阿斯利康降糖药saxa/dapa（沙格列汀/达格列净）获欧盟CHMP支持批准，将成欧洲DPP-4i/SGLT-2i降糖药

2016-05-28 佚名生物谷Bioon.com

英国制药巨头阿斯利康（AstraZeneca）糖尿病管线近日在欧盟监管方面传来喜讯，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）支持批准糖尿病复方药saxa/dapa（saxagliptin/dapagliflozin，沙格列汀/达格列净），用于2型糖尿病成人患者的治疗。 saxa/dapa是由固定剂量的二肽基肽酶-4抑制剂（DPP-4i）saxagliptin（沙格列汀）和钠-葡萄糖

英国制药巨头阿斯利康（AstraZeneca）糖尿病管线近日在欧盟监管方面传来喜讯，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）支持批准糖尿病复方药saxa/dapa（saxagliptin/dapagliflozin，沙格列汀/达格列净），用于2型糖尿病成人患者的治疗。

saxa/dapa是由固定剂量的二肽基肽酶-4抑制剂（DPP-4i）saxagliptin（沙格列汀）和钠-葡萄糖协同转运蛋白-2抑制剂（SGLT-2i）dapagliflozin（达格列净）组成的复方药物，目前正开发用于18岁及以上2型糖尿病成人患者的治疗，该药适用人群为：二甲双胍和/或磺脲类治疗血糖控制不佳的患者，saxa/dapa中任一个单组分saxagliptin或dapagliflozin治疗血糖控制不佳的患者，或已经正在接受saxagliptin和dapagliflozin任意组合治疗的患者。

saxa/dapa上市许可申请（MAA）的提交，是基于在2型糖尿病群体中开展的3个临床研究。其中2个研究的数据显示，与saxagliptin+二甲双胍组合或dapagliflozin+二甲双胍组合治疗血糖控制不佳且需要额外降糖疗法的对照组相比，saxagliptin+dapagliflozin+二甲双胍三联治疗组糖化血红蛋白（HbA1c）水平实现统计学意义的显著降低。另一个研究表明，与saxagliptin或dapagliflozin添加至二甲双胍治疗的对照组相比，将saxagliptin+dapagliflozin添加至二甲双胍的治疗组糖化血红蛋白（HbA1c）水平实现了统计学意义的显著更大降幅。3个研究中，saxa/dapa的安全属性与saxagliptin和dapagliflozin已知的安全属性一致。

欧盟委员会（EC）在审查药品时通常都会采纳CHMP的建议，这也意味着saxa/dapa很可能在未来2-3个月获批上市，成为欧洲首个由DPP-4抑制剂和SGLT-2抑制剂（DPP-4i/SGLT-2i）组成的糖尿病复方药。

原始出处：

Positive CHMP opinion in EU for saxa/dapa (saxagliptin and dapagliflozin) for adults with type-2 diabetes

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2016-12-28 tulenzi

#SGLT#

76 0
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2016-09-16 fmq_28614553

#SGLT-2#

95 0
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2016-05-30 minlingfeng

#降糖药#

65 0
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02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401932, encodeId=406d140193278, content=<a href='/topic/show?id=7ff0621125' target=_blank style='color:#2F92EE;'>#DPP-4#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6211, encryptionId=7ff0621125, topicName=DPP-4)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJmFzSicR3biaepTGaMtOl8hS8SjNQ92YP4GmFUlefPkcPnZJWBsHM057ogFrQEPrgdTgPrlxG70KYA/132, createdBy=eeb42370314, createdName=gaoxiaoe, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448609, encodeId=f7631448609d3, content=<a href='/topic/show?id=b374162192f' target=_blank style='color:#2F92EE;'>#SGLT-2i#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, 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2016-05-30 医生2394

#CHMP#

76 0
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2016-05-30 12498b3em08(暂无昵称)

#APA#

75 0
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02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401932, encodeId=406d140193278, content=<a href='/topic/show?id=7ff0621125' target=_blank style='color:#2F92EE;'>#DPP-4#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6211, encryptionId=7ff0621125, topicName=DPP-4)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJmFzSicR3biaepTGaMtOl8hS8SjNQ92YP4GmFUlefPkcPnZJWBsHM057ogFrQEPrgdTgPrlxG70KYA/132, createdBy=eeb42370314, createdName=gaoxiaoe, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448609, encodeId=f7631448609d3, content=<a href='/topic/show?id=b374162192f' target=_blank style='color:#2F92EE;'>#SGLT-2i#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, 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2016-05-30 ms9474365431325850

