The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO.
From SanofiSep 25 2023Reviewed by Lily Ramsey, LLM The Japanese Ministry of Health, Labor, and Welfare has granted marketing authorization for ALTUVIIIO®[Antihemophilic Factor , Fc-VWFXTEN Fusion Protein], a first-in-class, high-sustained factor VIII replacement therapy. ALTUVIIIO is indicated for control of bleeding tendency in patients with hemophilia A .
ALTUVIIIO can be used for routine prophylaxis, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding. The simple recommended dose of 50 IU/kg is intended for all patients and for different clinical scenarios. The severity of hemophilia is determined by the level of clotting factor activity in a person’s blood, and there is a negative correlation between risk of bleeding and factor activity levels. The MHLW approval is based on positive data from patients with severe hemophilia A, including the pivotal XTEND-1 trial in adults and adolescents and data from the XTEND-Kids trial in children under 12 years of age.
Data from XTEND-Kids, showed that children younger than 12 years of age receiving once-weekly ALTUVIIIO for 52 weeks experienced a mean ABR of 0.6 and a median ABR of 0 . Safety results were consistent with data from the XTEND-1 trial. Across these studies, ALTUVIIIO has an established safety profile and there were no reports of 2/3 factor VIII inhibitor development, although inhibitor formation is possible following administration of ALTUVIIIO.
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