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CHMP支持欧盟批准六项新疗法

2018-03-26 MedSci MedSci原创

六项新疗法
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由欧洲药品管理局人用药品委员会推荐的六种药物为其在欧洲的获批迈出了一大步。这批药物包括一种孤儿药，Clovis Oncology UK的Rubraca (rucaparib)，它已被开发用于治疗复发或进展性卵巢癌。该药物是一种多聚（ADP-核糖）聚合酶（PARP）的抑制剂，可阻断癌细胞中受损DNA的修复，并因此导致癌细胞死亡。ViiV Healthcare UK的Juluca对艾滋病治疗方面收到了


由欧洲药品管理局人用药品委员会推荐的六种药物为其在欧洲的获批迈出了一大步。

这批药物包括一种孤儿药，Clovis Oncology UK的Rubraca (rucaparib)，它已被开发用于治疗复发或进展性卵巢癌。

该药物是一种多聚（ADP-核糖）聚合酶（PARP）的抑制剂，可阻断癌细胞中受损DNA的修复，并因此导致癌细胞死亡。

ViiV Healthcare UK的Juluca对艾滋病治疗方面收到了积极的意见。

ViiV的dolutegravir（一种整合酶链转移抑制剂）和Janssen的rilpivirine（一种非核苷逆转录酶抑制剂）组成的药丸每日只需服用一次。

根据CHMP，去年十一月在美国获得批准的Juluca的益处是其能够保持对缺乏整合酶抑制剂抗性的HIV毒株的病毒抑制。

委员会对两种生物仿制药物表示祝贺：Amgen的Kanjinti（曲妥珠单抗）用于治疗乳腺癌和胃癌； 和Sandoz'Zessly（英夫利昔单抗）用于治疗类风湿性关节炎，克罗恩氏病，溃疡性结肠炎，强直性脊柱炎，银屑病关节炎和牛皮癣。

两种仿制药也获得批准：Pemetrexed Krka（培美曲塞），用于治疗恶性胸膜间皮瘤和非小细胞肺癌； 和Prasugrel Mylan（普拉格雷），用于预防动脉粥样硬化血栓。

在不利的方面，Portola Pharma UK的Dexxience (betrixaban)并没有被推荐批准，因为该机构认为临床数据并不能令人满意地显示出该药物的益处超过了它的风险，因近期患者因血液凝块的副作用而入院。

同样，Radius International公司的实验性骨质疏松症治疗药物Eladynos（abaloparatide）被CHMP拒绝，该研究表示，主要研究并未令人满意地表明该疗法对于已经经过绝经期的妇女预防非椎骨骨折有效。

委员会指出，两个研究点的数据不可靠，不得不被排除，因为该研究并未遵循"良好临床实践"进行，并且还列出了药物对心脏的影响，例如心率和心悸增加。

CHMP还确认了其之前的建议，即拒绝批准Pharma Mar的Aplidin（plitidepsin）用于治疗多发性骨髓瘤。

该研究小组得出结论，主要研究数据显示，与单独使用地塞米松治疗的患者相比，服用Aplidin的患者生活时没有病情恶化的时间仅有1个月左右的适度增加，但总体生存率的改善不足。

关于安全性，Aplidin和地塞米松的组合比单独使用地塞米松更频繁地报告了严重的副作用，因此委员会无法得出结论，该药物的益处超过了其风险。


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    2018-03-28 医生2394

    #CHMP#

    0

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    2018-03-28 kcb074

    #新疗法#

    0

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    2018-03-28 chenwq14

    #欧盟批准#

    0

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    2018-03-27 orangesking

    好

    0