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EMA审查赛诺菲的I型糖尿病药物sotagliflozi

2018-03-30 MedSci MedSci原创

sotagliflozi

欧洲药品管理局已经接受对赛诺菲的实验性I型糖尿病药物sotagliflozi的审查。如果获得批准，口服治疗将用作胰岛素治疗的补充，以改善患有该病的成人的血糖控制。Sotagliflozin是与Lexicon Pharmaceuticals合作开发的，是SGLT-1和SGLT-2的一种研究性双重抑制剂，影响肠和肾对血糖（葡萄糖）的处置。该报告包含了来自inTandem临床试验计划的数据，其中三期临床


欧洲药品管理局已经接受对赛诺菲的实验性I型糖尿病药物sotagliflozi的审查。

如果获得批准，口服治疗将用作胰岛素治疗的补充，以改善患有该病的成人的血糖控制。

Sotagliflozin是与Lexicon Pharmaceuticals合作开发的，是SGLT-1和SGLT-2的一种研究性双重抑制剂，影响肠和肾对血糖（葡萄糖）的处置。

该报告包含了来自inTandem临床试验计划的数据，其中三期临床试验评估了该药物对大约3000名患有I型糖尿病的成年人的安全性和有效性。

在一项试验中，sagagliflozin组患者的比例明显增大，达到了主要终点--24周时糖化血红蛋白水平低于7％，随机分组后未发生严重低血糖或糖尿病酮症酸中毒的患者与安慰剂组患者分别为28.6%与15.2％。

赛诺菲公司的全球发展主管Jorge Insuasty说： "尽管最近取得了进展，但I型糖尿病管理的挑战阻碍了许多患者达到治疗目标。除了胰岛素外，还需要使用治疗方法来帮助I型糖尿病患者更好地控制他们的血糖。"

"Sotagliflozin是欧洲第一个接受监管审查的SGLT-1/2双重抑制剂...... 我们期待着通过审查过程与EMA合作，为患者带来这种潜在的治疗方法。"


此文系梅斯医学（MedSci)原创整理编译，转载需授权！

评论区 (4)
#插入话题
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    2018-04-01 fengyi812

    #EMA#

    0

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    2018-04-01 minhuang75_72521589

    #糖尿病药物#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1317390, encodeId=2e0b131e39045, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Sun Apr 01 13:42:00 CST 2018, time=2018-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1584114, encodeId=27af158411438, content=<a href='/topic/show?id=1f13e6767e9' target=_blank style='color:#2F92EE;'>#糖尿病药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76767, encryptionId=1f13e6767e9, topicName=糖尿病药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5edb17003695, createdName=minhuang75_72521589, createdTime=Sun Apr 01 13:42:00 CST 2018, time=2018-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=301699, encodeId=c55a301699a6, content=学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Sun Apr 01 09:05:03 CST 2018, time=2018-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=301315, encodeId=7026301315a3, content=学习了很有用, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Sat Mar 31 00:13:44 CST 2018, time=2018-03-31, status=1, ipAttribution=)]
    2018-04-01 1209e435m98(暂无昵称)

    学习了.谢谢分享

    0

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    2018-03-31 飛歌

    学习了很有用

    0