus prior factor prophylaxis based on an intra-patient comparison.

“This approval marks an important clinical advancement for the hemophilia community because we have an option that can achieve higher levels of factor activity with a single simplified  weekly dose, stated Lynn Malec, MD, Medical Director of Comprehensive Center for Bleeding Disorders and Associate Investigator at The Versiti Blood Research Institute, and Associate Professor of Medicine and Pediatrics at The Medical College of Wisconsin. “By maintaining high levels of factor activity throughout the week, patients can be confident in the bleed protection ALTUVIIIO offers.”

Source: Sanofi press release dated February 23, 2023