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杨森旗下耐多药结核病药物Sirturo获CHMP上市许可推荐

2013-12-25 fyc5078 dxy

杨森耐多药结核病药物Sirturo获
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欧洲药品管理局专家顾问已推荐批准杨森旗下孤儿药Sirturo (Bedaquiline)用于治疗多重抗药性结核病。该药物将作为合并用药的一部分用于治疗耐药性或其它阻碍有效治疗的耐受性成人患者肺耐多药结核病。 如果这项决定获得欧盟委员会批准，该药物将获得一个有条件的许可，因为全面的效益-风险数据仍未获得，杨森还将必须对Sirturo进行更进一步的研究，欧盟委员会通常会在CHMP提出建议后三个月内做

欧洲药品管理局专家顾问已推荐批准杨森旗下孤儿药Sirturo (Bedaquiline)用于治疗多重抗药性结核病。该药物将作为合并用药的一部分用于治疗耐药性或其它阻碍有效治疗的耐受性成人患者肺耐多药结核病。

如果这项决定获得欧盟委员会批准，该药物将获得一个有条件的许可，因为全面的效益-风险数据仍未获得，杨森还将必须对Sirturo进行更进一步的研究，欧盟委员会通常会在CHMP提出建议后三个月内做出是否批准的决定。

Sirturo通过抑制分枝杆菌ATP（5'-三磷酸腺苷）合成酶而起作用，是该类药物中的首款药物，分枝杆菌ATP（5'-三磷酸腺苷）合成酶是结核分枝杆菌能量产生所必需的一种酶。CHMP认为Sirturo可以为肺耐多药结核病提供一种新的治疗选择，而肺耐多药结核病具有很高的致死率，对公众健康造成严重威胁。

肺结核在欧盟影响了大约十万分之二十三的人口，这种疾病在欧盟属于罕见疾病。近年来，结核病对至少包括异烟肼和利福平（两款主要的抗结核治疗药物）在内的一线治疗药物的耐药负担因缺乏新的治疗药物已迅速增加，不过这种情况最近似乎有所改善。

Sirturo是在过去两个月内第三款获得CHMP积极意见的药物，之前有大冢制药用于治疗多重抗药性结核病的Deltyba和Lucane制药的对氨水杨酸Lucane。

然而，根据Medicins Sans Frontieres的说法，即使这些新的治疗药物进入市场，但仍需要对这些药物的最佳使用方法进行研究。

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    2014-09-30 xinxin088

    #上市许可#

    0

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    2014-03-24 xiongyl1207

    Sirturo通过抑制分枝杆菌ATP（5'-三磷酸腺苷）合成酶而起作用，Deltyba和Lucane

    临床研究期待中

    0

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    2013-12-27 huhuaidong387

    #结核#

    0

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    2013-12-27 医生2394

    #CHMP#

    0

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    2013-12-27 mgqwxj

    #耐多药结核病#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1694083, encodeId=21ca1694083bd, content=<a href='/topic/show?id=adb8198e07a' target=_blank style='color:#2F92EE;'>#上市许可#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19870, encryptionId=adb8198e07a, topicName=上市许可)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Tue Sep 30 11:02:00 CST 2014, time=2014-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=8648, encodeId=fc61864820, content=Sirturo通过抑制分枝杆菌ATP（5'-三磷酸腺苷）合成酶而起作用，Deltyba和Lucane <br> <br> 临床研究期待中, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b12498217, createdName=xiongyl1207, createdTime=Mon Mar 24 22:47:00 CST 2014, time=2014-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1253897, encodeId=513e125389e57, content=<a href='/topic/show?id=f30ae86297d' target=_blank style='color:#2F92EE;'>#结核#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78629, encryptionId=f30ae86297d, topicName=结核)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=huhuaidong387, createdTime=Fri Dec 27 02:02:00 CST 2013, time=2013-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302620, encodeId=b2941302620b7, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Fri Dec 27 02:02:00 CST 2013, time=2013-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1458394, encodeId=182f14583949d, content=<a href='/topic/show?id=a39f803557a' target=_blank style='color:#2F92EE;'>#耐多药结核病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80355, encryptionId=a39f803557a, topicName=耐多药结核病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fa6e6064686, createdName=mgqwxj, createdTime=Fri Dec 27 02:02:00 CST 2013, time=2013-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1543199, encodeId=f3ec1543199d3, content=<a href='/topic/show?id=f2be61592eb' target=_blank style='color:#2F92EE;'>#杨森#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=61592, encryptionId=f2be61592eb, topicName=杨森)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=421413558235, createdName=陆成振, createdTime=Fri Dec 27 02:02:00 CST 2013, time=2013-12-27, status=1, ipAttribution=)]
    2013-12-27 陆成振

    #杨森#

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