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美国FDA接受了Upadacitinib治疗中度至重度类风湿性关节炎的优先审查新药申请

2019-02-23 不详 网络

upadacitinib类风湿性关节炎优先审查新药申请
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AbbVie是一家以研究为基础的全球生物制药公司，已宣布美国食品和药品监督管理局（FDA）已接受Upadacitinib治疗中度至重度类风湿性关节炎的优先审查新药申请（NDA）。

AbbVie是一家以研究为基础的全球生物制药公司，已宣布美国食品和药品监督管理局（FDA）已接受Upadacitinib治疗中度至重度类风湿性关节炎的优先审查新药申请（NDA）。Upadacitinib是一种研究性的每日一次口服JAK1选择性抑制剂，用于治疗多种免疫介导的疾病。

此次NDA的获得得益于全球SELECT III期类风湿性关节炎计划的数据支持，该计划在6项III期研究中中评估了4,000多名患有中度至重度类风湿性关节炎的患者。在所有SELECT III期研究中，Upadacitinib满足所有主要和次要终点。评估疗效的关键指标包括ACR反应、疾病活动评分（DAS28-CRP）和放射学进展的抑制。最常见的严重不良事件是感染，这些临床研究的最终结果先前已公布。Upadacitinib也正在接受欧洲药品管理局的审查，用于治疗患有中度至重度类风湿性关节炎的成年患者。

关于这些试验的更多信息可以在www.clinicaltrials.gov（NCT02706847，NCT03086343，NCT02629159，NCT02706873，NCT02706951，NCT02675426）中找到。


原始出处：

http://www.firstwordpharma.com/node/1625934#axzz5g3U8qmyP

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    2019-12-14 12498877m109暂无昵称

    #CIT#

    0

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    2020-02-08 wangbingxhy

    #新药申请#

    0

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    2019-09-26 liuyong2980

    #中度至重度#

    0

  4. 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topicName=风湿性关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c237911872, createdName=ms1467340776200723, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551427, encodeId=985f155142e6e, 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=29, 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=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=)]
    2019-03-06 zwjnj2

    学习学习

    0

  5. 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topicName=风湿性关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c237911872, createdName=ms1467340776200723, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551427, encodeId=985f155142e6e, 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=29, 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=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=)]
    2019-02-25 般若傻瓜

    #ADA#

    0

  6. 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topicName=风湿性关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c237911872, createdName=ms1467340776200723, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551427, encodeId=985f155142e6e, 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=29, 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=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=)]
    2019-02-25 lmm397

    #关节炎#

    0

  7. 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createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400129, encodeId=21f21400129a0, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483580, encodeId=6efc14835800e, content=<a href='/topic/show?id=55a6100826cc' target=_blank style='color:#2F92EE;'>#风湿性关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100826, encryptionId=55a6100826cc, topicName=风湿性关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c237911872, createdName=ms1467340776200723, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551427, encodeId=985f155142e6e, 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=29, 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=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=)]
    2019-02-25 ms4964546379600229

    #类风湿#

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1738542, encodeId=afb31e3854240, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eabf34462441, createdName=12498877m109暂无昵称, createdTime=Sat Dec 14 04:26:00 CST 2019, time=2019-12-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1744180, encodeId=44691e44180df, content=<a href='/topic/show?id=657a58646ca' target=_blank style='color:#2F92EE;'>#新药申请#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58646, encryptionId=657a58646ca, topicName=新药申请)], attachment=null, authenticateStatus=null, createdAvatar=null, 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createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400129, encodeId=21f21400129a0, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483580, encodeId=6efc14835800e, content=<a href='/topic/show?id=55a6100826cc' target=_blank style='color:#2F92EE;'>#风湿性关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100826, encryptionId=55a6100826cc, topicName=风湿性关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c237911872, createdName=ms1467340776200723, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551427, encodeId=985f155142e6e, 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=29, 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=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=)]
    2019-02-25 yxch37

    #优先审查#

    0

  9. 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topicName=风湿性关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5c237911872, createdName=ms1467340776200723, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551427, encodeId=985f155142e6e, 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=29, 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=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=)]
    2019-02-25 ms1467340776200723

    #风湿性关节炎#

    0

  10. 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createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400129, encodeId=21f21400129a0, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Mon Feb 25 03:26:00 CST 2019, time=2019-02-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483580, encodeId=6efc14835800e, content=<a href='/topic/show?id=55a6100826cc' target=_blank style='color:#2F92EE;'>#风湿性关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100826, encryptionId=55a6100826cc, 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    2019-02-25 10518098zz

    #美国FDA#

    0

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