Circassia的慢性阻塞性肺病药物喜获FDA批准

2019-04-02 不详 MedSci原创

该药物是长效毒蕈碱拮抗剂(LAMA)溴化丙啶(400 mcg)和长效β-激动剂(LABA)富马酸福莫特罗(12 mcg)的固定剂量组合,每日两次通过致动吸入器Pressair进行呼吸给药。

Circassia宣布美国食品和药物管理局(FDA)批准其Duaklir用于慢性阻塞性肺病(COPD)的维持治疗。

该药物是长效毒蕈碱拮抗剂(LAMA)溴化丙啶(400 mcg)和长效β-激动剂(LABA)富马酸福莫特罗(12 mcg)的固定剂量组合,每日两次通过致动吸入器Pressair进行呼吸给药。

Circassia首席执行官史蒂夫哈里斯表示:"我们很高兴FDA批准Duaklir,相信该药物会为美国大量COPD患者提供有价值的治疗选择。"

"Duaklir进一步加强了我们的呼吸系列产品的研发管线,我们期待在未来几个月在美国推出。"

该批准基于来自三项III期临床研究(ACLIFORM,AUGMENT和AMPLIFY)以及IV期ASCENT研究的数据,结果表明该疗法可有效减轻COPD的恶化。

原始出处:


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    2020-02-10 nymo
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    2020-01-06 tomyang96
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    2019-07-23 amy0559
  5. [GetPortalCommentsPageByObjectIdResponse(id=1839674, encodeId=d6c618396e449, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Dec 12 06:18:00 CST 2019, time=2019-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1649430, encodeId=509b1649430e0, content=<a href='/topic/show?id=081a16e10e8' target=_blank style='color:#2F92EE;'>#SSI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16710, encryptionId=081a16e10e8, topicName=SSI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=586523824746, createdName=nymo, createdTime=Mon Feb 10 22:18:00 CST 2020, time=2020-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1696878, encodeId=4aee16968e852, content=<a href='/topic/show?id=d2e99e651e4' target=_blank style='color:#2F92EE;'>#阻塞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97651, encryptionId=d2e99e651e4, topicName=阻塞)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a23129903429, createdName=tomyang96, createdTime=Mon Jan 06 18:18:00 CST 2020, time=2020-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1671921, encodeId=5a8216e19219f, content=<a href='/topic/show?id=58378220131' target=_blank style='color:#2F92EE;'>#肺病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82201, encryptionId=58378220131, topicName=肺病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2f0826868454, createdName=amy0559, createdTime=Tue Jul 23 09:18:00 CST 2019, time=2019-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1624920, encodeId=6a4516249208f, content=<a href='/topic/show?id=0333412062' target=_blank style='color:#2F92EE;'>#Cas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4120, encryptionId=0333412062, topicName=Cas)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=411420689333, createdName=yaanren, createdTime=Thu Apr 04 12:18:00 CST 2019, time=2019-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=364028, encodeId=453336402833, content=了解一下,谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=3, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Tue Apr 02 22:54:54 CST 2019, time=2019-04-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=364022, encodeId=0e11364022fd, content=学习了,涨知识了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDM9swhbgTo7nzqRKzMmzckmEoeTyLQVDCgjqsicjyhxPs0vPoYU6GsSYbCjSkNHicJkz3NL0a0EbUMVdNjkctXI6FocpGKaVr9E/0, createdBy=29392048316, createdName=王秀, createdTime=Tue Apr 02 21:42:09 CST 2019, time=2019-04-02, status=1, ipAttribution=)]
    2019-04-04 yaanren
  6. [GetPortalCommentsPageByObjectIdResponse(id=1839674, encodeId=d6c618396e449, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Dec 12 06:18:00 CST 2019, time=2019-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1649430, encodeId=509b1649430e0, content=<a href='/topic/show?id=081a16e10e8' target=_blank style='color:#2F92EE;'>#SSI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16710, encryptionId=081a16e10e8, topicName=SSI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=586523824746, createdName=nymo, createdTime=Mon Feb 10 22:18:00 CST 2020, time=2020-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1696878, encodeId=4aee16968e852, content=<a href='/topic/show?id=d2e99e651e4' target=_blank style='color:#2F92EE;'>#阻塞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97651, encryptionId=d2e99e651e4, topicName=阻塞)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a23129903429, createdName=tomyang96, createdTime=Mon Jan 06 18:18:00 CST 2020, time=2020-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1671921, encodeId=5a8216e19219f, content=<a href='/topic/show?id=58378220131' target=_blank style='color:#2F92EE;'>#肺病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82201, encryptionId=58378220131, topicName=肺病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2f0826868454, createdName=amy0559, createdTime=Tue Jul 23 09:18:00 CST 2019, time=2019-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1624920, encodeId=6a4516249208f, content=<a href='/topic/show?id=0333412062' target=_blank style='color:#2F92EE;'>#Cas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4120, encryptionId=0333412062, topicName=Cas)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=411420689333, createdName=yaanren, createdTime=Thu Apr 04 12:18:00 CST 2019, time=2019-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=364028, encodeId=453336402833, content=了解一下,谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=3, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Tue Apr 02 22:54:54 CST 2019, time=2019-04-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=364022, encodeId=0e11364022fd, content=学习了,涨知识了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDM9swhbgTo7nzqRKzMmzckmEoeTyLQVDCgjqsicjyhxPs0vPoYU6GsSYbCjSkNHicJkz3NL0a0EbUMVdNjkctXI6FocpGKaVr9E/0, createdBy=29392048316, createdName=王秀, createdTime=Tue Apr 02 21:42:09 CST 2019, time=2019-04-02, status=1, ipAttribution=)]
    2019-04-02 天地飞扬

    了解一下,谢谢分享!

    0

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    2019-04-02 王秀

    学习了,涨知识了!

    0

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