美国食品和药物管理局批准了mitapivat治疗成人血贫血,改善血红蛋白和减少输血.
The FDA approved mitapivat for thalassemia anemia in adults, improving hemoglobin and reducing transfusions.
美国食品药品管理局(FDA)批准Agios制药公司AQVESME(imapivat)为患有甲型或乙型血清的成年人治疗贫血症,甲型或乙型血清是经批准用于非传染依赖和输血依赖形式的第一种药物。
The U.S. FDA has approved Agios Pharmaceuticals’ AQVESME (mitapivat) for treating anemia in adults with alpha- or beta-thalassemia, the first drug approved for both non-transfusion-dependent and transfusion-dependent forms.
根据第三期试验结果,口服的酸盐激酶激活剂改善了血红蛋白水平,减少了输血需求,提高了生活质量.
Based on Phase 3 trial results, the oral pyruvate kinase activator improved hemoglobin levels, reduced transfusion needs, and enhanced quality of life.
预计2026年1月底,在实施了REMS方案以监测肝脏安全后,由于罕见的肝细胞损伤病例,预计到2026年1月底将可提供。
Availability is expected in late January 2026, following implementation of a REMS program to monitor liver safety due to rare cases of hepatocellular injury.