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胆道闭锁治疗取得新进展：美国FDA已批准Odevixibat的IND申请

2020-01-30 Allan MedSci原创

FDA胆道闭锁Odevixibat
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开发新型胆汁酸调节剂的临床阶段生物制药公司Albireo今日宣布，Odevixibat治疗进行性家族性肝内胆汁淤积症（PFIC）、胆道闭锁和Alagille综合征的临床计划取得多项进展。美国FDA已批准该公司的研究性新药（IND）申请，以启动一项针对胆道闭锁的全球关键试验。

开发新型胆汁酸调节剂的临床阶段生物制药公司Albireo今日宣布，Odevixibat治疗进行性家族性肝内胆汁淤积症（PFIC）、胆道闭锁和Alagille综合征的临床计划取得多项进展。美国FDA已批准该公司的研究性新药（IND）申请，以启动一项针对胆道闭锁的全球关键试验。

Albireo总裁兼首席执行官Ron Cooper表示：“我们希望在2020年上半年启动胆道闭锁的关键试验”。胆道闭锁是一种只在新生儿期发生的进行性、特发性、纤维闭塞性肝外胆管树疾病，表现为胆道梗阻。虽然总发病率较低(约占活产婴儿的1/20000到1/1000)，但胆道闭锁是需要外科治疗的新生儿黄疸的最常见原因，并且是儿童肝移植最常见的指征。


原始出处：

https://www.firstwordpharma.com/node/1697123?tsid=4

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    2020-11-10 lidong50

    #Odevixibat#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1693956, encodeId=ee47169395623, content=<a href='/topic/show?id=4b7a13250fd' target=_blank style='color:#2F92EE;'>#Odevixibat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13250, encryptionId=4b7a13250fd, topicName=Odevixibat)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=26a429497310, createdName=lidong50, createdTime=Tue Nov 10 01:13:00 CST 2020, time=2020-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1930311, encodeId=87de1930311bc, content=<a href='/topic/show?id=87b8322658' target=_blank style='color:#2F92EE;'>#BAT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3226, encryptionId=87b8322658, topicName=BAT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4a4d285, createdName=日月, createdTime=Sun May 24 21:13:00 CST 2020, time=2020-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982320, encodeId=3165198232016, content=<a href='/topic/show?id=13b658e849' target=_blank style='color:#2F92EE;'>#Dev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5878, encryptionId=13b658e849, topicName=Dev)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bcaa382, createdName=fzwish20000, createdTime=Mon Dec 07 04:13:00 CST 2020, time=2020-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1463973, encodeId=7dbb14639e341, content=<a href='/topic/show?id=c5af8355eea' target=_blank style='color:#2F92EE;'>#胆道闭锁#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83557, encryptionId=c5af8355eea, topicName=胆道闭锁)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47726553775, createdName=marlenexl, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469152, encodeId=5efb1469152a4, content=<a href='/topic/show?id=211f98250b' target=_blank style='color:#2F92EE;'>#IND#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9825, encryptionId=211f98250b, topicName=IND)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=16377007930, createdName=xiaogang319, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551466, encodeId=3107155146667, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=378654, encodeId=8fcc3e8654d5, content=多半是先天发育不良, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/11/13/297abc49521542fee373596e497d37fc.jpg, createdBy=db695226500, createdName=1478fa69m73暂无昵称, createdTime=Thu Jan 30 14:06:12 CST 2020, time=2020-01-30, status=1, ipAttribution=)]
    2020-05-24 日月

    #BAT#

    0

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    2020-12-07 fzwish20000

    #Dev#

    0

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    2020-02-01 marlenexl

    #胆道闭锁#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1693956, encodeId=ee47169395623, content=<a href='/topic/show?id=4b7a13250fd' target=_blank style='color:#2F92EE;'>#Odevixibat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13250, encryptionId=4b7a13250fd, topicName=Odevixibat)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=26a429497310, createdName=lidong50, createdTime=Tue Nov 10 01:13:00 CST 2020, time=2020-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1930311, encodeId=87de1930311bc, content=<a href='/topic/show?id=87b8322658' target=_blank style='color:#2F92EE;'>#BAT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3226, encryptionId=87b8322658, topicName=BAT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4a4d285, createdName=日月, createdTime=Sun May 24 21:13:00 CST 2020, time=2020-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982320, encodeId=3165198232016, content=<a href='/topic/show?id=13b658e849' target=_blank style='color:#2F92EE;'>#Dev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5878, encryptionId=13b658e849, topicName=Dev)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bcaa382, createdName=fzwish20000, createdTime=Mon Dec 07 04:13:00 CST 2020, time=2020-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1463973, encodeId=7dbb14639e341, content=<a href='/topic/show?id=c5af8355eea' target=_blank style='color:#2F92EE;'>#胆道闭锁#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83557, encryptionId=c5af8355eea, topicName=胆道闭锁)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47726553775, createdName=marlenexl, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469152, encodeId=5efb1469152a4, content=<a href='/topic/show?id=211f98250b' target=_blank style='color:#2F92EE;'>#IND#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9825, encryptionId=211f98250b, topicName=IND)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=16377007930, createdName=xiaogang319, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551466, encodeId=3107155146667, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=378654, encodeId=8fcc3e8654d5, content=多半是先天发育不良, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/11/13/297abc49521542fee373596e497d37fc.jpg, createdBy=db695226500, createdName=1478fa69m73暂无昵称, createdTime=Thu Jan 30 14:06:12 CST 2020, time=2020-01-30, status=1, ipAttribution=)]
    2020-02-01 xiaogang319

