Sanofi has received marketing authorization from the Japanese Ministry of Health, Labor, and Welfare (MHLW) for ALTUVIIIO, a groundbreaking therapy for hemophilia A. ALTUVIIIO, also known as efanesoctocog alfa, is a high-sustained factor VIII replacement therapy that marks a significant advancement in controlling blood loss in hemophilia A patients.
ALTUVIIIO, an antihemophilic factor (recombinant) known as Fc-VWF-XTEN fusion protein, is designed to manage bleeding during surgeries, control bleeding episodes, and provide routine prophylaxis.
The recommended dosage for ALTUVIIIO, across various clinical scenarios and for all patients, is 50 IU/kg.
Sanofi claims that ALTUVIIIO is a groundbreaking treatment, offering normal to near-normal factor activity levels (over 40%) for most of the week with just once-weekly dosing in adults and adolescents. This represents a significant advancement in managing hemophilia A.
Furthermore, clinical trials have shown that ALTUVIIIO significantly reduces bleeding in comparison to previous factor VIII prophylaxis, particularly in adults and adolescents with severe hemophilia A.
This approval by the Japanese authorities is backed by positive data from pivotal trials, including the XTEND-1 trial involving adults and adolescents and the XTEND-Kids trial for children below the age of 12. In the XTEND-1 study, patients receiving ALTUVIIIO prophylaxis once a week achieved a mean annualized bleeding rate (ABR) of 0.71 and a median ABR of 0.00, meeting the primary endpoint for bleed protection. ALTUVIIIO also demonstrated a remarkable 77% reduction in ABR compared to previous factor VIII prophylaxis.
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