Pharma Focus Asia

FDA Approves Once-Weekly ALTUVIIIO™, a New Class of Factor VIII Therapy

Thursday, February 23, 2023

The U.S. Food and Drug Administration (FDA) has approved ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, 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. ALTUVIIIO 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.

The approval of ALTUVIIIO allows patients and physicians to reimagine living with hemophilia. The high sustained factor activity levels are achieved with ALTUVIIIO and consist of the potential to change the hemophilia landscape. This approval marks an important clinical advancement for the hemophilia community by achieving higher levels of factor activity with a single simplified weekly dose.

ALTUVIIIO is indicated for routine prophylaxis, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding. The simple recommended dose of 50 IU/kg is intended for all patients and for different clinical scenarios.

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