抗TNF-α单抗皮下制剂Remsima获批,治疗时间缩短至25分钟

2020-08-01 MedSci原创 MedSci原创

欧盟委员会批准Remsima,用于治疗强直性脊柱炎、克罗恩病、溃疡性结肠炎、银屑病关节炎和牛皮癣。

欧盟委员会批准英夫利昔单抗(infliximab)的全球首个皮下制剂Remsima,用于另外五种适应症,包括强直性脊柱炎(AS),克罗恩病(CD),溃疡性结肠炎(UC),银屑病关节炎(PsA)和牛皮癣(PsO)。

图片来源:https://news.pharmacodia.com/

英夫利昔单抗是针对肿瘤坏死因子(TNF-α)的人鼠嵌合单抗,皮下制剂可以由患者自己给药,将治疗时间减少到大约二十五分钟,功效和安全性与该药物的静脉制剂相当。

这项批准是在6月份获得欧洲药品管理局人用药物委员会的肯定意见后进行的,基于一项关键性研究的数据,该数据比较了Remsima的皮下和静脉制剂用于活动性克罗恩病和溃疡性结肠炎患者一年的药代动力学、功效和安全性参数。

图片来源:Abstracts of the 15th Congress of ECCO – European Crohn’s and Colitis Organisation

德国Stefan Schreiber教授表示:“ Remsima的批准标志着胃肠病领域的一项重要进展,这意味着患者可以在更短的时间内进行治疗,提供了更大的灵活性,并改变了治疗方式。”

原始出处:

http://www.pharmatimes.com/news/ec_approves_subcutaneous_version_of_remsima_1345761

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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1741289, encodeId=53151e412897e, content=<a href='/topic/show?id=90a8153154e' target=_blank style='color:#2F92EE;'>#Remsima#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15315, encryptionId=90a8153154e, topicName=Remsima)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1d4b34912229, createdName=ms9203727104890838, createdTime=Sun Jan 10 09:22:42 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401777, encodeId=39281401e77dc, content=<a href='/topic/show?id=17e21e57943' target=_blank style='color:#2F92EE;'>#TNF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17579, encryptionId=17e21e57943, topicName=TNF)], attachment=null, 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  5. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1741289, encodeId=53151e412897e, content=<a href='/topic/show?id=90a8153154e' target=_blank style='color:#2F92EE;'>#Remsima#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15315, encryptionId=90a8153154e, topicName=Remsima)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1d4b34912229, createdName=ms9203727104890838, createdTime=Sun Jan 10 09:22:42 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401777, encodeId=39281401e77dc, content=<a href='/topic/show?id=17e21e57943' target=_blank style='color:#2F92EE;'>#TNF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17579, encryptionId=17e21e57943, topicName=TNF)], attachment=null, 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level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Sat Aug 01 16:50:25 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2021-01-30 mfx808
  6. 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  7. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1741289, encodeId=53151e412897e, content=<a href='/topic/show?id=90a8153154e' target=_blank style='color:#2F92EE;'>#Remsima#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15315, encryptionId=90a8153154e, topicName=Remsima)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1d4b34912229, createdName=ms9203727104890838, createdTime=Sun Jan 10 09:22:42 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401777, encodeId=39281401e77dc, content=<a href='/topic/show?id=17e21e57943' target=_blank style='color:#2F92EE;'>#TNF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17579, encryptionId=17e21e57943, topicName=TNF)], attachment=null, 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level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Sat Aug 01 16:50:25 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2020-08-03 snowpeakxu
  8. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1741289, encodeId=53151e412897e, content=<a href='/topic/show?id=90a8153154e' target=_blank style='color:#2F92EE;'>#Remsima#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15315, encryptionId=90a8153154e, topicName=Remsima)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1d4b34912229, createdName=ms9203727104890838, createdTime=Sun Jan 10 09:22:42 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401777, encodeId=39281401e77dc, content=<a href='/topic/show?id=17e21e57943' target=_blank style='color:#2F92EE;'>#TNF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17579, encryptionId=17e21e57943, topicName=TNF)], attachment=null, 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level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Sat Aug 01 16:50:25 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2020-08-03 小几洁
  9. 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level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Sat Aug 01 16:50:25 CST 2020, time=2020-08-01, status=1, ipAttribution=)]
    2020-08-01 飞翔的乌龟

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