The SFDA Grants Breakthrough Designation to Qfitlia for Hemophilia A and B

On October 5, 2025, the Saudi Food and Drug Authority (SFDA) issued an update regarding "The SFDA Grants Breakthrough Designation to Qfitlia for Hemophilia A and B". This decision was made based on clinical data showing significant improvement in preventing bleeding episodes in patients with hemophilia A or B. The breakthrough designation allows Sanofi's medication, Fitusiran (Qfitlia), to be submitted and reviewed under the Breakthrough Track subject to specific regulatory controls.