Sanofi Announces Data Showing Effective Bleed Protection in Children with Severe Hemophilia A
Pivotal data from the Phase 3 XTEND-Kids study evaluating ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis, a factor VIII replacement therapy, in previously treated patients younger than 12 years of age with severe hemophilia A were presented recently in a late-breaking session at the Annual Meeting of the International Society on Thrombosis and Haemostasis in Montreal, Cananda.
The oral presentation detailed results from the XTEND-Kids study and confirmed that ALTUVIIIO met the primary endpoint with no inhibitor development to factor VIII detected, and key secondary endpoints including annualized bleeding rate (ABR) and maintenance of factor VIII activity above pre-specified levels.
In the pediatric population, clearance of administered factor concentrates in the blood is greater than in adults, often meaning injections are needed 2-4 times per week using standard (SHL) or extended half-life (EHL) factor VIII products. These data confirm that a once-weekly 50 IU/kg dose of ALTUVIIIO provides highly effective bleed protection in both children and adults and can be used across clinical scenarios.
Read the full press release here.
Source: Hemophilia Federation of America, June 2023