依非巴司他：美国首次批准
Efanesoctocog Alfa: First Approval.
机构信息
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
出版信息
Drugs. 2023 May;83(7):633-638. doi: 10.1007/s40265-023-01866-9.
Efanesoctocog alfa (ALTUVIIIO; [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]), a von Willebrand factor (VWF) independent, recombinant DNA-derived Factor VIII (FVIII) concentrate, has been developed by Bioverativ Therapeutics, Inc (a Sanofi company) and Swedish Orphan Biovitrum AB (Sobi). Efanesoctocog alfa was approved in February 2023 in the USA for use in adults and children with hemophilia A (congenital FVIII deficiency) for: routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; perioperative management of bleeding. This article summarizes the milestones in the development of efanesoctocog alfa leading to this first approval for hemophilia A.
依非络司他奥（ALTUVIIIO；抗血友病因子（重组），Fc-VWF-XTEN 融合蛋白-ehtl），一种非血管性血友病因子（VWF）依赖性、重组 DNA 衍生的因子 VIII（FVIII）浓缩物，由 Bioverativ Therapeutics, Inc（一家赛诺菲公司）和瑞典 Orphan Biovitrum AB（Sobi）开发。依非络司他奥于 2023 年 2 月在美国获得批准，用于治疗成人和儿童的甲型血友病（先天性 FVIII 缺乏症）：常规预防以减少出血发作的频率；按需治疗和控制出血发作；围手术期出血管理。本文总结了依非络司他奥开发过程中的重要里程碑，最终获得了甲型血友病的首次批准。
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