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GSK向FDA提交糖尿病药物albiglutide BLA

来源:生物谷 2013-01-15 02:32

2013年1月14日讯 /生物谷BIOON/ --葛兰素史克(GSK)宣布,已向FDA提交了albiglutide的生物许可证申请(BLA),该药与诺和诺德的Victoza、百时美施贵宝(BMS)和阿斯利康(AstraZeneca)Amylin单元的Byetta及Bydureon属于同一类注射型人胰升血糖素样肽-1(GLP-1)药物。GSK称,将在近期向EMA提交该药的监管申请。

Albiglutide为GLP-1受体激动剂,这是一种实验性生物制品,用于2型糖尿病的治疗,每周皮下注射1次。(生物谷bioon.com)

英文原文:GlaxoSmithKline said on Monday it had filed for U.S. approval of its new once-weekly diabetes drug albiglutide and would make a similar submission shortly in Europe as it vies for a share of a crowded market.

Albiglutide belongs to the same class of injectable GLP-1 medicines as Victoza, from Novo Nordisk, and Byetta and Bydureon, from Bristol-Myers Squibb and AstraZeneca's Amylin unit.

The submission by GSK, Britain's biggest drugmaker, was in line with its plan to seek regulatory approval for the new product in 2013. As a latecomer to the GLP-1 market, however, analysts believe albiglutide may struggle to generate major sales.

Consensus forecasts for albiglutide currently point to modest annual sales of around $367 million by 2017, according to Thomson Reuters Pharma.

Albiglutide is one of a number of new drugs GSK hopes will revive its product portfolio. It is also hoping for approval of the two lung drugs, Relvar and Anoro; an HIV medicine called dolutegravir; and two melanoma drugs dabrafenib and trametinib.

Further ahead, GSK expects to have pivotal clinical trial results on up to 14 medicines in the next two years, including two potentially ground-breaking experimental drugs for heart disease and cancer - darapladib and MAGE-A3.

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