Sanofi Receives the MHLW’s Marketing Authorization for Altuviiio to Treat Hemophilia A
Shots:
- Sanofi’ Altuviiio, a high-sustained factor VIII replacement therapy received marketing authorization from the MHLW to control bleeding tendency in patients with hemophilia A (factor VIII deficiency)
- The approval was based on the positive results incl. the (XTEND-1) trial in adults & adolescents and the (XTEND-Kids) trial in children under 12yrs. evaluating Altuviiio (50 IU/kg, qw). In the (XTEND-1) study, Altuviiio met the 1EPs & 2EPs i.e., significant bleed protection with a mean & median ABR of 0.71 & 0.00, reduction in ABR (77%) vs prior factor VIII prophylaxis-based on an intra-patient comparison
- In the (XTEND-Kids) study, children experienced a mean & median ABR of 0.6 & 0 while the safety results were consistent with the (XTEND-1) trial
Ref: Globenewswire | Image: Sanofi
Related News:- Sanofi and Sobi Present P-III Study (XTEND-Kids) Results of Altuviiio for Severe Hemophilia A at ISTH 2023
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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.
