GSK糖尿病药物未能胜过Takeda药物Actos

2013-07-03 yangtao 生物谷

制药巨头GSK公司治疗二型糖尿病的GLP-1受体拮抗剂类药物albiglutide相关研究数据在周一公布。研究人员在和最近公布的其他公司的糖尿病药物对比中发现,albiglutide的药效和Merck公司的Januvia以及Sanofi公司的Lantus、Amaryl等药物相当,但落后于Takeda公司的Actos。数据还显示在降低血糖方面albiglutide逊于Novo的同类产品Victo

制药巨头GSK公司治疗二型糖尿病的GLP-1受体拮抗剂类药物albiglutide相关研究数据在周一公布。研究人员在和最近公布的其他公司的糖尿病药物对比中发现,albiglutide的药效和Merck公司的Januvia以及Sanofi公司的Lantus、Amaryl等药物相当,但落后于Takeda公司的Actos。数据还显示在降低血糖方面albiglutide逊于Novo的同类产品Victoza。

目前,几大公司推出的GLP-1受体拮抗剂类药物都在申请获得上市批准。

详细英文报道:

CHICAGO--GlaxoSmithKline's ($GSK) experimental diabetes drug proved to be at least as good at controlling blood sugar as most--but not one--in a series of late-stage trials reported Monday, building on a body of mixed performances in clinical trials of the weekly therapy.

The London-based drug giant has already requested approval of the GLP-1 receptor agonist, called albiglutide, in the United States and Europe. Regulators have already approved three other GLP-1 drugs, including Novo Nordisk's ($NVO) Victoza, Bristol-Myers Squibb ($BMY) and AstraZeneca's ($AZN) Byetta/Bydureon and Sanofi's ($SNY) Lyxumia. That puts pressure on Glaxo to distinguish its own contender in the crowded field.

Glaxo's albiglutide showed non-inferiority on the blood-glucose score to Merck's ($MRK) Januvia as well as Sanofi's Lantus and Amaryl. But not to Takeda's oral drug Actos, which is now generic and available on the cheap. And one miss out of 5 would seem more impressive had Eli Lilly's ($LLY) similar drug, dulaglutide, not outshone all active comparator drugs in a slate of trials reported here at the American Diabetes Association's annual meeting in recent days, including Byetta.

In a previous late-stage study, Glaxo's drug fell short of the glucose-lowering effects of Novo's daily GLP-1 drug Victoza, which is the biggest seller in the class. Lilly's similar drug is in a late-stage study to compare its safety and effectiveness to Victoza, with results expected in the next 6 months or so.

Glaxo has also fallen short in some comparisons of the safety of albiglutide to other diabetes drugs, and the side effect profile was hoped to be one of ways the program might set itself apart from the rest of the pack. However, the late-stage studies reported over the past several days show that patients on GSK's therapy suffered more gastrointestinal side effects than patients on Actos, Januvia and Lantus.

"The data suggest that albiglutide is unlikely to be sufficient for it to be a serious competitor in the market," Sam Fazeli, a London-based analyst at Bloomberg Industries, as quoted by the company's news wire. "There is a small risk that the regulators would say that the the risk-benefit profile isn't supportive of approval."

As previously reported, Glaxo's pharma R&D chief, Patrick Vallance, acknowledged in a Bloomberg interview that albiglutide would find plenty of company in a "crowded" market for GLP-1 drugs.

Yet regulators are likely to review no fewer than three new GLP-1 drugs this year as Lilly, GSK and Sanofi seek approvals for their contenders. And Lilly's dulaglutide is the only one of the three that has show comparable effectiveness to Victoza.

"The new guy on the block, or the new agent in the armamentarium is looking to be dulaglutide, and the data are looking better than the other ones because the glycemic control is looking to be on par with Victoza 1.8 mg dose," Mads Krogsgaard Thomsen, Novo's chief scientific officer, said in an interview with FierceBiotech on Sunday.

As Bloomberg reported, analysts have relatively low expectations for Glaxo's drug with a consensus estimate of $301 million in sales by 2016. That number pales in comparison to the blockbuster sales of Victoza and revenue from Byetta and its long-acting version Bydureon.