    #IND#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1693956, encodeId=ee47169395623, content=<a href='/topic/show?id=4b7a13250fd' target=_blank style='color:#2F92EE;'>#Odevixibat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13250, encryptionId=4b7a13250fd, topicName=Odevixibat)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=26a429497310, createdName=lidong50, createdTime=Tue Nov 10 01:13:00 CST 2020, time=2020-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1930311, encodeId=87de1930311bc, content=<a href='/topic/show?id=87b8322658' target=_blank style='color:#2F92EE;'>#BAT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3226, encryptionId=87b8322658, topicName=BAT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4a4d285, createdName=日月, createdTime=Sun May 24 21:13:00 CST 2020, time=2020-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982320, encodeId=3165198232016, content=<a href='/topic/show?id=13b658e849' target=_blank style='color:#2F92EE;'>#Dev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5878, encryptionId=13b658e849, topicName=Dev)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bcaa382, createdName=fzwish20000, createdTime=Mon Dec 07 04:13:00 CST 2020, time=2020-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1463973, encodeId=7dbb14639e341, content=<a href='/topic/show?id=c5af8355eea' target=_blank style='color:#2F92EE;'>#胆道闭锁#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83557, encryptionId=c5af8355eea, topicName=胆道闭锁)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47726553775, createdName=marlenexl, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469152, encodeId=5efb1469152a4, content=<a href='/topic/show?id=211f98250b' target=_blank style='color:#2F92EE;'>#IND#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9825, encryptionId=211f98250b, topicName=IND)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=16377007930, createdName=xiaogang319, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551466, encodeId=3107155146667, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=378654, encodeId=8fcc3e8654d5, content=多半是先天发育不良, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/11/13/297abc49521542fee373596e497d37fc.jpg, createdBy=db695226500, createdName=1478fa69m73暂无昵称, createdTime=Thu Jan 30 14:06:12 CST 2020, time=2020-01-30, status=1, ipAttribution=)]
    2020-02-01 10518098zz

    #美国FDA#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1693956, encodeId=ee47169395623, content=<a href='/topic/show?id=4b7a13250fd' target=_blank style='color:#2F92EE;'>#Odevixibat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13250, encryptionId=4b7a13250fd, topicName=Odevixibat)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=26a429497310, createdName=lidong50, createdTime=Tue Nov 10 01:13:00 CST 2020, time=2020-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1930311, encodeId=87de1930311bc, content=<a href='/topic/show?id=87b8322658' target=_blank style='color:#2F92EE;'>#BAT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3226, encryptionId=87b8322658, topicName=BAT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4a4d285, createdName=日月, createdTime=Sun May 24 21:13:00 CST 2020, time=2020-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982320, encodeId=3165198232016, content=<a href='/topic/show?id=13b658e849' target=_blank style='color:#2F92EE;'>#Dev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5878, encryptionId=13b658e849, topicName=Dev)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bcaa382, createdName=fzwish20000, createdTime=Mon Dec 07 04:13:00 CST 2020, time=2020-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1463973, encodeId=7dbb14639e341, content=<a href='/topic/show?id=c5af8355eea' target=_blank style='color:#2F92EE;'>#胆道闭锁#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83557, encryptionId=c5af8355eea, topicName=胆道闭锁)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47726553775, createdName=marlenexl, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469152, encodeId=5efb1469152a4, content=<a href='/topic/show?id=211f98250b' target=_blank style='color:#2F92EE;'>#IND#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9825, encryptionId=211f98250b, topicName=IND)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=16377007930, createdName=xiaogang319, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551466, encodeId=3107155146667, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Feb 01 03:13:00 CST 2020, time=2020-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=378654, encodeId=8fcc3e8654d5, content=多半是先天发育不良, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/11/13/297abc49521542fee373596e497d37fc.jpg, createdBy=db695226500, createdName=1478fa69m73暂无昵称, createdTime=Thu Jan 30 14:06:12 CST 2020, time=2020-01-30, status=1, ipAttribution=)]
    2020-01-30 1478fa69m73暂无昵称

    多半是先天发育不良

    0

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