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礼来的IL-17A单抗Taltz获得FDA批准扩展用于活动性强直性脊柱炎

2019-08-27 不详 MedSci原创

礼来宣布,FDA已扩大其IL-17A单抗Taltz(ixekizumab)的应用范围,扩展用于治疗患有活动性强直性脊柱炎的成人,也称为射线照相轴性脊柱关节炎。该公司美国免疫学部副总裁丽贝卡o莫里森说:"强直性脊柱炎是一种具有挑战性的疾病,可引起严重的背部疼痛,如果不及时治疗,会严重影响患者的活动能力,"并补充道,"我们很高兴现在提供Taltz用于缓解该类患者的症状。"

礼来宣布,FDA已扩大其IL-17A单抗Taltz(ixekizumab)的应用范围,扩展用于治疗患有活动性强直性脊柱炎的成人,也称为射线照相轴性脊柱关节炎。该公司美国免疫学部副总裁丽贝卡o莫里森说:"强直性脊柱炎是一种具有挑战性的疾病,可引起严重的背部疼痛,如果不及时治疗,会严重影响患者的活动能力,"并补充道,"我们很高兴现在提供Taltz用于缓解该类患者的症状。"

两项III期研究的数据支持此次批准,共涉及657名患有活动性强直性脊柱炎的成年人。COAST-W研究涉及之前对TNF抑制剂反应不充分或不耐受的患者。

Taltz最初于2016年在美国批准用于治疗患有中度至重度斑块状银屑病的成人,后来扩展至包括具有活动性银屑病关节炎的成人。去年,IL-17A靶向抗体也获得FDA批准,用于涉及生殖器区域的牛皮癣。

Taltz第二季度的销售额同比增长 61%至3.538亿美元,其中包括由于需求增加而在美国的收入增长54%。

原始出处:


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    2020-04-14 hjwang88
  3. 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    2020-07-24 bugit
  4. 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createdBy=3a9a26964526, createdName=hjwang88, createdTime=Tue Apr 14 02:16:00 CST 2020, time=2020-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839713, encodeId=7f131839e13aa, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Jul 24 04:16:00 CST 2020, time=2020-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1861334, encodeId=379d1861334c8, content=<a href='/topic/show?id=401a23e102' target=_blank style='color:#2F92EE;'>#ALT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2371, encryptionId=401a23e102, topicName=ALT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Wed Feb 26 03:16:00 CST 2020, time=2020-02-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1946888, encodeId=632719468889c, content=<a href='/topic/show?id=9a3950183e9' target=_blank style='color:#2F92EE;'>#强直性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50183, encryptionId=9a3950183e9, topicName=强直性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKeia4TJeMGvEH3wKKIBNjuHuIic1HDNOB10j4tCd3nbylxkxm6HSMfEaKkSu6OZOak4uZv7UVicsWEg/132, createdBy=bc9a2500116, createdName=zywlvao, createdTime=Fri Jan 31 04:16:00 CST 2020, time=2020-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662167, encodeId=b9f3166216ebd, content=<a 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time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440393, encodeId=c8a714403939d, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Thu Aug 29 01:16:00 CST 2019, time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1482914, encodeId=3ac414829141b, content=<a href='/topic/show?id=2443963952' target=_blank style='color:#2F92EE;'>#IL-17A#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9639, encryptionId=2443963952, topicName=IL-17A)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0ae57859469, createdName=12498bf3m27暂无昵称, createdTime=Thu Aug 29 01:16:00 CST 2019, time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1508246, encodeId=675515082467e, content=<a href='/topic/show?id=8d4596248e' target=_blank style='color:#2F92EE;'>#IL-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, 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=Thu Aug 29 01:16:00 CST 2019, time=2019-08-29, status=1, ipAttribution=)]
    2020-02-26 shizhenshan
  5. [GetPortalCommentsPageByObjectIdResponse(id=1723974, encodeId=ee391e23974a0, content=<a href='/topic/show?id=2d996516e7c' target=_blank style='color:#2F92EE;'>#活动性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65167, encryptionId=2d996516e7c, topicName=活动性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=596833562866, createdName=楚秀娟, createdTime=Mon Jan 06 10:16:00 CST 2020, time=2020-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1674293, encodeId=05be16e4293c3, content=<a href='/topic/show?id=a5261e119fc' target=_blank style='color:#2F92EE;'>#Taltz#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17119, encryptionId=a5261e119fc, topicName=Taltz)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3a9a26964526, createdName=hjwang88, createdTime=Tue Apr 14 02:16:00 CST 2020, time=2020-04-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839713, encodeId=7f131839e13aa, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Jul 24 04:16:00 CST 2020, time=2020-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1861334, encodeId=379d1861334c8, content=<a href='/topic/show?id=401a23e102' target=_blank style='color:#2F92EE;'>#ALT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2371, 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time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440393, encodeId=c8a714403939d, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Thu Aug 29 01:16:00 CST 2019, time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1482914, encodeId=3ac414829141b, content=<a href='/topic/show?id=2443963952' target=_blank style='color:#2F92EE;'>#IL-17A#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9639, encryptionId=2443963952, topicName=IL-17A)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0ae57859469, createdName=12498bf3m27暂无昵称, createdTime=Thu Aug 29 01:16:00 CST 2019, time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1508246, encodeId=675515082467e, content=<a href='/topic/show?id=8d4596248e' target=_blank style='color:#2F92EE;'>#IL-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, 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=Thu Aug 29 01:16:00 CST 2019, time=2019-08-29, status=1, ipAttribution=)]
    2020-01-31 zywlvao
  6. [GetPortalCommentsPageByObjectIdResponse(id=1723974, encodeId=ee391e23974a0, content=<a href='/topic/show?id=2d996516e7c' target=_blank style='color:#2F92EE;'>#活动性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65167, encryptionId=2d996516e7c, topicName=活动性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=596833562866, createdName=楚秀娟, createdTime=Mon Jan 06 10:16:00 CST 2020, time=2020-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1674293, encodeId=05be16e4293c3, content=<a href='/topic/show?id=a5261e119fc' target=_blank style='color:#2F92EE;'>#Taltz#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17119, encryptionId=a5261e119fc, topicName=Taltz)], attachment=null, authenticateStatus=null, createdAvatar=null, 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time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440393, encodeId=c8a714403939d, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Thu Aug 29 01:16:00 CST 2019, time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1482914, encodeId=3ac414829141b, content=<a href='/topic/show?id=2443963952' target=_blank style='color:#2F92EE;'>#IL-17A#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9639, encryptionId=2443963952, topicName=IL-17A)], attachment=null, 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  7. [GetPortalCommentsPageByObjectIdResponse(id=1723974, encodeId=ee391e23974a0, content=<a href='/topic/show?id=2d996516e7c' target=_blank style='color:#2F92EE;'>#活动性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65167, encryptionId=2d996516e7c, topicName=活动性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=596833562866, createdName=楚秀娟, createdTime=Mon Jan 06 10:16:00 CST 2020, time=2020-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1674293, encodeId=05be16e4293c3, content=<a href='/topic/show?id=a5261e119fc' target=_blank style='color:#2F92EE;'>#Taltz#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17119, encryptionId=a5261e119fc, topicName=Taltz)], attachment=null, authenticateStatus=null, createdAvatar=null, 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time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440393, encodeId=c8a714403939d, content=<a href='/topic/show?id=6f0e845427f' target=_blank style='color:#2F92EE;'>#脊柱炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84542, encryptionId=6f0e845427f, topicName=脊柱炎)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50834728424, createdName=1249898am16暂无昵称, createdTime=Thu Aug 29 01:16:00 CST 2019, time=2019-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1482914, encodeId=3ac414829141b, content=<a href='/topic/show?id=2443963952' target=_blank style='color:#2F92EE;'>#IL-17A#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9639, encryptionId=2443963952, topicName=IL-17A)], attachment=null, 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    2019-08-29 fzwish20000
  8. 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  9. 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    2019-08-29 jjjiang0202

