January 14, 2013 / 11:26 AM / 7 years ago

GSK files for U.S. approval of new diabetes drug

LONDON (Reuters) - 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.

Reporting by Ben Hirschler

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