欧洲药品管理局的CHMP支持诺和诺德口服GLP-1受体激动剂Rybelsus,用于治疗2型糖尿病

2020-02-02 不详 MedSci原创

诺和诺德(Novo Nordisk)宣布,欧洲药品管理局的人用药品管理委员会(CHMP)采纳了一项积极意见,建议批准其口服GLP-1受体激动剂Rybelsus(semaglutide)用于治疗2型糖尿病控制不佳的成年人,作为饮食和运动的辅助手段来改善血糖控制。监管机构指出,该药物是开发用于口服的首个GLP-1受体激动剂治疗药物。

诺和诺德(Novo Nordisk)宣布,欧洲药品管理局的人用药品管理委员会(CHMP)采纳了一项积极意见,建议批准其口服GLP-1受体激动剂Rybelsus(semaglutide)用于治疗2型糖尿病控制不佳的成年人,作为饮食和运动的辅助手段来改善血糖控制。监管机构指出,该药物是开发用于口服的首个GLP-1受体激动剂治疗药物。

特别是,CHMP建议在二甲双胍不合适的情况下,将Rybelsus批准为单一疗法,并与其他药物联合用于治疗2型糖尿病

诺和诺德(Novo Nordisk)首席科学官Mads Krogsgaard Thomsen说:"我们相信Rybelsus有潜力为欧盟制定治疗2型糖尿病的新标准。" 该药物于去年9月获得美国的批准,可作为饮食和运动的辅助手段,改善2型糖尿病成年人的血糖控制。

原始出处:


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createdName=shenxlcyp, createdTime=Wed Jun 17 20:54:00 CST 2020, time=2020-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1294033, encodeId=2f62129403343, 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=30, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302676, encodeId=f3fb13026e600, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339273, encodeId=e39f13392e349, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1422743, encodeId=30ef1422e434c, content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425453, encodeId=02f5142545375, content=<a href='/topic/show?id=b602630980d' target=_blank style='color:#2F92EE;'>#欧洲药品管理局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63098, encryptionId=b602630980d, topicName=欧洲药品管理局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c44f3972955, createdName=isabellayj, createdTime=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1575333, encodeId=bbe015e53331e, content=<a href='/topic/show?id=38058082f9' target=_blank style='color:#2F92EE;'>#GLP-1受体激动剂Rybelsus#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8082, encryptionId=38058082f9, topicName=GLP-1受体激动剂Rybelsus)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=aa0116095386, createdName=刘阔, createdTime=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627806, encodeId=18e4162e8062c, 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=27, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1042956, encodeId=2b0b104295655, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Feb 02 19:54:00 CST 2020, time=2020-02-02, status=1, ipAttribution=)]
    2020-02-04 医生2394
  5. [GetPortalCommentsPageByObjectIdResponse(id=1659408, encodeId=7fea165940870, content=<a href='/topic/show?id=7f998e468c2' target=_blank style='color:#2F92EE;'>#药品管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87468, encryptionId=7f998e468c2, topicName=药品管理)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Sep 05 11:54:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793523, encodeId=c7b91e93523a8, content=<a href='/topic/show?id=d3f915e7391' target=_blank style='color:#2F92EE;'>#Rybelsus#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15773, encryptionId=d3f915e7391, topicName=Rybelsus)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, createdName=shenxlcyp, createdTime=Wed Jun 17 20:54:00 CST 2020, time=2020-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1294033, encodeId=2f62129403343, 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=30, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302676, encodeId=f3fb13026e600, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, 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content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425453, encodeId=02f5142545375, content=<a href='/topic/show?id=b602630980d' target=_blank style='color:#2F92EE;'>#欧洲药品管理局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63098, encryptionId=b602630980d, topicName=欧洲药品管理局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c44f3972955, createdName=isabellayj, createdTime=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1575333, encodeId=bbe015e53331e, content=<a href='/topic/show?id=38058082f9' target=_blank style='color:#2F92EE;'>#GLP-1受体激动剂Rybelsus#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8082, encryptionId=38058082f9, topicName=GLP-1受体激动剂Rybelsus)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=aa0116095386, createdName=刘阔, createdTime=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627806, encodeId=18e4162e8062c, 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=27, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1042956, encodeId=2b0b104295655, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Feb 02 19:54:00 CST 2020, time=2020-02-02, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1659408, encodeId=7fea165940870, content=<a href='/topic/show?id=7f998e468c2' target=_blank style='color:#2F92EE;'>#药品管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87468, encryptionId=7f998e468c2, topicName=药品管理)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Sep 05 11:54:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793523, encodeId=c7b91e93523a8, content=<a href='/topic/show?id=d3f915e7391' target=_blank style='color:#2F92EE;'>#Rybelsus#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15773, encryptionId=d3f915e7391, topicName=Rybelsus)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, 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content=<a href='/topic/show?id=54fa80e701' target=_blank style='color:#2F92EE;'>#GLP-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425453, encodeId=02f5142545375, content=<a href='/topic/show?id=b602630980d' target=_blank style='color:#2F92EE;'>#欧洲药品管理局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63098, encryptionId=b602630980d, topicName=欧洲药品管理局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c44f3972955, createdName=isabellayj, createdTime=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1575333, encodeId=bbe015e53331e, content=<a href='/topic/show?id=38058082f9' target=_blank style='color:#2F92EE;'>#GLP-1受体激动剂Rybelsus#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8082, encryptionId=38058082f9, topicName=GLP-1受体激动剂Rybelsus)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=aa0116095386, createdName=刘阔, createdTime=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1627806, encodeId=18e4162e8062c, 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=27, 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=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1042956, encodeId=2b0b104295655, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Feb 02 19:54:00 CST 2020, time=2020-02-02, status=1, ipAttribution=)]
    2020-02-04 yibei
  7. [GetPortalCommentsPageByObjectIdResponse(id=1659408, encodeId=7fea165940870, content=<a href='/topic/show?id=7f998e468c2' target=_blank style='color:#2F92EE;'>#药品管理#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87468, encryptionId=7f998e468c2, topicName=药品管理)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Sep 05 11:54:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793523, encodeId=c7b91e93523a8, content=<a href='/topic/show?id=d3f915e7391' target=_blank style='color:#2F92EE;'>#Rybelsus#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15773, encryptionId=d3f915e7391, topicName=Rybelsus)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, 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  8. 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  9. 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  10. 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attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=95bc21134754, createdName=medscijoin, createdTime=Tue Feb 04 07:54:00 CST 2020, time=2020-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1042956, encodeId=2b0b104295655, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Feb 02 19:54:00 CST 2020, time=2020-02-02, status=1, ipAttribution=)]
    2020-02-02 misszhang

