Sanofi’s Altuviiio Receives the US FDA’s Approval for the Treatment of Hemophilia A
Shots:
- The US FDA has approved Altuviiio indicated for routine prophylaxis & on-demand treatment to control bleeding episodes & perioperative management for adults & children with hemophilia A. The product will be available in April in the US
- The approval was based on the P-III study (XTEND-1) evaluating Altuviiio (qw) in 159 patients aged ≥12yrs. The trial met its 1EPs & 2EPs i.e., significant bleed protection with a mean ABR of 0.70, median ABR of 0.0, 77% reduction in ABR vs prior factor prophylaxis
- Prevention of joint bleeds with a median annualized joint bleeding rate of 0, 100% resolution of target joints, mean factor VIII activity ≥40% for most of the week & ≥10% at 7 Days, was well-tolerated with no reports of factor VIII inhibitor development. Regulatory submission of Altuviiio in the EU is expected in H2’23
Ref: Sanofi | Image: Sanofi
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