GlaxoSmithKline diabetes drug faces U.S. approval delay

LONDON Fri Aug 2, 2013 10:30am EDT

The GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013. REUTERS/Luke MacGregor

The GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013.

Credit: Reuters/Luke MacGregor

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LONDON (Reuters) - U.S. regulators have pushed back an approval decision on GlaxoSmithKline's experimental diabetes drug albiglutide by three months until April 15, 2014, Britain's biggest drugmaker said on Friday.

A separate filing for the drug in Europe is progressing on schedule.

The once-weekly treatment for type 2 diabetes belongs to the same class of injectable GLP-1 drugs as Victoza, from Novo Nordisk, and Byetta and Bydureon, from Bristol-Myers Squibb and AstraZeneca.

Based on reported clinical trial results, industry analysts have questioned how well albiglutide will fare in a crowded market - especially with a promising new rival in the pipeline in the form of Eli Lilly's dulaglutide.

(Reporting by Ben Hirschler; Editing by Keith Weir)

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