美国FDA批准新型TREMFYA(guselkumab)制剂治疗成人中度至重度斑块型银屑病

2019-02-28 不详 网络

强生公司今天宣布,美国食品和药品监督管理局(FDA)已批准新型TREMFYA®One-Press制剂,这是一种单剂量、患者控制的注射器,用于治疗中度至重度斑块状银屑病的成人患者。

强生公司今天宣布,美国食品和药品监督管理局(FDA)已批准新型TREMFYA®One-Press制剂,这是一种单剂量、患者控制的注射器,用于治疗中度至重度斑块状银屑病的成人患者。One-Press的设计考虑了患者的使用便捷性,它可以舒适被地握在手中,并提供可控的注射,并在整个过程中隐藏针头。在第0周和第4周开始给药后,TREMFYA以每8周一次的皮下注射100mg给药。TREMFYA®One-Press现已在美国上市。

有时,患有斑块状银屑病的患者可能由于许多因素(包括针头恐惧症)而难以进行自我给药治疗。在多中心和随机ORION研究中,患者对One-Press自我注射满意度的平均得分为9.18(其中10表示非常满意),易用性的平均得分为9.24(其中10表示非常容易)。


原始出处:

http://www.firstwordpharma.com/node/1627045#axzz5gj4KGYJT

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    2019-12-18 tongyongming
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createdName=liuyong2980, createdTime=Sat Apr 27 04:24:00 CST 2019, time=2019-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752252, encodeId=53331e52252ee, content=<a href='/topic/show?id=28a915303ec' target=_blank style='color:#2F92EE;'>#REM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15303, encryptionId=28a915303ec, topicName=REM)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=78bc36479935, createdName=tongyongming, createdTime=Wed Dec 18 01:24:00 CST 2019, time=2019-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796378, encodeId=d5e21e963783c, content=<a href='/topic/show?id=9a1b1e7916c' target=_blank style='color:#2F92EE;'>#TREM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17791, encryptionId=9a1b1e7916c, topicName=TREM)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Thu May 09 17:24:00 CST 2019, time=2019-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912095, encodeId=2d95191209590, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat May 04 20:24:00 CST 2019, time=2019-05-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256415, encodeId=befe12564158b, content=<a href='/topic/show?id=af4c1e797f8' target=_blank style='color:#2F92EE;'>#tremfya#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17797, encryptionId=af4c1e797f8, topicName=tremfya)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=754b42, createdName=Luyuxie_9, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330113, encodeId=d80013301135a, content=<a href='/topic/show?id=a91c5e92328' target=_blank style='color:#2F92EE;'>#斑块#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57923, encryptionId=a91c5e92328, topicName=斑块)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1349863, encodeId=b1de134986362, content=<a href='/topic/show?id=d8e783268f' target=_blank style='color:#2F92EE;'>#Guselkumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8326, encryptionId=d8e783268f, topicName=Guselkumab)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464189, encodeId=ca2e146418904, content=<a href='/topic/show?id=736f221484a' target=_blank style='color:#2F92EE;'>#中度至重度斑块型银屑病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22148, encryptionId=736f221484a, topicName=中度至重度斑块型银屑病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2d186606178, createdName=lg.zhao, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490375, encodeId=cc4214903e56b, content=<a href='/topic/show?id=f7e85e929c0' target=_blank style='color:#2F92EE;'>#斑块型银屑病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57929, encryptionId=f7e85e929c0, topicName=斑块型银屑病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=435a8732843, createdName=zz73, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=)]
  5. 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target=_blank style='color:#2F92EE;'>#tremfya#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17797, encryptionId=af4c1e797f8, topicName=tremfya)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=754b42, createdName=Luyuxie_9, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330113, encodeId=d80013301135a, content=<a href='/topic/show?id=a91c5e92328' target=_blank style='color:#2F92EE;'>#斑块#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57923, encryptionId=a91c5e92328, topicName=斑块)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1349863, encodeId=b1de134986362, content=<a href='/topic/show?id=d8e783268f' target=_blank style='color:#2F92EE;'>#Guselkumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8326, encryptionId=d8e783268f, topicName=Guselkumab)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464189, encodeId=ca2e146418904, content=<a href='/topic/show?id=736f221484a' target=_blank style='color:#2F92EE;'>#中度至重度斑块型银屑病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22148, encryptionId=736f221484a, topicName=中度至重度斑块型银屑病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2d186606178, createdName=lg.zhao, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490375, encodeId=cc4214903e56b, content=<a href='/topic/show?id=f7e85e929c0' target=_blank style='color:#2F92EE;'>#斑块型银屑病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57929, encryptionId=f7e85e929c0, topicName=斑块型银屑病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=435a8732843, createdName=zz73, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=)]
    2019-05-04 snf701207
  6. 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target=_blank style='color:#2F92EE;'>#tremfya#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17797, encryptionId=af4c1e797f8, topicName=tremfya)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=754b42, createdName=Luyuxie_9, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330113, encodeId=d80013301135a, content=<a href='/topic/show?id=a91c5e92328' target=_blank style='color:#2F92EE;'>#斑块#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57923, encryptionId=a91c5e92328, topicName=斑块)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, 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encryptionId=736f221484a, topicName=中度至重度斑块型银屑病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2d186606178, createdName=lg.zhao, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1490375, encodeId=cc4214903e56b, content=<a href='/topic/show?id=f7e85e929c0' target=_blank style='color:#2F92EE;'>#斑块型银屑病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57929, encryptionId=f7e85e929c0, topicName=斑块型银屑病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=435a8732843, createdName=zz73, createdTime=Sat Mar 02 09:24:00 CST 2019, time=2019-03-02, status=1, ipAttribution=)]
    2019-03-02 Luyuxie_9
  7. 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  8. 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  9. 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Janssen Biotech公司研发的guselkumab是一款新型银屑病药物。它作为一种单克隆抗体,不同于当前抗肿瘤坏死因子(TNF)的标准药物,拥有针对自身免疫炎性疾病的全新作用靶点,可结合并抑制体内的免疫炎性介质——白细胞介素-23(IL-23)。

DRUGS:Guselkumab获得首次全球认证

近日,美国强生研发的Guselkumab(Tremfya)已经获得美国FDA的上市审核用以治疗块型银屑病和银屑病型关节炎。和传统靶向TNF的抗炎抗体相比,Guselkumab特异性地作用于全新靶点白细胞介素(IL)-23。IL-23在辅助性T 细胞17(Th-17)的分化和增殖以及由其产生的包括IL-17和IL-22在内的促炎性细胞因子中起着关键作用。Th-17 / IL-17通路在抵御细菌和真菌

NEJM:Guselkumab和阿达木单抗治疗斑块型银屑病

对于治疗中度至重度斑块型银屑病,与已经建立的抗肿瘤坏死因子的疗法相比,目前对特异性抗白介素23治疗的效果知之甚少。