Nintedanib治疗系统性硬化症相关性间质性肺病:已获得CHMP的积极评价

2020-03-01 Allan MedSci原创

勃林格殷格翰(Boehringer Ingelheim)近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)建议授予Nintedanib上市许可,以治疗硬化症相关性间质性肺病(SSc-ILD)。

勃林格殷格翰(Boehringer Ingelheim)近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)建议授予Nintedanib上市许可,以治疗硬化症相关性间质性肺病(SSc-ILD)。20199月,美国FDA批准Nintedanib用于减缓SSc-ILD患者肺功能下降速度,其他国家(包括加拿大、日本和巴西)也相继批准了Nintedanib治疗SSc-ILD的申请。

系统性硬化症(SSc),也称为硬皮病,是一种致残性和致命性罕见自身免疫疾病。它会引起包括肺、心脏、消化道和肾脏在内的各种器官的纤维化,有危及生命的并发症。当SSc影响肺部时,会引起间质性肺病(ILD),称为SSc-ILDILDSSc死亡的主要原因,几乎占SSc相关死亡的35%。勃林格殷格翰高级副总裁兼治疗区域负责人Peter Fang说:一旦肺发生纤维化,就无法逆转,这可能对患者的日常活动造成毁灭性影响


原始出处:

https://www.firstwordpharma.com/node/1704344

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    2020-12-13 amy0559
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createdName=30397604, createdTime=Tue Mar 24 07:47:00 CST 2020, time=2020-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1671946, encodeId=09c616e194685, content=<a href='/topic/show?id=58378220131' target=_blank style='color:#2F92EE;'>#肺病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, 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=Sun Dec 13 16:47:00 CST 2020, time=2020-12-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1837801, encodeId=01a2183e8015b, content=<a href='/topic/show?id=3f34e253206' target=_blank style='color:#2F92EE;'>#相关性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72532, 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CST 2020, time=2020-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302677, encodeId=9e2c13026e7d7, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361797, encodeId=b5a21361e9714, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12808, encryptionId=131d12808f9, topicName=Nintedanib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce68183, createdName=xiongke010, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444615, encodeId=ddab144461564, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=2017205, encodeId=cb86201e2059e, content=<a href='/topic/show?id=9760e69058c' target=_blank style='color:#2F92EE;'>#系统性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76905, encryptionId=9760e69058c, topicName=系统性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2b9b368, createdName=qingrejiedu, createdTime=Sat Mar 07 14:47:00 CST 2020, time=2020-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983100, encodeId=a7f719831009f, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Tue Mar 24 07:47:00 CST 2020, time=2020-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1671946, encodeId=09c616e194685, content=<a href='/topic/show?id=58378220131' target=_blank style='color:#2F92EE;'>#肺病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, 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=Sun Dec 13 16:47:00 CST 2020, time=2020-12-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1837801, encodeId=01a2183e8015b, content=<a href='/topic/show?id=3f34e253206' target=_blank style='color:#2F92EE;'>#相关性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72532, 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channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75125, encryptionId=57a7e5125ec, topicName=积极评价)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqPdWFricgmt6Dde2ptNxJzD6Y9c4cxpXdTo4pNlVPARAnFdKu6nWIPele9icxApTaFgibq0uVlgRiceQ/132, createdBy=4b8c2500026, createdName=ms8435843352634314, createdTime=Fri Jul 03 05:47:00 CST 2020, time=2020-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1815816, encodeId=88391815816b4, content=<a href='/topic/show?id=82e99e291b0' target=_blank style='color:#2F92EE;'>#间质性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97291, encryptionId=82e99e291b0, topicName=间质性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=99cf2500102, createdName=zjshifan_98647306, createdTime=Sat Apr 11 17:47:00 CST 2020, time=2020-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302677, encodeId=9e2c13026e7d7, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361797, encodeId=b5a21361e9714, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12808, encryptionId=131d12808f9, topicName=Nintedanib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce68183, createdName=xiongke010, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444615, encodeId=ddab144461564, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=)]
    2020-08-18 aliceclz
  6. [GetPortalCommentsPageByObjectIdResponse(id=2017205, encodeId=cb86201e2059e, content=<a href='/topic/show?id=9760e69058c' target=_blank style='color:#2F92EE;'>#系统性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76905, encryptionId=9760e69058c, topicName=系统性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2b9b368, createdName=qingrejiedu, createdTime=Sat Mar 07 14:47:00 CST 2020, time=2020-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983100, encodeId=a7f719831009f, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, 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  7. 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CST 2020, time=2020-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302677, encodeId=9e2c13026e7d7, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361797, encodeId=b5a21361e9714, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12808, encryptionId=131d12808f9, topicName=Nintedanib)], attachment=null, 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  8. [GetPortalCommentsPageByObjectIdResponse(id=2017205, encodeId=cb86201e2059e, content=<a href='/topic/show?id=9760e69058c' target=_blank style='color:#2F92EE;'>#系统性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76905, encryptionId=9760e69058c, topicName=系统性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2b9b368, createdName=qingrejiedu, createdTime=Sat Mar 07 14:47:00 CST 2020, time=2020-03-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983100, encodeId=a7f719831009f, content=<a href='/topic/show?id=a7a7e359478' target=_blank style='color:#2F92EE;'>#硬化症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73594, encryptionId=a7a7e359478, topicName=硬化症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, 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CST 2020, time=2020-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302677, encodeId=9e2c13026e7d7, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361797, encodeId=b5a21361e9714, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12808, encryptionId=131d12808f9, topicName=Nintedanib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce68183, createdName=xiongke010, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444615, encodeId=ddab144461564, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=)]
    2020-03-03 医生2394
  9. 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  10. 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authenticateStatus=null, createdAvatar=, createdBy=ce68183, createdName=xiongke010, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444615, encodeId=ddab144461564, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Tue Mar 03 04:47:00 CST 2020, time=2020-03-03, status=1, ipAttribution=)]
    2020-03-03 huagfeg

