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FDA批准Shionogi的Mulpleta治疗慢性肝病引起的血小板减少症

2018-08-01 MedSci MedSci原创

美国食品和药物管理局(FDA)近日宣布批准Shionogi的Mulpleta(lusutrombopag)用于治疗慢性肝病引起的成人血小板减少症。FDA于今年2月份接受了血小板生成素受体激动剂Mulpleta的申请,并授予其优先审查资格。

美国食品和药物管理局(FDA)近日宣布批准ShionogiMulpletalusutrombopag)用于治疗慢性肝病引起的成人血小板减少症。FDA于今年2月份接受了血小板生成素受体激动剂Mulpleta的申请,并授予其优先审查资格。

根据FDA的说法,该批准是根据两项临床研究数据得出的,这两项研究被称为L-PLUS 1L-PLUS 2,随机分组了312名患有慢性肝病和严重血小板减少症的患者,这些患者正在接受侵入性手术,每天接受一次Mulpleta或安慰剂治疗。L-PLUS 1的结果显示,78%的接受Mulpleta治疗的患者在初次侵入性治疗前不需要输注血小板,而安慰剂组这一数据仅为13%。同时,在L-PLUS 2中,65%接受Mulpleta治疗的患者在初次侵入性手术或急救治疗时无需血小板输注,而安慰剂组为29%。FDA指出,与该药物有关的最常见的不良反应是头痛。

lusutrombopag的营销申请也正在欧洲进行审查,而该药物(以前称为S-888711)于2015年在日本获得批准用于改善慢性肝病相关的血小板减少症。


原始出处:

http://www.firstwordpharma.com/node/1582248#axzz5Mw2WiygQ

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    2019-01-10 lisa438
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  5. 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    2018-08-03 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

  6. 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    2018-08-02 小小小麦兜

    学习了

    0

  7. 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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Thu Aug 02 08:01:56 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335702, encodeId=61e0335e02a0, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Thu Aug 02 07:59:33 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335688, encodeId=07713356882c, content=血小板生成素受体~mulpleta~学习了~, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d7e71713450, createdName=太阳系小猪, createdTime=Thu Aug 02 07:09:40 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-02 清风拂面

    谢谢分享学习

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=2011740, encodeId=854d2011e405c, content=<a href='/topic/show?id=85f61103863' target=_blank style='color:#2F92EE;'>#LPL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11038, encryptionId=85f61103863, topicName=LPL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=373b263, createdName=lisa438, createdTime=Thu Jan 10 05:03:00 CST 2019, time=2019-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1689173, encodeId=e8e516891e367, content=<a href='/topic/show?id=1f351625ead' target=_blank style='color:#2F92EE;'>#Shionogi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16257, encryptionId=1f351625ead, topicName=Shionogi)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=156c28741842, createdName=ms5106640509429053, createdTime=Sun Oct 21 22:03:00 CST 2018, time=2018-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839610, encodeId=d6bd1839610ba, 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=82, 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=Sat Sep 22 21:03:00 CST 2018, time=2018-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302794, encodeId=56e61302e9473, content=<a href='/topic/show?id=9c72890153c' target=_blank style='color:#2F92EE;'>#血小板减少#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89015, encryptionId=9c72890153c, topicName=血小板减少)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Fri Aug 03 14:03:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335940, encodeId=1f5c33594067, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Aug 03 07:22:43 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335751, encodeId=4667335e51e1, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://login.medsci.cn/upload/avatar/f3d88083d8829740786bed95c22464d1/e325f3af93bb747a620d16c209094d69.jpg, createdBy=9efb2014947, createdName=小小小麦兜, createdTime=Thu Aug 02 10:16:26 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335735, encodeId=ad58335e35b5, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, 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=Thu Aug 02 08:54:21 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335710, encodeId=271f335e104a, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=110, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Thu Aug 02 08:01:56 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335702, encodeId=61e0335e02a0, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Thu Aug 02 07:59:33 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335688, encodeId=07713356882c, content=血小板生成素受体~mulpleta~学习了~, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d7e71713450, createdName=太阳系小猪, createdTime=Thu Aug 02 07:09:40 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-02 龙胆草

