礼来的GLP-1受体激动剂Trulicity,获得FDA批准用于降低心血管风险

2020-02-25 不详 MedSci原创

礼来(Eli Lilly)的胰高血糖素样肽-1(GLP-1)受体激动剂Trulicity在美国获批了新的适应症,用于降低有或没有心血管疾病成年人的心血管事件。

礼来(Eli Lilly)的胰高血糖素样肽-1(GLP-1)受体激动剂Trulicity在美国获批了新的适应症,用于降低有或没有心血管疾病成年人的心血管事件。

Lilly的REWIND研究支持了美国食品和药物管理局(FDA)的批准,该研究对具有心血管(CV)危险因素的人群进行了研究,尽管其中大多数尚未发现心血管疾病。

该试验的数据表明,Trulicity的治疗可降低重大不良心血管事件(MACE)的风险。结果还表明,Trulicity在主要人口和疾病亚组中均显示出一致的MACE风险降低。

与安慰剂相比,Trulicity的治疗在患有2型糖尿病的中老年人中,将MACE降低了12%,包括心血管疾病死亡、非致命性心肌梗塞或非致命性中风,肾脏疾病的发生率降低了15%。

根据礼来公司的说法,在任何一级和二级预防人群中,Trulicity都是所有2型糖尿病药物中的首个获批用于降低心血管事件的药物。

Trulicity作为每周使用一次的GLP-1受体激动剂,于2014年在美国上市,用于改善2型糖尿病成年人的血糖控制。

原始出处:


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target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, 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=Thu Feb 04 08:20:00 CST 2021, time=2021-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1941535, encodeId=cb8519415355d, content=<a href='/topic/show?id=64c94e75a3' target=_blank style='color:#2F92EE;'>#City#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4775, encryptionId=64c94e75a3, topicName=City)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0cd7162, createdName=nakerunner, createdTime=Tue Nov 03 11:20:00 CST 2020, time=2020-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738572, encodeId=f70b1e38572ad, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eabf34462441, createdName=12498877m109暂无昵称, createdTime=Fri Jul 31 00:20:00 CST 2020, time=2020-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1294034, encodeId=53e512940346e, content=<a href='/topic/show?id=bb0e8081b2' target=_blank style='color:#2F92EE;'>#GLP-1受体激动剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8081, encryptionId=bb0e8081b2, topicName=GLP-1受体激动剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e183245, createdName=Eleven11, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422744, encodeId=bd8d1422e447c, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8077, encryptionId=54fa80e701, topicName=GLP-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f8f23732777, createdName=yibei, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627808, encodeId=a624162e80814, content=<a href='/topic/show?id=ab4f66e8913' target=_blank style='color:#2F92EE;'>#激动剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66789, encryptionId=ab4f66e8913, topicName=激动剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=95bc21134754, createdName=medscijoin, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=379669, encodeId=00483e9669b0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f73a5226174, createdName=1478e879m90暂无昵称, createdTime=Tue Feb 25 19:35:32 CST 2020, time=2020-02-25, status=1, ipAttribution=)]
    2021-02-04 bugit
  5. [GetPortalCommentsPageByObjectIdResponse(id=1796491, encodeId=2ad01e9649151, content=<a href='/topic/show?id=95181e871da' target=_blank style='color:#2F92EE;'>#Trulicity#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17871, encryptionId=95181e871da, topicName=Trulicity)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/6F20312C71B4B22F603078C6DCFA72CE/100, createdBy=d3572500071, createdName=ms306040998833292, createdTime=Fri Aug 14 22:20:00 CST 2020, time=2020-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818661, encodeId=4bcd1818661b7, content=<a href='/topic/show?id=841398124b3' target=_blank style='color:#2F92EE;'>#降低心血管风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98124, 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target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, 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=Thu Feb 04 08:20:00 CST 2021, time=2021-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1941535, encodeId=cb8519415355d, content=<a href='/topic/show?id=64c94e75a3' target=_blank style='color:#2F92EE;'>#City#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4775, encryptionId=64c94e75a3, topicName=City)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0cd7162, createdName=nakerunner, createdTime=Tue Nov 03 11:20:00 CST 2020, time=2020-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738572, encodeId=f70b1e38572ad, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eabf34462441, createdName=12498877m109暂无昵称, createdTime=Fri Jul 31 00:20:00 CST 2020, time=2020-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1294034, encodeId=53e512940346e, content=<a href='/topic/show?id=bb0e8081b2' target=_blank style='color:#2F92EE;'>#GLP-1受体激动剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8081, encryptionId=bb0e8081b2, topicName=GLP-1受体激动剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e183245, createdName=Eleven11, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422744, encodeId=bd8d1422e447c, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8077, encryptionId=54fa80e701, topicName=GLP-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f8f23732777, createdName=yibei, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627808, encodeId=a624162e80814, content=<a href='/topic/show?id=ab4f66e8913' target=_blank style='color:#2F92EE;'>#激动剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66789, encryptionId=ab4f66e8913, topicName=激动剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=95bc21134754, createdName=medscijoin, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=379669, encodeId=00483e9669b0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f73a5226174, createdName=1478e879m90暂无昵称, createdTime=Tue Feb 25 19:35:32 CST 2020, time=2020-02-25, status=1, ipAttribution=)]
    2020-11-03 nakerunner
  6. 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  7. 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topicList=[TopicDto(id=66789, encryptionId=ab4f66e8913, topicName=激动剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=95bc21134754, createdName=medscijoin, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=379669, encodeId=00483e9669b0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f73a5226174, createdName=1478e879m90暂无昵称, createdTime=Tue Feb 25 19:35:32 CST 2020, time=2020-02-25, status=1, ipAttribution=)]
  8. [GetPortalCommentsPageByObjectIdResponse(id=1796491, encodeId=2ad01e9649151, content=<a href='/topic/show?id=95181e871da' target=_blank style='color:#2F92EE;'>#Trulicity#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17871, encryptionId=95181e871da, topicName=Trulicity)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/6F20312C71B4B22F603078C6DCFA72CE/100, createdBy=d3572500071, createdName=ms306040998833292, createdTime=Fri Aug 14 22:20:00 CST 2020, time=2020-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818661, encodeId=4bcd1818661b7, content=<a href='/topic/show?id=841398124b3' target=_blank style='color:#2F92EE;'>#降低心血管风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98124, 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target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, 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=Thu Feb 04 08:20:00 CST 2021, time=2021-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1941535, encodeId=cb8519415355d, content=<a href='/topic/show?id=64c94e75a3' target=_blank style='color:#2F92EE;'>#City#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4775, encryptionId=64c94e75a3, topicName=City)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0cd7162, createdName=nakerunner, createdTime=Tue Nov 03 11:20:00 CST 2020, time=2020-11-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738572, encodeId=f70b1e38572ad, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=eabf34462441, createdName=12498877m109暂无昵称, createdTime=Fri Jul 31 00:20:00 CST 2020, time=2020-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1294034, encodeId=53e512940346e, content=<a href='/topic/show?id=bb0e8081b2' target=_blank style='color:#2F92EE;'>#GLP-1受体激动剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8081, encryptionId=bb0e8081b2, topicName=GLP-1受体激动剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e183245, createdName=Eleven11, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422744, encodeId=bd8d1422e447c, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8077, encryptionId=54fa80e701, topicName=GLP-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f8f23732777, createdName=yibei, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627808, encodeId=a624162e80814, content=<a href='/topic/show?id=ab4f66e8913' target=_blank style='color:#2F92EE;'>#激动剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66789, encryptionId=ab4f66e8913, topicName=激动剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=95bc21134754, createdName=medscijoin, createdTime=Thu Feb 27 10:20:00 CST 2020, time=2020-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=379669, encodeId=00483e9669b0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f73a5226174, createdName=1478e879m90暂无昵称, createdTime=Tue Feb 25 19:35:32 CST 2020, time=2020-02-25, status=1, ipAttribution=)]
    2020-02-27 yibei
  9. [GetPortalCommentsPageByObjectIdResponse(id=1796491, encodeId=2ad01e9649151, content=<a href='/topic/show?id=95181e871da' target=_blank style='color:#2F92EE;'>#Trulicity#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17871, encryptionId=95181e871da, topicName=Trulicity)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/6F20312C71B4B22F603078C6DCFA72CE/100, createdBy=d3572500071, createdName=ms306040998833292, createdTime=Fri Aug 14 22:20:00 CST 2020, time=2020-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818661, encodeId=4bcd1818661b7, content=<a href='/topic/show?id=841398124b3' target=_blank style='color:#2F92EE;'>#降低心血管风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98124, 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  10. 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    2020-02-25 1478e879m90暂无昵称

