美国批准用于偏头痛预防的药物Aimovig

2018-05-20 MedSci MedSci原创

Amgen和Novartis的Aimovig已经成为第一个在美国获得监管许可的抗CGRP疗法,赢得了偏头痛预防的批准。单克隆抗体为患者提供了一种新的治疗方法,作为第一个阻断降钙素基因相关肽受体(CGRP-R)的基因,该基因被认为在偏头痛中起着关键作用。其作用方式不同于开发中的其他类似偏头痛疗法,其靶向CGRP本身而不是受体途径。IIIb期LIBERTY试验评估了Aimovig(erenumab)在


Amgen和Novartis的Aimovig已经成为第一个在美国获得监管许可的抗CGRP疗法,赢得了偏头痛预防的批准。

单克隆抗体为患者提供了一种新的治疗方法,作为第一个阻断降钙素基因相关肽受体(CGRP-R)的基因,该基因被认为在偏头痛中起着关键作用。

其作用方式不同于开发中的其他类似偏头痛疗法,其靶向CGRP本身而不是受体途径。

IIIb期LIBERTY试验评估了Aimovig(erenumab)在偶发性偏头痛患者中的作用,他们之前曾尝试过2至4次治疗但未成功,因此代表了偏头痛预防试验通常排除的难以治疗的人群。

结果显示,服用该药的患者与安慰剂相比,他们的偏头痛天数减少了近三倍或更多,而服用Aimovig的患者减少了两倍以上(分别为30.3%和13.7%)。

"专门解决偏头痛复杂性质的治疗方案是头痛医学领域迈出的重要和可喜的一步。Aimovig为各种患者提供了具有可靠疗效的自我管理,包括那些以前尝试过其他预防性治疗而未获成功的患者,"达特茅斯医学院Geisel医学院神经学教授Stewart Tepper说。

"重要的是,在临床试验中,Aimovig患者能够开始并继续接受治疗 - 由于不良事件而停药2%,并且经历了持续的偏头痛预防。"

诺华和Amgen计划在美国共同商业化Aimovig,而Amgen在日本和世界其他地方拥有独家商业化权利。

该药物预计将于一周内在美国上市,其价格为575美元,每月70mg或140mg单次使用预充式自动注射器,即每年6900美元。

"Aimovig的价格反映了它给患者和社会带来的价值,包括对患者,护理人员和雇主的财务影响,同时也考虑到患者的负担能力以及公平和及时的获取等关键问题,"诺华表示。

世界卫生组织认为偏头痛是男性和女性残疾的十大原因之一,但它仍然是一个未得到满足的重大医疗需求领域。

该药物自去年6月以来一直在欧盟进行审查,诺华表示预计将在未来几个月批准。


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    2018-06-02 zwjnj2

    好好学习天天向上

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    2018-05-22 pcw110
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    2018-05-20 1ddf0692m34(暂无匿称)

    学习了.长知识

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    2018-05-20 183****7028

    学习

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