欧洲药品管理局批准了Diurnal的皮质醇替代品Chronocort的监管路径,治疗先天性肾上腺增生

2019-04-12 不详 MedSci原创

欧洲药品管理局(EMA)批准了Diurnal公司的皮质醇替代产品Chronocort,治疗先天性肾上腺增生(CAH)的临床和监管途径,此批准意味着该公司有望在2019年第四季度提交营销授权申请。

欧洲药品管理局(EMA)批准了Diurnal公司的皮质醇替代产品Chronocort,治疗先天性肾上腺增生(CAH)的临床和监管途径,此批准意味着该公司有望在2019年第四季度提交营销授权申请。

氢化可的松改良释放制剂被设计成模拟皮质醇的昼夜节律,每天给药两次,即一次在早晨和一次在晚上。这有助于控制皮质醇缺乏症患者的雄激素过剩和慢性疲劳。

该药已完成四项I期试验,2014年在美国16名CAH患者进行II期试验,并在欧洲122名CAH患者进行III期试验。尽管有消息称其实验性治疗的后期研究未能达到其主要目标,该公司的股价也因此暴跌超过50%。

在欧洲,Chronocort已被授予孤儿药品指定治疗CAH,如果一旦上市被许可,将获得10年的市场独家经营权。

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    2019-04-29 一天没事干

    很好的学习机会

    0

  4. 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  5. 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  6. 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  7. 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target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Sun Apr 14 11:42:00 CST 2019, time=2019-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1369436, encodeId=182b136943619, content=<a href='/topic/show?id=bc9f28589d0' target=_blank style='color:#2F92EE;'>#先天性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28589, encryptionId=bc9f28589d0, topicName=先天性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a435298, createdName=huirong, createdTime=Sun Apr 14 11:42:00 CST 2019, time=2019-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1371631, encodeId=96ea13e1631e4, content=<a href='/topic/show?id=bf1ce2339d0' target=_blank style='color:#2F92EE;'>#监管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72339, encryptionId=bf1ce2339d0, topicName=监管)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b96f328, createdName=wwzzly, createdTime=Sun Apr 14 11:42:00 CST 2019, time=2019-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425441, encodeId=783f142544141, content=<a href='/topic/show?id=b602630980d' target=_blank style='color:#2F92EE;'>#欧洲药品管理局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63098, encryptionId=b602630980d, topicName=欧洲药品管理局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c44f3972955, createdName=isabellayj, createdTime=Sun Apr 14 11:42:00 CST 2019, time=2019-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1659386, encodeId=073016593868b, content=<a href='/topic/show?id=7f998e468c2' target=_blank style='color:#2F92EE;'>#药品管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=15, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87468, encryptionId=7f998e468c2, topicName=药品管理)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=232724968866, createdName=pcw114, createdTime=Tue Jul 30 11:42:00 CST 2019, time=2019-07-30, status=1, ipAttribution=)]
    2019-04-14 huirong
  8. 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target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Sun Apr 14 11:42:00 CST 2019, time=2019-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1369436, encodeId=182b136943619, content=<a href='/topic/show?id=bc9f28589d0' target=_blank style='color:#2F92EE;'>#先天性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28589, encryptionId=bc9f28589d0, topicName=先天性)], attachment=null, authenticateStatus=null, createdAvatar=, 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encryptionId=b602630980d, topicName=欧洲药品管理局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c44f3972955, createdName=isabellayj, createdTime=Sun Apr 14 11:42:00 CST 2019, time=2019-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1659386, encodeId=073016593868b, content=<a href='/topic/show?id=7f998e468c2' target=_blank style='color:#2F92EE;'>#药品管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=15, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87468, encryptionId=7f998e468c2, topicName=药品管理)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=232724968866, createdName=pcw114, createdTime=Tue Jul 30 11:42:00 CST 2019, time=2019-07-30, status=1, ipAttribution=)]
    2019-04-14 wwzzly
  9. 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  10. 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