    学习

    0

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Now this is not the end. It is noteven the beginning of the end. But it is, perhaps, the end of the beginning.上海市胸科医院肿瘤科主任陆舜教授借用丘吉尔的名言评价了信达生物和礼来制药的合作。

礼来终止与NextCure公司一年前签订的14亿美元合作协议,后者候选药物为靶向M2巨噬细胞表面的Siglec-15单抗

一年前,礼来与免疫肿瘤生物技术公司NextCure签署价值高达14亿美元的协议,但是现在礼来决定终止合作关系。根据该协议的条款(于2018年11月达成协议),礼来向NextCure提供了3270万美元,其中包括2500万美元的前期付款,随后的季度研发支持付款以及对该公司的1500万美元股权投资。

又一个中晚期阿尔茨海默症药物失败,这次是礼来公司

礼来制药公司宣布,其靶向β淀粉样蛋白的阿尔茨海默氏症单抗solanezumab未能达到DIAN-TU II / III期研究的主要终点。该公司表示,次要终点和生物标志物的其他分析仍在进行中,并将在2020年4月的Advances in Alzheimer's and Parkinson's Therapies Focus Meeting会议上进行介绍。

礼来宣布以11亿美元收购Dermira,同时获得中度至重度特应性皮炎III期IL-13单抗lebrikizumab

礼来制药公司已宣布计划以每股18.75美元的现金,总价约11亿美元的价格收购Dermira,以扩大其免疫学管线。作为协议的一部分,礼来公司将获得目前处于三期临床的中度至重度特应性皮炎候选药物lebrikizumab。

礼来和Incyte宣布其口服JAK抑制剂Baricitinib在中度至重度特应性皮炎患者中进行的3期临床研究BREEZE-AD5的阳性结果

礼来和Incyte宣布,其口服选择性JAK抑制剂baricitinib达到了BREEZE-AD5的主要研究终点。该研究为3期临床、随机安慰剂对照,用于评估Baricitinib治疗成人中重度特应性皮炎(AD)患者安全性和有效性的研究。主要终点指标定义为第16周时,湿疹面积和严重程度指数(EASI)与基线相比至少达到75%或更高比例。