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礼来SGLT-2抑制剂闪亮登场——勃林格-礼来联盟美国推出降糖新药Jardiance

2014-08-28 佚名 生物谷

勃林格-礼来糖尿病联盟8月26日宣布,在美国推出糖尿病新药Jardiance(empagliflozin),该药于今年8月1日获FDA批准,是该联盟在美国获批的第3个糖尿病产品。Jardiance的上市,对礼来而言尤其重要,该公司目前正面临着重磅产品的专利到期,正指望在短期内推出新产品以恢复增长。 此前,FDA因勃林格生产工厂问题拒绝批准Jardiance,导致Jardiance上市推迟了5个月

勃林格-礼来糖尿病联盟8月26日宣布,在美国推出糖尿病新药Jardiance(empagliflozin),该药于今年8月1日获FDA批准,是该联盟在美国获批的第3个糖尿病产品。Jardiance的上市,对礼来而言尤其重要,该公司目前正面临着重磅产品的专利到期,正指望在短期内推出新产品以恢复增长。

此前,FDA因勃林格生产工厂问题拒绝批准Jardiance,导致Jardiance上市推迟了5个月之久,给礼来带来了不小的麻烦。

同时,Jardiance仍代表着礼来同其他制药公司SGLT-2抑制剂类药物抗衡的最佳人选,如强生的Invokana、阿斯利康和百时美施贵宝的Farxiga(dapagliflozin)。Invokana于2013年11月获FDA批准,Farxiga则在经历长期审查推迟后也最终于2014年1月获FDA批准。

Jardiance属于钠-葡萄糖协同转运蛋白-2(SGLT-2)抑制剂类药物。新兴的SGLT-2抑制剂类药物,已被证实能够阻断肾脏中葡萄糖的再吸收作用,将过多的葡萄糖排泄到体外,从而达到降低血糖水平的效果,而且该降糖效果不依赖于β细胞功能和胰岛素抵抗。

Jardiance获批剂量包括10mg和25mg片剂,每日一次,可单独用药也可与其他降糖药联合用药,包括胰岛素和二甲双胍。Jardiance的获批,是基于一项涵括超过10个跨国III期试验的大型临床项目的数据,涉及超过1.3万例2型糖尿病患者。该项目数据表明,Jardiance 10mg和25mg剂量作为单药疗法或与广泛的背景疗法(包括二甲双胍,磺酰脲,胰岛素,pioglitazone等)联合用药,均显著降低了患者的糖化血红蛋白(HA1c)水平,同时也显著降低了体重、血压。

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    2014-11-16 tulenzi
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content=<a href='/topic/show?id=bbd780e4884' target=_blank style='color:#2F92EE;'>#联盟#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80748, encryptionId=bbd780e4884, topicName=联盟)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d7fc9269968, createdName=zexyw04, createdTime=Sat Aug 30 00:19:00 CST 2014, time=2014-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585509, encodeId=c80e15855093e, content=<a href='/topic/show?id=0d151025305' target=_blank style='color:#2F92EE;'>#Jardiance#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10253, encryptionId=0d151025305, topicName=Jardiance)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=065617213305, createdName=lq1773, createdTime=Sat Aug 30 00:19:00 CST 2014, time=2014-08-30, status=1, ipAttribution=)]
  5. 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content=<a href='/topic/show?id=bbd780e4884' target=_blank style='color:#2F92EE;'>#联盟#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80748, encryptionId=bbd780e4884, topicName=联盟)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d7fc9269968, createdName=zexyw04, createdTime=Sat Aug 30 00:19:00 CST 2014, time=2014-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585509, encodeId=c80e15855093e, content=<a href='/topic/show?id=0d151025305' target=_blank style='color:#2F92EE;'>#Jardiance#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10253, encryptionId=0d151025305, topicName=Jardiance)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=065617213305, createdName=lq1773, createdTime=Sat Aug 30 00:19:00 CST 2014, time=2014-08-30, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=2081962, encodeId=9a2520819620f, content=<a href='/topic/show?id=acf116218e6' target=_blank style='color:#2F92EE;'>#SGLT-2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16218, encryptionId=acf116218e6, topicName=SGLT-2)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0a3a2500014, createdName=fmq_28614553, createdTime=Thu Jan 15 00:19:00 CST 2015, time=2015-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1995468, encodeId=4c3c19954682e, content=<a href='/topic/show?id=992411149e' target=_blank style='color:#2F92EE;'>#2抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, 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encryptionId=afda591646, topicName=DIA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=987022654425, createdName=ms9608593228839890, createdTime=Mon Jul 27 06:19:00 CST 2015, time=2015-07-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793900, encodeId=24811e93900c2, content=<a href='/topic/show?id=722516221ec' target=_blank style='color:#2F92EE;'>#SGLT-2抑制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16221, encryptionId=722516221ec, topicName=SGLT-2抑制)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=052a130, createdName=yyj062, createdTime=Mon Dec 22 10:19:00 CST 2014, time=2014-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2054999, encodeId=d4ed2054999cd, content=<a href='/topic/show?id=8683e68224c' target=_blank style='color:#2F92EE;'>#糖新药#</a>, beContent=null, 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content=<a href='/topic/show?id=bbd780e4884' target=_blank style='color:#2F92EE;'>#联盟#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80748, encryptionId=bbd780e4884, topicName=联盟)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d7fc9269968, createdName=zexyw04, createdTime=Sat Aug 30 00:19:00 CST 2014, time=2014-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585509, encodeId=c80e15855093e, content=<a href='/topic/show?id=0d151025305' target=_blank style='color:#2F92EE;'>#Jardiance#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10253, encryptionId=0d151025305, topicName=Jardiance)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=065617213305, createdName=lq1773, createdTime=Sat Aug 30 00:19:00 CST 2014, time=2014-08-30, status=1, ipAttribution=)]
  7. 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objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76822, encryptionId=8683e68224c, topicName=糖新药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Tue Apr 07 04:19:00 CST 2015, time=2015-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851194, encodeId=937d185119482, 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=46, 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=Tue Mar 17 03:19:00 CST 2015, time=2015-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1496531, encodeId=efdd149653104, content=<a href='/topic/show?id=bbd780e4884' target=_blank style='color:#2F92EE;'>#联盟#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80748, encryptionId=bbd780e4884, topicName=联盟)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d7fc9269968, createdName=zexyw04, createdTime=Sat Aug 30 00:19:00 CST 2014, time=2014-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1585509, encodeId=c80e15855093e, content=<a href='/topic/show?id=0d151025305' target=_blank style='color:#2F92EE;'>#Jardiance#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10253, encryptionId=0d151025305, topicName=Jardiance)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=065617213305, createdName=lq1773, createdTime=Sat Aug 30 00:19:00 CST 2014, time=2014-08-30, status=1, ipAttribution=)]
    2015-03-17 jklm09
  8. 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    2014-08-30 zexyw04
  9. 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    2014-08-30 lq1773

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