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Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.
FDA granted approval to Sanofi’s Altuviiio (Antihemophilic Factor [Recombinant] Fc-VWF-XTEN Fusion Protein-ehtl), a factor VIII replacement therapy, on Feb. 23, 2023. The treatment is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management, for adults and children with hemophilia A.
FDA based its approval in part on data from the pivotal XTEND-1 Phase III study, which found that once-weekly prophylaxis met the primary endpoint of providing significant bleed protection for people with severe hemophilia A. The treatment had a mean annualized bleeding rate (ABR) of 0.70 and a median ABR of 0.0. Additionally, it met the key secondary endpoint with a significant reduction of 77% in ABR versus prior factor prophylaxis based on an intra-patient comparison.
"Today’s approval of [Antihemophilic Factor (Recombinant) Fc-VWF-XTEN Fusion Protein-ehtl] allows patients and physicians to reimagine living with hemophilia,” said Paul Hudson, CEO, Sanofi, in a company press release. “The high sustained factor activity levels that can be achieved with [Antihemophilic Factor (Recombinant) Fc-VWF-XTEN Fusion Protein-ehtl] 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.”
This is Antihemophilic Factor (Recombinant) Fc-VWF-XTEN Fusion Protein-eht’s first approval, which FDA granted after also granting priority review, breakthrough therapy, fast track, and orphan drug designations. Regulatory submission to the European Union is expected to occur in the second half of 2023.