Sanofi and Sobi Present P-III Study (XTEND-Kids) Results of Altuviiio for Severe Hemophilia A at ISTH 2023
- The P-III study evaluating Altuviiio (50IU/kg, qw for 52wks.) in 75 patients aged ≤12yrs. The trial met 1EPs with no inhibitor development to factor VIII detected, median & mean ABRs were 0.00 & 0.89
- 64% had zero bleeding episodes, 82% & 88% had zero joint bleeds & spontaneous bleeds, was well-tolerated with a similar safety profile to (XTEND-1) trial confirming safety and efficacy in adults & children with highly effective bleed protection. The 2EPs incl. ABR & maintenance of factor VIII activity above pre-specified levels
- No serious allergic reactions, anaphylaxis, or embolic or thrombotic events were seen. Altuviiio was approved in the US for routine prophylaxis, on-demand treatment to control bleeding episodes & perioperative management in adults & children with hemophilia A
Ref: Sanofi | Image: Sanofi
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