FDA approves Sanofi’s Altuviiio
The Food and Drug Administration has approved Sanofi’s Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], a first-in-class, high-sustained factor VIII replacement therapy.
Altuviiio is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A. It is the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis, Sanofi said.
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Paul Hudson CEO of Sanofi said, "Today’s approval of Altuviiio allows patients and physicians to reimagine living with hemophilia. The high sustained factor activity levels that can be achieved with Altuviiio have the potential to change the hemophilia landscape. For the first time, with a once-weekly dose, powerful bleed protection is a reality for patients. Significant shifts in treatment paradigms that improve people’s lives, like Altuviiio, are what we have committed to delivering at Sanofi."
Lynn Malec, medical director of the 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, said, “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. By maintaining high levels of factor activity throughout the week, patients can be confident in the bleed protection Altuviiio offers.”