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Teva的皮下哮喘药物在III期临床试验中失败

2018-01-23 MedSci MedSci原创

皮下哮喘药物III期临床试验失败
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Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准，但由于两项后期研究未能达到其目标，该公司的新产品交付方式遇到了障碍。Cinquair/Cinqaero (reslizumab)是一种白细胞介素-5拮抗剂单克隆抗体，在市场上作为一种静脉注射剂，用于治疗患有严重哮喘的成人和嗜酸性粒细胞表型(超过400/mcL)。Teva正在开发使用预充式注射器进行皮下给药的药物，但在两个III


Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准，但由于两项后期研究未能达到其目标，该公司的新产品交付方式遇到了障碍。

Cinquair/Cinqaero (reslizumab)是一种白细胞介素-5拮抗剂单克隆抗体，在市场上作为一种静脉注射剂，用于治疗患有严重哮喘的成人和嗜酸性粒细胞表型(超过400/mcL)。

Teva正在开发使用预充式注射器进行皮下给药的药物，但在两个III期临床试验的主要终点被错过之后，这种情况目前还不确定。

在注册研究中，使用预充式注射器皮下注射reslizumab未能显着降低不能控制和血液嗜酸性粒细胞（>300/mcL）升高的哮喘患者出现临床哮喘急性发作（CAE）的频率。

此外，评估口服皮质类固醇（OCS）依赖性哮喘患者皮下注射reslizumab的III期索赔支持研究未能诱导每日OCS剂量的减少。

Teva公司专业临床开发和医疗事务高级副总裁Tushar Shah说："我们很失望，以固定剂量110mg皮下注射的这种雷珠单抗制剂试验并不符合他们的主要终点。"

然而，他还指出，这些数据强化了嗜酸性粒细胞在严重哮喘病生物学中的作用，以及为患者选择确定正确的血液嗜酸性粒细胞分界点的重要性。

该注册试验数据的分析结果显示，血液嗜酸性粒细胞计数超过400/mcL的患者CAE风险显着下降，该公司表示，现在将审查全部数据以确定下一步骤。


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    #I期临床#

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    2018-12-29 zhouqu_8

    #II期临床试验#

    0

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objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Nov 26 08:10:00 CST 2018, time=2018-11-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2035635, encodeId=38052035635cc, content=<a href='/topic/show?id=5fa83995011' target=_blank style='color:#2F92EE;'>#哮喘药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=39950, encryptionId=5fa83995011, topicName=哮喘药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e2e0330, createdName=huangdf, createdTime=Fri Jul 06 05:10:00 CST 2018, time=2018-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282300, encodeId=f5db282300d5, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281372, encodeId=be4a2813e2d0, content=Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准.但由于两项后期研究未能达到其目标.该公司的新产品交付方式遇到了障碍., beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:32:59 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-11-26 juliusluan78

    #III#

    0

  5. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281372, encodeId=be4a2813e2d0, content=Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准.但由于两项后期研究未能达到其目标.该公司的新产品交付方式遇到了障碍., beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:32:59 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-07-06 huangdf

    #哮喘药#

    0

  6. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281372, encodeId=be4a2813e2d0, content=Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准.但由于两项后期研究未能达到其目标.该公司的新产品交付方式遇到了障碍., beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:32:59 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-01-26 1217549fm29暂无昵称

    henhao

    0

  7. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281372, encodeId=be4a2813e2d0, content=Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准.但由于两项后期研究未能达到其目标.该公司的新产品交付方式遇到了障碍., beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:32:59 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-01-25 guihongzh

    #II期临床#

    0

  8. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281372, encodeId=be4a2813e2d0, content=Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准.但由于两项后期研究未能达到其目标.该公司的新产品交付方式遇到了障碍., beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:32:59 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-01-25 guihongzh

    #III期临床试验#

    0

  9. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281372, encodeId=be4a2813e2d0, content=Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准.但由于两项后期研究未能达到其目标.该公司的新产品交付方式遇到了障碍., beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:32:59 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-01-25 智智灵药

    #III期#

    0

  10. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281372, encodeId=be4a2813e2d0, content=Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准.但由于两项后期研究未能达到其目标.该公司的新产品交付方式遇到了障碍., beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:32:59 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-01-23 有备才能无患

    Teva公司寻求扩大其呼吸药物Cinquair/Cinqaero的批准.但由于两项后期研究未能达到其目标.该公司的新产品交付方式遇到了障碍.

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