#欧洲#

74 0
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objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1380265, encodeId=caa91380265ed, content=<a href='/topic/show?id=f19c644e3c0' target=_blank style='color:#2F92EE;'>#沙格列汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64473, encryptionId=f19c644e3c0, topicName=沙格列汀)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b3e473, createdName=pyaili, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401932, encodeId=406d140193278, content=<a href='/topic/show?id=7ff0621125' target=_blank style='color:#2F92EE;'>#DPP-4#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6211, encryptionId=7ff0621125, topicName=DPP-4)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJmFzSicR3biaepTGaMtOl8hS8SjNQ92YP4GmFUlefPkcPnZJWBsHM057ogFrQEPrgdTgPrlxG70KYA/132, createdBy=eeb42370314, createdName=gaoxiaoe, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448609, encodeId=f7631448609d3, content=<a href='/topic/show?id=b374162192f' target=_blank style='color:#2F92EE;'>#SGLT-2i#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16219, encryptionId=b374162192f, topicName=SGLT-2i)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=69885414022, createdName=lvygwyt2783, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=)]
2016-05-30 pyaili

#沙格列汀#

130 0
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createdBy=0a3a2500014, createdName=fmq_28614553, createdTime=Fri Sep 16 03:05:00 CST 2016, time=2016-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270832, encodeId=b66b12e083216, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302639, encodeId=c4e01302639d3, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338148, encodeId=37cd133814840, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338967, encodeId=52ac133896e12, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1380265, encodeId=caa91380265ed, content=<a href='/topic/show?id=f19c644e3c0' target=_blank style='color:#2F92EE;'>#沙格列汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64473, encryptionId=f19c644e3c0, topicName=沙格列汀)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b3e473, createdName=pyaili, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401932, encodeId=406d140193278, content=<a href='/topic/show?id=7ff0621125' target=_blank style='color:#2F92EE;'>#DPP-4#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6211, encryptionId=7ff0621125, topicName=DPP-4)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJmFzSicR3biaepTGaMtOl8hS8SjNQ92YP4GmFUlefPkcPnZJWBsHM057ogFrQEPrgdTgPrlxG70KYA/132, createdBy=eeb42370314, createdName=gaoxiaoe, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448609, encodeId=f7631448609d3, content=<a href='/topic/show?id=b374162192f' target=_blank style='color:#2F92EE;'>#SGLT-2i#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16219, encryptionId=b374162192f, topicName=SGLT-2i)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=69885414022, createdName=lvygwyt2783, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=)]
2016-05-30 gaoxiaoe

#DPP-4#

65 0
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createdBy=0a3a2500014, createdName=fmq_28614553, createdTime=Fri Sep 16 03:05:00 CST 2016, time=2016-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1270832, encodeId=b66b12e083216, content=<a href='/topic/show?id=4066981e99e' target=_blank style='color:#2F92EE;'>#降糖药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98179, encryptionId=4066981e99e, topicName=降糖药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302639, encodeId=c4e01302639d3, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338148, encodeId=37cd133814840, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338967, encodeId=52ac133896e12, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1380265, encodeId=caa91380265ed, content=<a href='/topic/show?id=f19c644e3c0' target=_blank style='color:#2F92EE;'>#沙格列汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64473, encryptionId=f19c644e3c0, topicName=沙格列汀)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b3e473, createdName=pyaili, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1401932, encodeId=406d140193278, content=<a href='/topic/show?id=7ff0621125' target=_blank style='color:#2F92EE;'>#DPP-4#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6211, encryptionId=7ff0621125, topicName=DPP-4)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJmFzSicR3biaepTGaMtOl8hS8SjNQ92YP4GmFUlefPkcPnZJWBsHM057ogFrQEPrgdTgPrlxG70KYA/132, createdBy=eeb42370314, createdName=gaoxiaoe, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448609, encodeId=f7631448609d3, content=<a href='/topic/show?id=b374162192f' target=_blank style='color:#2F92EE;'>#SGLT-2i#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=104, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16219, encryptionId=b374162192f, topicName=SGLT-2i)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=69885414022, createdName=lvygwyt2783, createdTime=Mon May 30 02:05:00 CST 2016, time=2016-05-30, status=1, ipAttribution=)]
2016-05-30 lvygwyt2783

#SGLT-2i#

104 0

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阿斯利康降糖药saxa/dapa（沙格列汀/达格列净）获欧盟CHMP支持批准，将成欧洲DPP-4i/SGLT-2i降糖药

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