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FDA批准也是**一个多发性硬化症患者自行注射的B细胞疗法Kesimpta(ofatumumab),只需每月注射一次

2020-08-21 MedSci原创 MedSci原创

Kesimpta是全人源抗CD20单抗,与特立氟胺相比,显示出优异的疗效和相似的安全性。

诺华公司宣布,美国食品和药物管理局(FDA)已批准Kesimpta(奥法木单抗,ofatumumab)作为一种皮下制剂用于治疗复发型多发性硬化症(RMS),包括临床孤立综合征,复发缓解型和活动性继发进展型。

图片来源:https://www.slideshare.net/ESOSLIDES/2-stathis-10400840

Kesimpta是全人源抗CD20单抗,与特立氟胺相比,显示出优异的疗效和相似的安全性。此次FDA的批准,使得Kesimpta成为第一种也是唯一一种患者可以在家自行注射治疗的B细胞疗法,每月一次通过Sensoready自动注射笔注射。

Kesimpta的批准是基于III期临床研究ASCLEPIOS I和II期研究的结果,结果显示Kesimpta显着降低了年复发率(ARR,主要终点)和3个月后的确认残疾进展(CDP)。研究结果于2020年8月6日发表在NEJM杂志上。

Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med 2020;383:546-57. DOI: 10.1056/NEJMoa1917246

Kesimpta通过每月一次皮下注射为患者提供了自我给药的灵活性,无需前往医院输液治疗。II期研究APLIOS研究的阳性结果证明RMS患者通过预装注射器和Sensoready笔皮下注射Kesimpta的生物等效性。

原始出处:

https://www.firstwordpharma.com/node/1750899?tsid=4

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    2021-04-07 snf701207
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    2021-03-21 bugit
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    2020-08-27 14818eb4m67暂无昵称

    学习了

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  8. [GetPortalCommentsPageByObjectIdResponse(id=1983129, encodeId=08ab198312902, 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=95, 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=Wed Feb 17 12:46:23 CST 2021, time=2021-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912433, encodeId=f2d319124332b, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Apr 07 12:46:23 CST 2021, time=2021-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890153, encodeId=7a991890153fb, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=119, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Wed Jun 23 10:46:23 CST 2021, time=2021-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839865, encodeId=993c18398652b, 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=127, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Sun Mar 21 05:46:23 CST 2021, time=2021-03-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2029963, encodeId=2432202996346, content=<a href='/topic/show?id=d493e259c9' target=_blank style='color:#2F92EE;'>#fat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7259, encryptionId=d493e259c9, topicName=fat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=198d2500149, createdName=12498bd5m16暂无昵称, createdTime=Mon Nov 30 17:46:23 CST 2020, time=2020-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=814230, encodeId=b7e68142306e, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=144, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Thu Aug 27 18:46:45 CST 2020, time=2020-08-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1273371, encodeId=687a12e337178, content=<a href='/topic/show?id=310d383ef5' target=_blank style='color:#2F92EE;'>#B细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3837, encryptionId=310d383ef5, topicName=B细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eba113, createdName=xiaoyeshuang, createdTime=Sun Aug 23 04:46:23 CST 2020, time=2020-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588446, encodeId=74df1588446d9, content=<a href='/topic/show?id=1cb8e014e0' target=_blank style='color:#2F92EE;'>#ESI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7014, encryptionId=1cb8e014e0, topicName=ESI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f4f817593223, createdName=skhzy, createdTime=Sun Aug 23 04:46:23 CST 2020, time=2020-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=811745, encodeId=3882811e45fd, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=162, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200820/420b8df5095e4a77b1c8da9d12eb8dc0/cd923b50e7484a2aa9911a449e597eeb.jpg, createdBy=d2c65412208, createdName=丁丁当, createdTime=Fri Aug 21 14:17:19 CST 2020, time=2020-08-21, status=1, ipAttribution=)]
    2020-08-23 skhzy
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    2020-08-21 丁丁当

    学习

    0

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