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欧洲药品管理局的CHMP支持诺和诺德口服GLP-1受体激动剂Rybelsus,用于治疗2型糖尿病

诺和诺德(Novo Nordisk)宣布,欧洲药品管理局的人用药品管理委员会(CHMP)采纳了一项积极意见,建议批准其口服GLP-1受体激动剂Rybelsus(semaglutide)用于治疗2型糖尿病控制不佳的成年人,作为饮食和运动的辅助手段来改善血糖控制。监管机构指出,该药物是开发用于口服的首个GLP-1受体激动剂治疗药物。

Emergent BioSolutions的口服霍乱疫苗Vaxchora,获得欧洲人用药品委员会(CHMP)的正面评价,有望近期获批

Emergent BioSolutions公司宣布其单剂量口服霍乱疫苗Vaxchora,获得欧洲药品管理局(EMA)的人用药品委员会(CHMP)的积极审批意见。预计将在收到积极意见后的三个月内获得欧盟委员会的营销授权决定。

Alnylam的RNA干扰药物Givlaari作为欧盟首例治疗急性肝卟啉症的药物,获得了CHMP的积极评价

Alnylam Pharmaceuticals的RNAi治疗药物Givlaari(givosiran),获得欧洲药品管理局的人用药品管理委员会(CHMP)的积极意见,用于治疗12岁以上的成人和青少年的急性肝卟啉症(AHP)。监管机构表示,如果Alnylam的申请得到批准,该靶向氨基乙酰丙酸合酶1的RNAi药物将成为欧盟中针对AHP的首个治疗药物。

欧洲CHMP持正面意见:KALYDECO(ivacaftor)治疗囊性纤维化婴儿

Vertex制药公司近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)对KALYDECO®(ivacaftor)持肯定态度。

2019年10月14-17日,欧洲人用药物委员会(CHMP)建议批准七种新药上市

EMA的人用药物委员会(CHMP)在其2019年10月的会议上推荐了七种药物以供批准上市。

欧洲药品管理局CHMP建议批准7种药物上市和2种药物扩展适应症

欧洲药品管理局的人类用药产品委员会(CHMP)在11月的会议上,建议批准7种药物以及2种药物的扩展。