Sanofi : ALTUVIIIO XTEND-Kids Phase 3 Data Transforming Severe Hemophilia A Treatment For Children

(RTTNews) - The New England Journal of Medicine or NEJM published ALTUVIIIO XTEND-Kids phase 3 data supporting its potential to transform the treatment landscape for children with severe hemophilia A, Sanofi - Aventis Groupe said in a statement.

ALTUVIIIO (efanesoctocog alfa), a first-in-class, high-sustained factor VIII replacement therapy, is approved for adults and children with hemophilia A for routine prophylaxis and on-demand treatment to control bleeding episodes as well as for perioperative management (surgery).

Sanofi noted that the pivotal XTEND-Kids study published in NEJM showed ALTUVIIIO met primary and secondary endpoints, which included occurrence of factor VIII inhibitors and annualized bleed rates (ABRs). The results show no inhibitor development to factor VIII was detected with ALTUVIIIO. The median annualized bleed rate (ABR) was 0.00, and the estimated mean ABR was 0.61 (0.42-0.90) in the study of 73 patients treated per protocol. In the pediatric population, clearance of administered factor concentrates from 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.

The company noted that the eighty-two percent of the children treated with once-weekly ALTUVIIIO had zero joint bleeds, demonstrating ALTUVIIIO weekly prophylaxis has the potential to provide long-term preservation of joint health.

ALTUVIIIO is currently approved and marketed in the US, Taiwan, and Japan. On June 17, 2024, it was approved by the European Commission for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A under the name ALTUVOCT.

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