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Shire的lanadelumab获欧盟快速审查

2018-03-01 MedSci MedSci原创

lanadelumab欧盟快速审查
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欧洲监管机构将对Shire的遗传性血管瘤药物lanadelumab进行加速评估。该公司正在开发lanadelumab用于预防12岁及以上病症的患者发生血管性水肿。HAE是一种罕见的遗传性疾病，会导致身体虚弱，疼痛甚至威胁生命的肿胀，全球患病率约为1/10，p000到1/50，000。Lanadelumab是一种研究性完全人源单克隆抗体，其特异性结合并抑制血浆激肽释放酶，因此可能提供新的治疗方法。该

欧洲监管机构将对Shire的遗传性血管瘤药物lanadelumab进行加速评估。该公司正在开发lanadelumab用于预防12岁及以上病症的患者发生血管性水肿。HAE是一种罕见的遗传性疾病，会导致身体虚弱，疼痛甚至威胁生命的肿胀，全球患病率约为1/10，p000到1/50，000。Lanadelumab是一种研究性完全人源单克隆抗体，其特异性结合并抑制血浆激肽释放酶，因此可能提供新的治疗方法。该报告是根据关键III期HELP研究的数据，该研究显示每两周皮下注射300mg lanadelumab可使HAE发作的平均发生率降低87％。此外，一个探索性的终点显示，在试验的稳态阶段(第70-182天)，10名患者中有8人达到了攻击自由状态，攻击减少了91%。该终点仍需进一步的验证性研究。在本研究中，未报告与治疗有关的严重不良事件或死亡，观察到的最常见副作用是注射部位疼痛（安慰剂组为29.3％，而lanadelumab组为42.9％）。在欧洲中央集权的程序下进行的加速评估在150天内完成，而不是正常的210天。该药物在美国也得到了优先审查。原文出处：http：//www.pharmatimes

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    2018-10-23 liuli5088

    #Shire#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1675166, encodeId=fc9a16e516655, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Tue Oct 23 08:10:00 CST 2018, time=2018-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911947, encodeId=066d191194e0c, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Mar 28 04:10:00 CST 2018, time=2018-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1633454, encodeId=0b6416334549b, content=<a href='/topic/show?id=377824e1c0' target=_blank style='color:#2F92EE;'>#ANA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2471, encryptionId=377824e1c0, topicName=ANA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=434d22047430, createdName=AspirantSuo, createdTime=Fri Nov 02 02:10:00 CST 2018, time=2018-11-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598494, encodeId=2d771598494e3, content=<a href='/topic/show?id=829b124e643' target=_blank style='color:#2F92EE;'>#NAD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12476, encryptionId=829b124e643, topicName=NAD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1b0018615070, createdName=pandamao2016, createdTime=Sat Mar 03 07:10:00 CST 2018, time=2018-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=292028, encodeId=add329202846, content=学习了.涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, 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 Mar 01 16:51:41 CST 2018, time=2018-03-01, status=1, ipAttribution=)]
    2018-03-28 snf701207

    #mAb#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1675166, encodeId=fc9a16e516655, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Tue Oct 23 08:10:00 CST 2018, time=2018-10-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911947, encodeId=066d191194e0c, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Mar 28 04:10:00 CST 2018, time=2018-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1633454, encodeId=0b6416334549b, content=<a href='/topic/show?id=377824e1c0' target=_blank style='color:#2F92EE;'>#ANA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2471, encryptionId=377824e1c0, topicName=ANA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=434d22047430, createdName=AspirantSuo, createdTime=Fri Nov 02 02:10:00 CST 2018, time=2018-11-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598494, encodeId=2d771598494e3, content=<a href='/topic/show?id=829b124e643' target=_blank style='color:#2F92EE;'>#NAD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12476, encryptionId=829b124e643, topicName=NAD)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1b0018615070, createdName=pandamao2016, createdTime=Sat Mar 03 07:10:00 CST 2018, time=2018-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=292028, encodeId=add329202846, content=学习了.涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, 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 Mar 01 16:51:41 CST 2018, time=2018-03-01, status=1, ipAttribution=)]
    2018-11-02 AspirantSuo

    #ANA#

    0

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    2018-03-03 pandamao2016

    #NAD#

    0

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    2018-03-01 1ddf0692m34(暂无匿称)

    学习了.涨知识

    0