    谢谢MedSci提供最新的资讯

    0

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欧洲药品管理局(EMA)开始审查Gilead子公司Kite的嵌合抗原受体(CAR)T细胞疗法KTE-X19,用于治疗复发或难治性的套细胞淋巴瘤(MCL)成年患者。

强生向欧洲药品管理局提交申请,寻求扩大其IL-23单抗Tremfya用于治疗银屑病关节炎

强生已向欧洲药品管理局(EMA)提交了II型变更申请,以寻求扩大其白细胞介素-23单抗Tremfya(guselkumab)用于治疗成人活动性银屑病关节炎(PsA)。一旦获批,将成为该药物在欧盟的第二项适应症。

Abeona Therapeutics的ABO-102基因疗法治疗罕见病,获得欧洲药品管理局的PRIME指定

Abeona Therapeutics宣布,欧洲药物管理局(EMA)已授予其ABO-102药物的PRIME称号,ABO-102是以腺相关病毒9(AAV9)为载体的基因疗法,开发用于治疗A型Sanfilippo综合症(MPS IIIA),这是一种罕见的溶酶体贮积病。

欧洲药品管理局批准了Seattle Genetics公司的tucatinib用于局部晚期或转移性HER2阳性乳腺癌患者的市场授权申请

美国Seattle Genetics公司宣布,欧洲药品管理局(EMA)批准tucatinib联合曲妥珠单抗和卡培他滨的市场许可申请书(MAA),用于治疗局部晚期不可切除或转移性HER2阳性乳腺癌的成年患者,包括已经接受了至少两种抗HER2治疗的脑转移患者。

强生的雄激素受体拮抗剂Erleada,获得欧洲药品管理局批准治疗去势敏感型前列腺癌

强生公司(Johnson&Johnson)宣布其选择性雄激素受体(AR)拮抗剂Erleada(apalutamide),获得欧洲药品管理局批准,将适应症扩展用于治疗转移性去势敏感性前列腺癌(mCSPC),此次批准使该药物的适用人群再增加了100000例欧洲患者。

欧洲药品管理局CHMP建议批准7种药物上市和2种药物扩展适应症

欧洲药品管理局的人类用药产品委员会(CHMP)在11月的会议上,建议批准7种药物以及2种药物的扩展。