Friday, August 2, 2013
GlaxoSmithKline diabetes drug faces U.S. approval delay
The GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013.
Credit: Reuters/Luke MacGregor
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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