欧盟批准C5补体抑制剂ULTOMIRIS用于治疗阵发性睡眠性血红蛋白尿(PNH)成人患者

2019-07-04 不详 MedSci原创

亚力兄制药公司宣布,欧盟委员会已批准ULTOMIRIS(ravulizumab)--第一个也是唯一的长效C5补体抑制剂,每八周服用一次用于治疗高疾病活动度的阵发性睡眠性血红蛋白尿(PNH)成年患者。

亚力兄制药公司宣布,欧盟委员会已批准ULTOMIRIS(ravulizumab)--第一个也是唯一的长效C5补体抑制剂,每八周服用一次用于治疗高疾病活动度的阵发性睡眠性血红蛋白尿(PNH)成年患者。

PNH是一种极为罕见且严重的疾病,如果不及时治疗,可能会引起多种衰弱症状和并发症,包括血栓形成。当血凝块存在于血管内并减缓或阻止血液流过循环系统时,就会导致血栓的形成。严重的血栓会导致器官损伤,中风,心脏病发作和潜在的过早死亡。

欧盟委员会的批准是基于两项第三阶段研究的综合结果,这些研究最近在Blood杂志中发表。在这些研究中所有11个主要和次要终点显示,每8周使用一次ULTOMIRIS的疗效并不低于每两周服用SOLIRIS治疗的疗效。ULTOMIRIS的安全性与SOLIRIS相似。其他数据显示ULTOMIRIS提供及时且彻底的C5抑制,消除了与C5不完全抑制相关的突破性溶血。

美国食品和药物管理局(FDA)于2018年12月21日批准ULTOMIRIS用于PNH成人患者。日本厚生劳动省(MHLW)于2019年6月18日批准ULTOMIRIS治疗成人PNH 。

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    2020-02-26 jklm09
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    2019-11-22 smallant2002
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    2019-09-01 Midas

    国内怎么购买呢

    0

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    2019-07-06 liuli5083
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