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FDA批准nintedanib治疗与系统性硬化症相关的间质性肺病

2019-09-08 Allan MedSci原创

美国FDA周五(2019年9月6日)宣布,批准Boehringer Ingelheim的Ofev(nintedanib)治疗与系统性硬化症相关的间质性肺病(SSc-ILD),用以减慢肺功能的下降速度。该机构指出,Ofev是FDA批准的第一种SSc-ILD治疗方法。

美国FDA周五(201996日)宣布,批准Boehringer IngelheimOfevnintedanib)治疗与系统性硬化症相关的间质性肺病(SSc-ILD),用以减慢肺功能的下降速度。该机构指出,OfevFDA批准的第一种SSc-ILD治疗方法。该批准得到了SENSCIS试验数据的支持,该试验纳入了576例年龄在2079岁之间的SSc-ILD患者。5月份公布的研究数据显示,与安慰剂相比,使用Ofevnintedanib)治疗52周后,肺功能损失减缓了44%。Ofev之前曾获得美国和欧盟的孤儿药物认定,以及FDA的快速指定。


原始出处:

http://www.firstwordpharma.com/node/1664664#axzz5yvEPt24Y

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    2019-10-26 amy0559
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href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, 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 Sep 10 08:14:00 CST 2019, time=2019-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627368, encodeId=63c7162e3681b, content=<a href='/topic/show?id=dbcee69217e' target=_blank style='color:#2F92EE;'>#系统性硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76921, encryptionId=dbcee69217e, topicName=系统性硬化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8cf521117287, createdName=yhy100207, createdTime=Tue Sep 10 08:14:00 CST 2019, time=2019-09-10, status=1, ipAttribution=)]
    2019-10-19 bugit
  5. 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href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, 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 Sep 10 08:14:00 CST 2019, time=2019-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627368, encodeId=63c7162e3681b, content=<a href='/topic/show?id=dbcee69217e' target=_blank style='color:#2F92EE;'>#系统性硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76921, encryptionId=dbcee69217e, topicName=系统性硬化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8cf521117287, createdName=yhy100207, createdTime=Tue Sep 10 08:14:00 CST 2019, time=2019-09-10, status=1, ipAttribution=)]
    2019-12-06 aliceclz
  6. 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time=2019-09-10, status=1, ipAttribution=)]
  7. 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time=2019-09-10, status=1, ipAttribution=)]
  8. 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channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76926, encryptionId=fc0ce69267e, topicName=系统性硬化症相关的间质性肺病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8143398, createdName=lily1616, createdTime=Thu Jun 25 17:14:00 CST 2020, time=2020-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1983079, encodeId=494f19830e90e, 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=64, 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 Sep 24 12:14:00 CST 2019, time=2019-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361792, encodeId=3dfd1361e9295, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, 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 Sep 10 08:14:00 CST 2019, time=2019-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627368, encodeId=63c7162e3681b, content=<a href='/topic/show?id=dbcee69217e' target=_blank style='color:#2F92EE;'>#系统性硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76921, encryptionId=dbcee69217e, topicName=系统性硬化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8cf521117287, createdName=yhy100207, createdTime=Tue Sep 10 08:14:00 CST 2019, time=2019-09-10, status=1, ipAttribution=)]
  9. 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