    学习谢谢分享

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=2011740, encodeId=854d2011e405c, content=<a href='/topic/show?id=85f61103863' target=_blank style='color:#2F92EE;'>#LPL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11038, encryptionId=85f61103863, topicName=LPL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=373b263, createdName=lisa438, createdTime=Thu Jan 10 05:03:00 CST 2019, time=2019-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1689173, encodeId=e8e516891e367, content=<a href='/topic/show?id=1f351625ead' target=_blank style='color:#2F92EE;'>#Shionogi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16257, encryptionId=1f351625ead, topicName=Shionogi)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=156c28741842, createdName=ms5106640509429053, createdTime=Sun Oct 21 22:03:00 CST 2018, time=2018-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839610, encodeId=d6bd1839610ba, 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=82, 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=Sat Sep 22 21:03:00 CST 2018, time=2018-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302794, encodeId=56e61302e9473, content=<a href='/topic/show?id=9c72890153c' target=_blank style='color:#2F92EE;'>#血小板减少#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89015, encryptionId=9c72890153c, topicName=血小板减少)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Fri Aug 03 14:03:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335940, encodeId=1f5c33594067, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Aug 03 07:22:43 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335751, encodeId=4667335e51e1, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://login.medsci.cn/upload/avatar/f3d88083d8829740786bed95c22464d1/e325f3af93bb747a620d16c209094d69.jpg, createdBy=9efb2014947, createdName=小小小麦兜, createdTime=Thu Aug 02 10:16:26 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335735, encodeId=ad58335e35b5, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, 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=Thu Aug 02 08:54:21 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335710, encodeId=271f335e104a, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=110, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Thu Aug 02 08:01:56 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335702, encodeId=61e0335e02a0, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Thu Aug 02 07:59:33 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335688, encodeId=07713356882c, content=血小板生成素受体~mulpleta~学习了~, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d7e71713450, createdName=太阳系小猪, createdTime=Thu Aug 02 07:09:40 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-02 1ddf0692m34(暂无匿称)

    学习了,谢谢分享

    0

  10. [GetPortalCommentsPageByObjectIdResponse(id=2011740, encodeId=854d2011e405c, content=<a href='/topic/show?id=85f61103863' target=_blank style='color:#2F92EE;'>#LPL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11038, encryptionId=85f61103863, topicName=LPL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=373b263, createdName=lisa438, createdTime=Thu Jan 10 05:03:00 CST 2019, time=2019-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1689173, encodeId=e8e516891e367, content=<a href='/topic/show?id=1f351625ead' target=_blank style='color:#2F92EE;'>#Shionogi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16257, encryptionId=1f351625ead, topicName=Shionogi)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=156c28741842, createdName=ms5106640509429053, createdTime=Sun Oct 21 22:03:00 CST 2018, time=2018-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839610, encodeId=d6bd1839610ba, 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=82, 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=Sat Sep 22 21:03:00 CST 2018, time=2018-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302794, encodeId=56e61302e9473, content=<a href='/topic/show?id=9c72890153c' target=_blank style='color:#2F92EE;'>#血小板减少#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89015, encryptionId=9c72890153c, topicName=血小板减少)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Fri Aug 03 14:03:00 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335940, encodeId=1f5c33594067, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=122, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Aug 03 07:22:43 CST 2018, time=2018-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335751, encodeId=4667335e51e1, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://login.medsci.cn/upload/avatar/f3d88083d8829740786bed95c22464d1/e325f3af93bb747a620d16c209094d69.jpg, createdBy=9efb2014947, createdName=小小小麦兜, createdTime=Thu Aug 02 10:16:26 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335735, encodeId=ad58335e35b5, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, 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=Thu Aug 02 08:54:21 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335710, encodeId=271f335e104a, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=110, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Thu Aug 02 08:01:56 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335702, encodeId=61e0335e02a0, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Thu Aug 02 07:59:33 CST 2018, time=2018-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335688, encodeId=07713356882c, content=血小板生成素受体~mulpleta~学习了~, beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d7e71713450, createdName=太阳系小猪, createdTime=Thu Aug 02 07:09:40 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-02 太阳系小猪

    血小板生成素受体~mulpleta~学习了~

    0

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