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美国FDA拒绝了双重SGLT1和SGLT2抑制剂Zynquista治疗1型糖尿病的申请

2019-03-24 不详 网络

ZynquistaSGLT2SGLT11型糖尿病
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赛诺菲和Lexicon制药公司周五（2019年3月23日）宣布，FDA已拒绝其双重SGLT1和SGLT2抑制剂Zynquista（sotagliflozin）合并胰岛素用于治疗成人1型糖尿病的申请。

赛诺菲和Lexicon制药公司周五（2019年3月23日）宣布，FDA已拒绝其双重SGLT1和SGLT2抑制剂Zynquista（sotagliflozin）合并胰岛素用于治疗成人1型糖尿病的申请。

2019年1月份，FDA顾问小组对是否支持Zynquista的批准存在分歧，而机构工作人员对使用该药物治疗的患者中糖尿病酮酸中毒风险较高且可能具有无法预测的风险表示担忧。但2017年的III期试验表明，Zynquista的治疗没有导致严重低血糖或糖尿病酮酸中毒的发作，Zynquista还在Tandem1和Tandem2试验中达到III期试验的主要终点。


原始出处：

http://www.firstwordpharma.com/node/1630997?tsid=4#axzz5j31eEshK

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    2019-09-21 liuquan

    #2抑制剂#

    0

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    2019-03-30 tulenzi

    #SGLT#

    0

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    2019-12-12 licz0423

    #SGLT1#

    0

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    2019-08-21 12498710m22暂无昵称

    #Zynquista#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1995555, encodeId=dcd2199555583, 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=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28b7142, createdName=liuquan, createdTime=Sat Sep 21 20:48:00 CST 2019, time=2019-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793821, encodeId=ebe61e9382147, content=<a href='/topic/show?id=5a3f1621e7d' target=_blank style='color:#2F92EE;'>#SGLT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16217, encryptionId=5a3f1621e7d, topicName=SGLT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=54f9127, createdName=tulenzi, createdTime=Sat Mar 30 18:48:00 CST 2019, time=2019-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793895, encodeId=4b351e93895dc, content=<a href='/topic/show?id=c45f1622379' target=_blank style='color:#2F92EE;'>#SGLT1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16223, encryptionId=c45f1622379, topicName=SGLT1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5fca128, createdName=licz0423, createdTime=Thu Dec 12 01:48:00 CST 2019, time=2019-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738196, encodeId=e3b31e381960d, content=<a href='/topic/show?id=7bcf1911119' target=_blank style='color:#2F92EE;'>#Zynquista#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19111, encryptionId=7bcf1911119, topicName=Zynquista)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7234375104, createdName=12498710m22暂无昵称, createdTime=Wed Aug 21 19:48:00 CST 2019, time=2019-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851946, encodeId=ec4a18519464b, 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=27, 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=Sun Jul 07 02:48:00 CST 2019, time=2019-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503780, encodeId=9b6b1503e804f, content=<a href='/topic/show?id=60b916226e1' target=_blank style='color:#2F92EE;'>#SGLT2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16226, encryptionId=60b916226e1, topicName=SGLT2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3afa9693555, createdName=jiekemin, createdTime=Tue Mar 26 00:48:00 CST 2019, time=2019-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551434, encodeId=b0e8155143454, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Mar 26 00:48:00 CST 2019, time=2019-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1042310, encodeId=c1151042310cf, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Mar 24 12:48:00 CST 2019, time=2019-03-24, status=1, ipAttribution=)]
    2019-07-07 jklm09

    #抑制剂#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1995555, encodeId=dcd2199555583, 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=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28b7142, createdName=liuquan, createdTime=Sat Sep 21 20:48:00 CST 2019, time=2019-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793821, encodeId=ebe61e9382147, content=<a href='/topic/show?id=5a3f1621e7d' target=_blank style='color:#2F92EE;'>#SGLT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16217, encryptionId=5a3f1621e7d, topicName=SGLT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=54f9127, createdName=tulenzi, createdTime=Sat Mar 30 18:48:00 CST 2019, time=2019-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793895, encodeId=4b351e93895dc, content=<a href='/topic/show?id=c45f1622379' target=_blank style='color:#2F92EE;'>#SGLT1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16223, encryptionId=c45f1622379, topicName=SGLT1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5fca128, createdName=licz0423, createdTime=Thu Dec 12 01:48:00 CST 2019, time=2019-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738196, encodeId=e3b31e381960d, content=<a href='/topic/show?id=7bcf1911119' target=_blank style='color:#2F92EE;'>#Zynquista#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19111, encryptionId=7bcf1911119, topicName=Zynquista)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7234375104, createdName=12498710m22暂无昵称, createdTime=Wed Aug 21 19:48:00 CST 2019, time=2019-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851946, encodeId=ec4a18519464b, 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=27, 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=Sun Jul 07 02:48:00 CST 2019, time=2019-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503780, encodeId=9b6b1503e804f, content=<a href='/topic/show?id=60b916226e1' target=_blank style='color:#2F92EE;'>#SGLT2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16226, encryptionId=60b916226e1, topicName=SGLT2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3afa9693555, createdName=jiekemin, createdTime=Tue Mar 26 00:48:00 CST 2019, time=2019-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551434, encodeId=b0e8155143454, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Mar 26 00:48:00 CST 2019, time=2019-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1042310, encodeId=c1151042310cf, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Mar 24 12:48:00 CST 2019, time=2019-03-24, status=1, ipAttribution=)]
    2019-03-26 jiekemin

