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诺华单抗Cosentyx将于2015年初上市,将成为IL-17阻断剂

2014-11-26 佚名 生物谷

诺华(Novartis)近日宣布,单抗药物Cosentyx(secukinumab)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP已建议批准secukinumab作为一线系统性疗法,用于中度至重度斑块型银屑病(plaque psoriasis)成人患者的治疗(相关阅读:诺华公司抗炎症药物secukinumab治疗银屑性关节炎取得重大突破)。在美国,FDA皮肤科和眼

诺华(Novartis)近日宣布,单抗药物Cosentyx(secukinumab)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP已建议批准secukinumab作为一线系统性疗法,用于中度至重度斑块型银屑病(plaque psoriasis)成人患者的治疗(相关阅读:诺华公司抗炎症药物secukinumab治疗银屑性关节炎取得重大突破)。在美国,FDA皮肤科和眼科药物顾问委员会(DODAC)于今年10月一致建议批准secukinumab。

欧盟委员会(EC)预计将在2个月内做出最终审查决定。在欧洲,目前所有治疗银屑病的生物制剂(包括抗肿瘤坏死因子疗法(anti-TNFs)及ustekinumab),均被推荐作为二线系统性疗法。此次CHMP的积极意见,意味着医生可以使用secukinumab取代其他具有显著副作用的一线系统疗法,用于银屑病患者的一线治疗。

如果获批,secukinumab将成为市面上首个IL-17阻断剂药物。目前,银屑病市场由TNF阻断剂(抗肿瘤坏死因子单抗)统治,然而有高达40%的患者对TNF阻断剂治疗不足或无反应。而IL-17阻断剂的上市,将极大地改善银屑病、银屑病关节炎及其他炎症性疾病的临床标准护理。

有分析师认为,尽管诺华secukinumab很可能是上市的首个IL-17阻断剂,但该市场将很快迎来其他竞争产品。紧跟secukinumab之后的是安进和阿斯利康开发的类似药物brodalumab,该药在银屑病和银屑病关节炎III期临床中均创下了骄人的成绩。此外,礼来的IL-17阻断剂ixekizumab目前已进入III期临床,默沙东的MK-3222和强生(JNJ)的IL-23阻断剂guselkumab也将于本季度进入III期临床开发。

目前,诺华正在调查secukinumab用于多种炎症疾病的治疗,包括银屑病、银屑病关节炎、强直性脊柱炎(AS)和类风湿性关节炎(RA)。业界预测,如果这4个适应症均获批,secukinumab到2020年的销售额将突破10亿美元。

今年10月,secukinumab在强直性脊柱炎(AS)2个关键III期研究(MEASURE-1,MEASURE-2)获得成功(相关阅读:诺华单抗secukinumab强直性脊柱炎III期临床大获成功),研究中secukinumab显著改善了疾病的症状和体征,同时也显著改善了患者的身体机能和生活质量。该研究成果也标志着secukinumab成为首个在强直性脊柱炎(AS)III期临床获得成功的IL-17A阻断剂。这2项研究中,secukinumab的安全性与该药在银屑病大型III期项目中的安全性一致。诺华已计划在2015年提交secukinumab治疗银屑病关节炎(PsA)和强直性脊柱炎(AS)的监管申请。

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    2014-11-28 fzwish20000
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  6. [GetPortalCommentsPageByObjectIdResponse(id=1709997, encodeId=92ec1e09997e2, content=<a href='/topic/show?id=7ac59e67604' target=_blank style='color:#2F92EE;'>#阻断#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97676, encryptionId=7ac59e67604, topicName=阻断)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b5ca31824852, createdName=41514497@qq.com, createdTime=Sun Nov 30 11:23:00 CST 2014, time=2014-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1816418, encodeId=fede181641833, content=<a href='/topic/show?id=08049e6803b' target=_blank style='color:#2F92EE;'>#阻断剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97680, encryptionId=08049e6803b, topicName=阻断剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32a12500167, createdName=12498ca5m83暂无昵称, createdTime=Sun Sep 20 20:23:00 CST 2015, time=2015-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282639, encodeId=6aa01282639c3, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Fri Nov 28 00:23:00 CST 2014, time=2014-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1374401, encodeId=0e0b13e440150, content=<a href='/topic/show?id=1727963861' target=_blank style='color:#2F92EE;'>#IL-17#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9638, encryptionId=1727963861, topicName=IL-17)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bcaa382, createdName=fzwish20000, createdTime=Fri Nov 28 00:23:00 CST 2014, time=2014-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1508112, encodeId=f789150811208, content=<a href='/topic/show?id=8b7751152d' target=_blank style='color:#2F92EE;'>#Cosentyx#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5115, encryptionId=8b7751152d, topicName=Cosentyx)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=79929938099, createdName=isabellayj, createdTime=Fri Nov 28 00:23:00 CST 2014, time=2014-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1508167, encodeId=bf78150816e62, content=<a href='/topic/show?id=8d4596248e' target=_blank style='color:#2F92EE;'>#IL-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9624, encryptionId=8d4596248e, topicName=IL-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f6cf9946833, createdName=jjjiang0202, createdTime=Fri Nov 28 00:23:00 CST 2014, time=2014-11-28, status=1, ipAttribution=)]
    2014-11-28 jjjiang0202
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