达比加群逆转剂获欧洲药品管理局人用医药产品委员会正面评价

● 第一个获得CHMP正面评价的非维生素K口服抗凝药特异性逆转剂

● 正面评价是基于临床研究结果，该结果显示idarucizumab在几分钟之内即可逆转达比加群的抗凝作用

德国殷格翰2015年9月28日电 /美通社/ -- 今天，欧洲药品管理局 （EMA）人用医药产品委员会（CHMP）给予了idarucizumab （将以Praxbind®作为商品名）正面评价，推荐其在欧洲获得批准。若获准，idarucizumab将用于接受泰毕全（达比加群酯）的成人患者需要 急诊手术/介入性操作或者出现危及生命或无法控制的出血并发症时，快速逆转达比加群的抗凝作用。［1］

欧洲心血管协会主席，葡萄牙里斯本大学Fausto J. Pinto教授指出：“CHMP推荐批准idarucizumab的正面评价是抗凝治疗领域的一个重要推荐。非维生素K 口服抗凝药 （NOACs）的诞生已经是抗凝领域的一个重大进步。批准特异性逆转剂来迅速停止这些药物的抗凝作用将是下一个进步。”

欧洲卒中组织主席，英国格拉斯哥大学Kennedy R. Lees教授评论道：“对于那些接受抗凝药物如达比加群治疗的卒中患者来说，这就像是蛋糕上的糖霜：在紧急情况下我们将有可能将他们所接受药物的作用迅速 地、安全地关掉。对医生和患者来说，这将使治疗选择更加容易。”

CHMP正面评价是基于健康受试者的试验数据及RE-VERSE AD™ 研究的期中分析结果。［2-5］在这些研究中，idarucizumab的逆转作用在使用5克该药物后几分钟之内即迅速显现。［2-4］在几乎所有患者中逆转作用完全并且持久。［2-5］没有发现与idarucizumab有关的严重不良反应事件。另外，在使用idarucizumab后未出现促凝作用。［2，5］

“我们的科学家为idarucizumab做了深入而持久的研究，所以现在我们对在欧洲获得批准推荐感到 非常兴奋，”勃林格殷格翰心血管治疗领域医学副总裁Jorg Kreuzer教授说道，“我相信idarucizumab将增加医生和患者选择达比加群的信心，因为达比加群是第一个拥有特异性逆转剂的NOAC。”

Idarucizumab目前处于全球监管部门审批过程中，［6］包括美国FDA。［7］勃林格殷格翰计划在所有达比加群获批的国家递交idarucizumab的上市申请。［6］

更多信息

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10. Pollack C. V. et al. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015;114(1):198-20.

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