FDA pushes review of GSK’s diabetes drug back

GlaxoSmithKline’s approval review date for its diabetes drug has been pushed back by three months by the US Food and Drug Administration (FDA).

The US Prescription Drug User Fee Act goal date for albiglutide is now set for April 15th 2014. This provides extra time for a full review of information submitted by GSK in response to the FDA’s requests.

Albiglutide is an investigational once-weekly treatment for adult patients with type 2 diabetes. It belongs to the same class of injectable GLP-1 drugs as Novo Nordisk’s Victoza and Byetta / Bydureon from the R&D alliance between Bristol-Myers Squibb and AstraZeneca.

Albiglutide is not approved for use anywhere in the world.


Related news:

GlaxoSmithKline diabetes drug faces U.S. approval delay (Reuters)

Reference links:

GSK press release

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