CHMP建议批准SOLIRIS(eculizumab)治疗神经脊髓炎光谱障碍

2019-07-28 Allan MedSci原创

Alexion制药公司近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)已发布积极意见,以扩大SOLIRIS®(eculizumab)目前的上市授权,包括治疗成人神经脊髓炎光谱障碍(NMOSD)患者。

Alexion制药公司近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)已发布积极意见,以扩大SOLIRIS®eculizumab)目前的上市授权,包括治疗成人神经脊髓炎光谱障碍(NMOSD)患者。欧盟委员会将审查CHMP的意见,预计最终决定将在两个月内完成。

NMOSD是一种罕见的、破坏性的、补体介导的中枢神经系统疾病,其特征在于复发。每次复发都导致残疾的逐步积累,包括失明和瘫痪,有时甚至过早死亡。NMOSD首次发病的平均年龄仅为39岁。NMOSD之前被称为Devic’s病,经常与其他神经系统疾病(如多发性硬化症)相混淆。


原始出处:

http://www.firstwordpharma.com/node/1655238#axzz5uxD07TwI

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    2020-06-19 snf701207
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    2019-11-30 xlysu
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    2020-01-06 zsyan
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    2019-07-30 医生2394

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