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March 28, 2025
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The FDA approved fitusiran (Qfitlia, Sanofi) for routine prophylaxis for prevention or reduction in bleeding episodes in patients with hemophilia A or hemophilia B who are above 12 years old, according to a press release.
Fitusiran (Qfitlia, Sanofi) does not replace the missing clotting factor. However, it does reduce antithrombin levels, which leads to an increase in thrombin, an enzyme critical for blood clotting, the FDA said in the release.
The novel treatment is administered subcutaneously once every 2 months, and the dose and frequency of administration can be adjusted according to the INNOVANCE Antithrombin companion diagnostic test.
The most common side effects include viral infection, common cold symptoms and bacterial infection.
“Today’s approval of Qfitlia is significant for patients with hemophilia because it can be administered less frequently than other existing options,” Tanya Wroblewski, MD, deputy director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research said in the press release. “This new treatment option highlights our continued efforts to improve the lives of patients with hemophilia.”
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