赛诺菲将Dupixent用于严重哮喘

2018-03-04 MedSci MedSci原创

美国监管机构已接受Sanofi / Regeneron的生物制剂Dupixent作为某些成人和青少年中度至重度哮喘的辅助治疗药物。Dupixent是一种人类单克隆抗体,专门用于抑制IL-4和IL-13的信号传导,IL-4和IL-13是导致中度至重度哮喘中II型炎症的两种关键信号蛋白。该药物已经在市场上用于治疗特应性皮炎。哮喘的提交资料包括III期LIBERTY ASTHMA VENTURE研究的数


美国监管机构已接受Sanofi / Regeneron的生物制剂Dupixent作为某些成人和青少年中度至重度哮喘的辅助治疗药物。

Dupixent是一种人类单克隆抗体,专门用于抑制IL-4和IL-13的信号传导,IL-4和IL-13是导致中度至重度哮喘中II型炎症的两种关键信号蛋白。该药物已经在市场上用于治疗特应性皮炎。

哮喘的提交资料包括III期LIBERTY ASTHMA VENTURE研究的数据,该研究显示向标准疗法中添加Dupixent(dupilumab)平均使用维持口服皮质类固醇(OCS)的比例平均为70%,而使用安慰剂的比例为42%。

该药还显示平均OCS使用率降低80%,而基线嗜酸性粒细胞计数大于或等于300个细胞/微升的患者安慰剂使用率为43%。

赛诺菲预计美国食品和药物管理局将在2018年10月20日之前做出决定。


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    2018-03-06 梦想起航ing

    不错.学习了.谢谢分享

    0

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  5. 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channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Sun Mar 04 22:56:39 CST 2018, time=2018-03-04, status=1, ipAttribution=)]
    2018-03-05 1dd8c52fm63(暂无匿称)

    了解了解.继续关注

    0

  6. 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channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Sun Mar 04 22:56:39 CST 2018, time=2018-03-04, status=1, ipAttribution=)]
    2018-03-05 三生有幸9135

    学习一下谢谢分享

    0

  7. 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channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Sun Mar 04 22:56:39 CST 2018, time=2018-03-04, status=1, ipAttribution=)]
    2018-03-05 飛歌

    厉害了我的哥

    0

  8. 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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Mar 04 23:25:32 CST 2018, time=2018-03-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=292999, encodeId=f768292999f9, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/15/8213228fe923915543544ad3da7e1c64.jpg, createdBy=6bd82014262, createdName=秀红, createdTime=Sun Mar 04 22:56:50 CST 2018, time=2018-03-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=292995, encodeId=0837292995cc, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Sun Mar 04 22:56:39 CST 2018, time=2018-03-04, status=1, ipAttribution=)]
    2018-03-04 清风拂面

    谢谢分享学习

    0

  9. 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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Sun Mar 04 23:25:32 CST 2018, time=2018-03-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=292999, encodeId=f768292999f9, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/01/15/8213228fe923915543544ad3da7e1c64.jpg, createdBy=6bd82014262, createdName=秀红, createdTime=Sun Mar 04 22:56:50 CST 2018, time=2018-03-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=292995, encodeId=0837292995cc, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Sun Mar 04 22:56:39 CST 2018, time=2018-03-04, status=1, ipAttribution=)]
    2018-03-04 秀红

    学习了

    0

  10. 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channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Sun Mar 04 22:56:39 CST 2018, time=2018-03-04, status=1, ipAttribution=)]
    2018-03-04 131****2916

    不错的文章值得推荐

    0

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FDA解除对赛诺菲血友病药物的临床控制

美国食品和药物管理局在9月份取消了对该方案的临床控制权之后,赛诺菲和Alnylam的血友病治疗药物fitusiran面临的一个主要障碍已经被消除。以抗凝血酶(AT)为靶点的RNA干扰药物现在可以在没有抑制剂的情况下恢复血友病A和B患者的II期和III期临床试验,在一名血友病患者A的开放标签II期试验中出现一例致命血块后暂停。这两家公司制定了一项计划,以减少其他患者血栓形成的风险,并将其提交给FDA