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Sanofi Receives FDA Approval for Fitusiran in Hemophilia A and B with Inhibitors
Sanofi announces FDA approval of fitusiran (Alhemo) for adults and adolescents with hemophilia A or B with inhibitors to prevent or reduce bleeding episodes.
Sanofi today announced that the FDA has approved Alhemo (fitusiran) for the prevention or reduction of bleeding episodes in adults and adolescents aged 12 years and older with hemophilia A or B with inhibitors. Fitusiran is a subcutaneous RNA interference therapy targeting antithrombin that demonstrated a 90% reduction in annualized bleeding rate compared to on-demand treatment in the Phase 3 ATLAS-INH trial. The once-monthly subcutaneous dosing offers a convenient prophylaxis option for patients with inhibitors who have limited treatment choices.
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