Hemophilia monthly siRNA prophylaxis FDA approval with antithrombin targeting therapy treatment
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Sanofi Receives FDA Approval for Fitusiran in Hemophilia A and B

Sanofi announces FDA approval of fitusiran for adults and adolescents with hemophilia A or B with or without inhibitors, providing a new monthly subcutaneous prophylaxis option.

Sanofi today announced that the FDA has approved fitusiran for the prevention of bleeding episodes in adults and adolescents 12 years and older with hemophilia A or B with or without inhibitors. In the Phase 3 ATLAS trial program, fitusiran demonstrated statistically significant reductions in annualized bleeding rates compared to on-demand factor therapy. Fitusiran is a subcutaneous, once-monthly siRNA that reduces antithrombin levels to rebalance hemostasis. This approval provides hemophilia patients, including those with inhibitors, with a new convenient monthly prophylaxis option.

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