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1862737, encodeId=56591862e371c, content=<a href='/topic/show?id=0b69542242' target=_blank style='color:#2F92EE;'>#CTO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5422, encryptionId=0b69542242, topicName=CTO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c66088, createdName=gao_jian4217, createdTime=Wed Mar 12 02:03:00 CST 2014, time=2014-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1779005, encodeId=e2081e79005e5, content=<a href='/topic/show?id=e94f19102d' target=_blank style='color:#2F92EE;'>#Actos#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1910, encryptionId=e94f19102d, topicName=Actos)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=052a130, createdName=yyj062, createdTime=Fri Apr 11 18:03:00 CST 2014, time=2014-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507529, encodeId=9a5e150e529d6, content=<a href='/topic/show?id=5c491e1055a' target=_blank style='color:#2F92EE;'>#Takeda#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17105, encryptionId=5c491e1055a, topicName=Takeda)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=68059907531, createdName=qindq, createdTime=Fri Jul 05 13:03:00 CST 2013, time=2013-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1584051, encodeId=42cc158405183, 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=22, 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=Fri Jul 05 13:03:00 CST 2013, time=2013-07-05, status=1, ipAttribution=)]
    2014-03-12 gao_jian4217
  2. [GetPortalCommentsPageByObjectIdResponse(id=1862737, encodeId=56591862e371c, content=<a href='/topic/show?id=0b69542242' target=_blank style='color:#2F92EE;'>#CTO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5422, encryptionId=0b69542242, topicName=CTO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c66088, createdName=gao_jian4217, createdTime=Wed Mar 12 02:03:00 CST 2014, time=2014-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1779005, encodeId=e2081e79005e5, content=<a href='/topic/show?id=e94f19102d' target=_blank style='color:#2F92EE;'>#Actos#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1910, encryptionId=e94f19102d, topicName=Actos)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=052a130, createdName=yyj062, createdTime=Fri Apr 11 18:03:00 CST 2014, time=2014-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507529, encodeId=9a5e150e529d6, content=<a href='/topic/show?id=5c491e1055a' target=_blank style='color:#2F92EE;'>#Takeda#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17105, encryptionId=5c491e1055a, topicName=Takeda)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=68059907531, createdName=qindq, createdTime=Fri Jul 05 13:03:00 CST 2013, time=2013-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1584051, encodeId=42cc158405183, 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=22, 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=Fri Jul 05 13:03:00 CST 2013, time=2013-07-05, status=1, ipAttribution=)]
    2014-04-11 yyj062
  3. [GetPortalCommentsPageByObjectIdResponse(id=1862737, encodeId=56591862e371c, content=<a href='/topic/show?id=0b69542242' target=_blank style='color:#2F92EE;'>#CTO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5422, encryptionId=0b69542242, topicName=CTO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c66088, createdName=gao_jian4217, createdTime=Wed Mar 12 02:03:00 CST 2014, time=2014-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1779005, encodeId=e2081e79005e5, content=<a href='/topic/show?id=e94f19102d' target=_blank style='color:#2F92EE;'>#Actos#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1910, encryptionId=e94f19102d, topicName=Actos)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=052a130, createdName=yyj062, createdTime=Fri Apr 11 18:03:00 CST 2014, time=2014-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507529, encodeId=9a5e150e529d6, content=<a href='/topic/show?id=5c491e1055a' target=_blank style='color:#2F92EE;'>#Takeda#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17105, encryptionId=5c491e1055a, topicName=Takeda)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=68059907531, createdName=qindq, createdTime=Fri Jul 05 13:03:00 CST 2013, time=2013-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1584051, encodeId=42cc158405183, 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=22, 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=Fri Jul 05 13:03:00 CST 2013, time=2013-07-05, status=1, ipAttribution=)]
    2013-07-05 qindq
  4. [GetPortalCommentsPageByObjectIdResponse(id=1862737, encodeId=56591862e371c, content=<a href='/topic/show?id=0b69542242' target=_blank style='color:#2F92EE;'>#CTO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5422, encryptionId=0b69542242, topicName=CTO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c66088, createdName=gao_jian4217, createdTime=Wed Mar 12 02:03:00 CST 2014, time=2014-03-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1779005, encodeId=e2081e79005e5, content=<a href='/topic/show?id=e94f19102d' target=_blank style='color:#2F92EE;'>#Actos#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1910, encryptionId=e94f19102d, topicName=Actos)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=052a130, createdName=yyj062, createdTime=Fri Apr 11 18:03:00 CST 2014, time=2014-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507529, encodeId=9a5e150e529d6, content=<a href='/topic/show?id=5c491e1055a' target=_blank style='color:#2F92EE;'>#Takeda#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17105, encryptionId=5c491e1055a, topicName=Takeda)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=68059907531, createdName=qindq, createdTime=Fri Jul 05 13:03:00 CST 2013, time=2013-07-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1584051, encodeId=42cc158405183, 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=22, 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=Fri Jul 05 13:03:00 CST 2013, time=2013-07-05, status=1, ipAttribution=)]

