Reuters logo
4 years ago
GlaxoSmithKline diabetes drug faces U.S. approval delay
August 2, 2013 / 2:35 PM / 4 years ago

GlaxoSmithKline diabetes drug faces U.S. approval delay

1 Min Read

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

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below