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

News Healthcare & Pharma Law & Policy Updates

Date: 10th May, 2025 Source: Saudi Food and Drug Authority (SFDA) Country: Saudi Arabia Original Source

Brief

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.

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Saudi Food and Drug Authority (SFDA)

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

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

Brief

Saudi Food and Drug Authority (SFDA)

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