相关资讯

葛兰素史克(GSK)正在调查论文涉嫌造假事件

    关于葛兰素史克(GlaxoSmithKline PLC,GSK)中国研发中心涉嫌论文造假事件的提问时,GSK承认其正在“针对一篇学术论文被举报造假一事展开内部调查”。     GSK在电子邮件中说:“我们对这类问题非常重视,研究的真实性对于我们的工作有着极其重要的意义,我们正在想尽一切办法全面调查此事。”GSK表示,公司

GSK着眼于将旗下白血病药物Arzerra打造为一线药物

葛兰素史克表示,公司基于积极的III期临床试验结果,将以一线治疗药物提交旗下慢性淋巴细胞白血病(CLL)药物Arzerra的上市申请。公司表示,Arzerra(奥法木单抗)与苯丁酸氮芥(瘤可宁)联合用药在有447名患者参与的临床研究中达到了其改善无进展生存期(PFS)的主要疗效指标,为接下来几个月内向欧洲、美国及其它地区提交上市申请打下了良好基础。 Arzerra是一种全人源化靶向抗CD20单克

臧敬五“造假”事件再起波澜,第-作者声明是内部斗争的结果

声明 本人(刘学彬)以第一作者身份于 2010 年在《Nature Medicine》上发表了有关“白细胞介素7(IL-7)对TH17细胞的存活和扩增作用”一文,但最近却被人恶意抹黑而引起广泛热议。以致 GSK 组成由律师参与的调查组展开调查,对此我声明如下: 1、本人是该文的第一作者,至始至终参与实验设计,指导课题组展开实验活动,负责整理各种数据及完成论文初稿写作。臧敬五先生作为该文的通

FDA拟重新审议GSK糖尿病药物文迪雅的安全性

     美国联邦卫生顾问小组将于6月份对葛兰素史克旗下糖尿病药物文迪雅(Avandia)的安全性数据予以重新审议,尽管GSK于近日声称,它已不再寻求使之广泛应用于临床。     010年9月份,美国食品药品管理局(FDA)出于对文迪雅心脏病发作和死亡有关的安全性考虑,对该产品的使用设置了严重限制,只允许文迪雅

GSK暂停治疗多发性硬化症实验化合物的人体试验

葛兰素史克(GlaxoSmithKline, GSK)今天宣布,已暂停在人类志愿者身上试验一种治疗多发性硬化症的实验化合物,此前在科学论文中造假的指控导致该公司解雇其在中国的顶级研究员。 这家英国公司表示,正在复核 GSK 2618960 的数据,这是一种处于早期临床试验阶段的化合物,其作用机理在《自然医学》(Nature Medicine)杂志2010年发表的一篇论文中得到阐述。 3 月下旬

GSK糖尿病新药albiglutide结果喜忧参半

GSK公司日前公布了其研发的GLP-1类糖尿病药物albiglutide的相关研究报告。研究数据显示,对比Merck公司的Januvia和Sanofi公司的Amaryl,该种药物能够更有效的降低血糖。但数据同时显示其肠胃副反应的风险也有所增高 详细英文报道: As has often been the case with GlaxoSmithKline's ($GSK) candidate