经先前治疗的严重A型血友病该如何治疗?efanesoctocog alpha在临床试验中已达到主要终点

2022-03-14 Allan MedSci原创

在先前治疗的严重A型血友病患者中进行的 efanesoctocog alpha 的 III 期研究达到了其主要终点,以及一个关键的次要目标。

血友病多数是遗传性疾病,造成人体无法凝血形成血块来止血。这致使病人受伤后流血时间更长,易于淤青,和增加关节积血或脑出血的几率。关节内出血可能造成永久性的损伤,而脑出血可能造成长期的头痛、癫痫、或是意识不清。血友病可分为两种主要的型别,A型血友病为缺乏凝血因子 VIII,B型血友病为缺乏第9凝血因子。

制药公司赛诺菲(Sanofi)和 Sobi 近日宣布,在先前治疗的严重A型血友病患者中进行的 efanesoctocog alpha 的 III 期研究达到了其主要终点,以及一个关键的次要目标。两家公司指出,来自 XTEND-1 试验的数据将成为今年开始向监管机构提交的基础。

这项非随机研究包括 159 名 12 岁以上的严重A型血友病患者,这些患者之前接受过凝血因子 VIII 替代疗法。试验的预防组包括每周接受 50 IU/kg 剂量 efanesoctocog alpha 的受试者,持续 52 周。

一线结果显示,在 52 周内每周接受预防治疗的患者对出血事件的预防具有临床意义,平均年出血率 (ABR) 为0.71。

两家公司指出,efanesoctocog alpha 在该研究中具有良好的耐受性,没有患者产生凝血因子 VIII 抑制剂。最常见的治疗中出现的不良事件是头痛、关节痛、跌倒和背痛。

赛诺菲全球开发主管 Dietmar Berger 表示:“我们相信 efanesoctocog alpha 可提供更高的保护和更长的持续时间”。

Efanesoctocog alpha,也称为 BIVV001,是一种研究性重组凝血因子 VIII 疗法,旨在通过每周一次的预防性给药来延长对A型血友病患者的出血保护。 Sobi 决定在 2019 年选择开发该药物。

 

原始出处:

https://firstwordpharma.com/story/5521719

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    2023-02-16 habb
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    2022-04-11 yhy100200
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    2022-05-10 gao_jian4217
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    2022-09-15 jiekemin
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    2022-03-16 hongbochen

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