Sanofi’s Qfitlia Becomes First US-Approved Therapy for Hemophilia A or B
The FDA has approved Qfitlia (fitusiran), the first antithrombin-lowering therapy for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or hemophilia B patients (ages 12+) with or without inhibitors. Approval is based on ATLAS Phase III trials, which showed a 71% reduction in annualized bleeding rates (ABR) for patients without inhibitors and a 73% reduction for those with inhibitors. Qfitlia uses small-interfering RNA technology, allowing low-frequency, subcutaneous dosing.
“Current treatment options force trade-offs between bleed control and convenience,” said Ph...