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10亿美元!礼来买下非阿片类镇痛新药全球**权

5月28日,礼来宣布了一项资产引进协议,获得了Centrexion Therapeutics公司用于疼痛治疗的CNTX-0290的全球独家权利。

礼来IL-23抑制剂治疗克罗恩病2期结果积极,今年启动3期试验

礼来公司在美国消化疾病周(DDW)医学会议上,公布了该公司开发的IL-23抑制剂mirikizumab在治疗中重度克罗恩病患者的2期临床试验中获得的积极结果。

信达生物和礼来合作的双特异性抗体临床试验获NMPA批准

信达生物制药上周宣布其双特异性抗体(研发代号:IBI318),已于近期获得国家药品监督管理局(NMPA)颁发的药物临床试验批件,拟开展针对血液肿瘤和晚期实体瘤的临床研究。

礼来胰岛素价格5年上涨52% 净收益却下降8% 利润去了哪里?

日前,礼来公司因胰岛素价格大幅上涨诉讼缠身,美国国会正在对其进行审查,公众也因药价上涨对其进行了抨击。2018年10月,美国明尼苏达州司法部长Lori Swanson对三家最大的胰岛素制造商提起价格欺诈诉讼。在诉讼中,Swanson称礼来、赛诺菲和诺和诺德欺骗性地提高了胰岛素的定价,而且飙升的价格使得患者无法负担得起这些救命药物。

礼来携手华医网启动大规模医生线上教育项目,涵盖肿瘤等四大疾病领域

5月10日,由全球领先的制药公司礼来与国内知名的互联网医学教育机构华医网联手打造的“医路同行,育见未来”医生线上教育项目于今日正式启动。项目将整合双方各自的优势资源,搭建一个面向临床医生的片段化学习平台,通过提供灵活、便捷、丰富的线上再教育课程,进一步提高我国在职医生的医疗教育水平,推动我国医疗卫生事业的整体发展步伐。

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