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Sanofi’s Altuviiio Receives the US FDA’s Approval for the Treatment of Hemophilia A

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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

Related Post:- Sanofi and Regeneron Receive EC’s Approval of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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