    #SGLT2#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1995555, encodeId=dcd2199555583, 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=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28b7142, createdName=liuquan, createdTime=Sat Sep 21 20:48:00 CST 2019, time=2019-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793821, encodeId=ebe61e9382147, content=<a href='/topic/show?id=5a3f1621e7d' target=_blank style='color:#2F92EE;'>#SGLT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16217, encryptionId=5a3f1621e7d, topicName=SGLT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=54f9127, createdName=tulenzi, createdTime=Sat Mar 30 18:48:00 CST 2019, time=2019-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793895, encodeId=4b351e93895dc, content=<a href='/topic/show?id=c45f1622379' target=_blank style='color:#2F92EE;'>#SGLT1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16223, encryptionId=c45f1622379, topicName=SGLT1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5fca128, createdName=licz0423, createdTime=Thu Dec 12 01:48:00 CST 2019, time=2019-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738196, encodeId=e3b31e381960d, content=<a href='/topic/show?id=7bcf1911119' target=_blank style='color:#2F92EE;'>#Zynquista#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19111, encryptionId=7bcf1911119, topicName=Zynquista)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7234375104, createdName=12498710m22暂无昵称, createdTime=Wed Aug 21 19:48:00 CST 2019, time=2019-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851946, encodeId=ec4a18519464b, 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=27, 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=Sun Jul 07 02:48:00 CST 2019, time=2019-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503780, encodeId=9b6b1503e804f, content=<a href='/topic/show?id=60b916226e1' target=_blank style='color:#2F92EE;'>#SGLT2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16226, encryptionId=60b916226e1, topicName=SGLT2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3afa9693555, createdName=jiekemin, createdTime=Tue Mar 26 00:48:00 CST 2019, time=2019-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551434, encodeId=b0e8155143454, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Mar 26 00:48:00 CST 2019, time=2019-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1042310, encodeId=c1151042310cf, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Mar 24 12:48:00 CST 2019, time=2019-03-24, status=1, ipAttribution=)]
    2019-03-26 zhouqu_8

    #美国FDA#

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1995555, encodeId=dcd2199555583, 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=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1114, encryptionId=992411149e, topicName=2抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=28b7142, createdName=liuquan, createdTime=Sat Sep 21 20:48:00 CST 2019, time=2019-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793821, encodeId=ebe61e9382147, content=<a href='/topic/show?id=5a3f1621e7d' target=_blank style='color:#2F92EE;'>#SGLT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16217, encryptionId=5a3f1621e7d, topicName=SGLT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=54f9127, createdName=tulenzi, createdTime=Sat Mar 30 18:48:00 CST 2019, time=2019-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793895, encodeId=4b351e93895dc, content=<a href='/topic/show?id=c45f1622379' target=_blank style='color:#2F92EE;'>#SGLT1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16223, encryptionId=c45f1622379, topicName=SGLT1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5fca128, createdName=licz0423, createdTime=Thu Dec 12 01:48:00 CST 2019, time=2019-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738196, encodeId=e3b31e381960d, content=<a href='/topic/show?id=7bcf1911119' target=_blank style='color:#2F92EE;'>#Zynquista#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19111, encryptionId=7bcf1911119, topicName=Zynquista)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7234375104, createdName=12498710m22暂无昵称, createdTime=Wed Aug 21 19:48:00 CST 2019, time=2019-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851946, encodeId=ec4a18519464b, 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=27, 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=Sun Jul 07 02:48:00 CST 2019, time=2019-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503780, encodeId=9b6b1503e804f, content=<a href='/topic/show?id=60b916226e1' target=_blank style='color:#2F92EE;'>#SGLT2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16226, encryptionId=60b916226e1, topicName=SGLT2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3afa9693555, createdName=jiekemin, createdTime=Tue Mar 26 00:48:00 CST 2019, time=2019-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551434, encodeId=b0e8155143454, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Mar 26 00:48:00 CST 2019, time=2019-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1042310, encodeId=c1151042310cf, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Mar 24 12:48:00 CST 2019, time=2019-03-24, status=1, ipAttribution=)]
    2019-03-24 misszhang

    谢谢MedSci提供最新的资讯

    0