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5.9万美元/年！艾伯维官宣JAK抑制剂Rinvoq定价，8月底登陆美国！

2019-08-21 sinayiyao 医药第一时间

抗炎新药RinvoqFDA
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上周五，艾伯维备受业界关注的JAK1抑制剂类抗炎新药Rinvoq（upadacitinib）获得美国FDA批准，用于对甲氨蝶呤应答不足或不耐受（MTX-IR）的中度至重度活动性类风湿性关节炎（RA）成人患者的治疗。Rinvoq通过口服给药，推荐剂量为每日一次15mg，可作为单药疗法，也可与MTX或其他非生物类疾病修饰抗风湿药物（DMARD）联合用药，该药不适用于未接受过MTX治疗的患者。

上周五，艾伯维备受业界关注的JAK1抑制剂类抗炎新药Rinvoq（upadacitinib）获得美国FDA批准，用于对甲氨蝶呤应答不足或不耐受（MTX-IR）的中度至重度活动性类风湿性关节炎（RA）成人患者的治疗。Rinvoq通过口服给药，推荐剂量为每日一次15mg，可作为单药疗法，也可与MTX或其他非生物类疾病修饰抗风湿药物（DMARD）联合用药，该药不适用于未接受过MTX治疗的患者。

日前，艾伯维公布了Rinvoq定价，年治疗费用为5.9万美元，与品修美乐（Humira）价格接近，后者需要定期注射，年治疗费用为6万美元。临床数据显示，Rinvoq在治疗中重度RA方面比Humira更有效。

FDA对Rinvoq的批准，是基于III期临床项目SELECT的数据，该项目是在RA领域开展的最大规模的注册III期项目之一，共有约4400例患者在5项研究中接受了治疗。项目评估了Rinvoq治疗各种类型RA患者的疗效、安全性和耐受性，包括生物类疾病修饰抗风湿药物（包括TNF抑制剂，如Humira）治疗失败或不耐受的患者、未接受过MTX治疗或对MTX治疗应答不足的患者。在5项研究中，Rinvoq均达到了主要终点和次要终点。

Rinvoq不是第一个对TNF抑制剂发起挑战的JAK抑制剂，却是第一个拥有数据明确显示在多个终点上表现出优越性的JAK抑制剂。艾伯维预计，Rinvoq将在8月底进入美国市场，该药将与辉瑞Xeljanz和礼来Olumiant展开竞争，这两个药物均已被FDA批准治疗RA。

值得注意的是，上个月，FDA在Xeljanz的药物标签上增加了一则黑框警告，提示增加的潜在致命性血栓风险。此外，Olumiant也因为安全性问题仅被FDA批准了2mg低剂量，4mg剂量被拒绝批准，其药物标签中也存在严重感染、癌症和血栓的警告信息。Rinvoq同样未能幸免，在药物标签中也存在血栓风险警告信息。但艾伯维认为，Rinvoq的副作用是可以识别和控制的，不会对销售形成障碍。

Rinvoq是继Skyrizi后艾伯维在今年获美国FDA批准的第二款免疫调节剂疗法。这两款产品被认为是公司支撑“后修美乐时代”业绩的关键产品，将帮助抵消阿达木单抗生物仿制药进入美国市场（目前预计在2023年）后导致的Humira销售预期下降。其中，Skyrizi是一款靶向抑制IL-23的单克隆抗体药物，于今年4月获批治疗中重度斑块型银屑病。

根据科睿唯安最近的一项分析，Rinvoq在2023年的销售额预计将超20亿美元，这一数字领先于Olumiant但落后于Xeljanz，后者同时期的销售额预计在33亿美元。科睿唯安还预测，Skyrizi在同时期的销售额将达到17亿美元。

在JAK抑制剂类别中，未来的竞争将日益激烈。吉利德和Galapagos的JAK抑制剂filgotinib正在等待欧洲药品管理局的审查决定，双方计划在年底前提交美国上市申请。同时，辉瑞正在开发Xeljanz的升级版产品abrocitinib，这是新一代JAK抑制剂，已被FDA授予突破性药物资格，被认为可避开JAK抑制剂类药物普遍存在的血栓问题。

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    2020-06-13 肉我只吃一口

    #JAK#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1738011, encodeId=40201e3801153, content=<a href='/topic/show?id=0abd10215e0' target=_blank style='color:#2F92EE;'>#JAK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10215, encryptionId=0abd10215e0, topicName=JAK)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e8634348903, createdName=肉我只吃一口, createdTime=Sat Jun 13 14:17:00 CST 2020, time=2020-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675185, encodeId=727416e51858f, content=<a href='/topic/show?id=dcf4154883a' target=_blank style='color:#2F92EE;'>#Rinvoq#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15488, encryptionId=dcf4154883a, topicName=Rinvoq)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ae2827174135, createdName=fanweitanzhen, createdTime=Mon Mar 30 10:17:00 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852102, encodeId=9630185210219, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sat May 16 08:17:00 CST 2020, time=2020-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1350222, encodeId=c4671350222c3, content=<a href='/topic/show?id=bc1086e4652' target=_blank style='color:#2F92EE;'>#艾伯维#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86746, encryptionId=bc1086e4652, topicName=艾伯维)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Aug 23 13:17:00 CST 2019, time=2019-08-23, status=1, ipAttribution=)]
    2020-03-30 fanweitanzhen

    #Rinvoq#

    0

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    2020-05-16 jklm09

    #抑制剂#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1738011, encodeId=40201e3801153, content=<a href='/topic/show?id=0abd10215e0' target=_blank style='color:#2F92EE;'>#JAK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10215, encryptionId=0abd10215e0, topicName=JAK)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e8634348903, createdName=肉我只吃一口, createdTime=Sat Jun 13 14:17:00 CST 2020, time=2020-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675185, encodeId=727416e51858f, content=<a href='/topic/show?id=dcf4154883a' target=_blank style='color:#2F92EE;'>#Rinvoq#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15488, encryptionId=dcf4154883a, topicName=Rinvoq)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ae2827174135, createdName=fanweitanzhen, createdTime=Mon Mar 30 10:17:00 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852102, encodeId=9630185210219, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sat May 16 08:17:00 CST 2020, time=2020-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1350222, encodeId=c4671350222c3, content=<a href='/topic/show?id=bc1086e4652' target=_blank style='color:#2F92EE;'>#艾伯维#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86746, encryptionId=bc1086e4652, topicName=艾伯维)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Aug 23 13:17:00 CST 2019, time=2019-08-23, status=1, ipAttribution=)]
    2019-08-23 zhaojie88

    #艾伯维#

    0