AbbVie向美国和欧洲药品管理局提交营销申请,将JAK抑制剂Rinvoq用于治疗银屑病关节炎

2020-06-04 网络 网络

Rinvoq是一种选择性且可逆的JAK抑制剂,正在多种免疫介导的炎症性疾病中进行研究。

艾伯维(AbbVie)向美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)提交了其JAK抑制剂Rinvoq(upadacitinib)新适应症的营销申请,用于治疗活动性银屑病关节炎的成人患者。

这是基于两项三期研究的数据,共涉及2000多名患者。

在这两项研究中,与安慰剂相比,Rinvoq在第12周时均达到了ACR20反应的主要终点,并且在第12周时相对于抗肿瘤坏死因子单抗Adalimumab,也达到了非劣效性的目标。

该公司指出,接受Rinvoq治疗患者的身体功能(HAQ-DI)和皮肤症状(PASI 75)也得到了更好的改善。

AbbVie副董事长兼总裁Michael Severino说:“银屑病关节炎是一种复杂的异质性疾病,在多个组织(包括关节和皮肤)中均有症状,导致疼痛、疲劳和僵硬。”

“我们期待与监管机构合作,希望尽快将Rinvoq带入该类患者。”

Rinvoq是一种选择性且可逆的JAK抑制剂,正在多种免疫介导的炎症性疾病中进行研究。该药物去年被批准用于治疗对一种或多种疾病缓解性抗风湿药反应不佳或不耐受的中度至重度活动性类风湿关节炎成人患者。

原始出处:

http://www.pharmatimes.com/news/abbvie_files_rinvoq_for_psoriatic_arthritis_1341309

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    2020-07-17 jklm09
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09:39:52 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1479600, encodeId=cb1a14e96009f, content=<a href='/topic/show?id=135e1e1794' target=_blank style='color:#2F92EE;'>#Abbvie#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1717, encryptionId=135e1e1794, topicName=Abbvie)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=34847549422, createdName=12498768m15(暂无昵称), createdTime=Sat Jun 06 09:39:52 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=601420, encodeId=af39601420f7, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>JAK抑制剂对重型新冠肺炎有效, beContent=null, objectType=article, channel=null, level=null, likeNumber=337, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1675188, encodeId=2cca16e5188ca, content=<a href='/topic/show?id=dcf4154883a' target=_blank style='color:#2F92EE;'>#Rinvoq#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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=Sun Sep 27 18:39:52 CST 2020, time=2020-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1659420, encodeId=4699165942048, content=<a href='/topic/show?id=7f998e468c2' target=_blank style='color:#2F92EE;'>#药品管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87468, encryptionId=7f998e468c2, topicName=药品管理)], attachment=null, authenticateStatus=null, createdAvatar=, 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09:39:52 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1479600, encodeId=cb1a14e96009f, content=<a href='/topic/show?id=135e1e1794' target=_blank style='color:#2F92EE;'>#Abbvie#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1717, encryptionId=135e1e1794, topicName=Abbvie)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=34847549422, createdName=12498768m15(暂无昵称), createdTime=Sat Jun 06 09:39:52 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=601420, encodeId=af39601420f7, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>JAK抑制剂对重型新冠肺炎有效, beContent=null, objectType=article, channel=null, level=null, likeNumber=337, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, topicName=新冠肺炎)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Thu Jun 04 21:25:19 CST 2020, time=2020-06-04, status=1, ipAttribution=)]
  6. 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09:39:52 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1479600, encodeId=cb1a14e96009f, content=<a href='/topic/show?id=135e1e1794' target=_blank style='color:#2F92EE;'>#Abbvie#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1717, encryptionId=135e1e1794, topicName=Abbvie)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=34847549422, createdName=12498768m15(暂无昵称), createdTime=Sat Jun 06 09:39:52 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=601420, encodeId=af39601420f7, content=<a href='/topic/show?id=46ce580e865' target=_blank style='color:#2F92EE;'>#新冠肺炎#</a>JAK抑制剂对重型新冠肺炎有效, beContent=null, objectType=article, channel=null, level=null, likeNumber=337, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58078, encryptionId=46ce580e865, 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  7. 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  8. 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    2020-06-04 lovetcm

    #新冠肺炎#JAK抑制剂对重型新冠肺炎有效

    0

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