Sanofi Receives FDA Approval for Alhemo in Hemophilia A and B

Sanofi today announced that the FDA has approved Alhemo (fitusiran) for the prevention of bleeding episodes in adults and pediatric patients 12 years and older with hemophilia A or B with inhibitors. Alhemo is a subcutaneous RNA interference (RNAi) therapy that targets antithrombin to rebalance hemostasis in patients with hemophilia. In the Phase 3 ATLAS-INH trial, Alhemo demonstrated a statistically significant 90% reduction in the annualized bleeding rate compared to on-demand bypassing agent therapy. The once-monthly subcutaneous injection offers a convenient prophylaxis option for patients with hemophilia and inhibitors.