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FDA delays decision on new diabetes drug from GSK

GlaxoSmithKline has announced that it will have to wait a few more months to find out whether its experimental diabetes drug albiglutide has been approved for the US market.
The British drugmaker revealed on Friday that the U.S Food and Drug Administration (FDA) had asked for more time to review the information on albiglutide submitted by GSK in response to the health regulator’s initial queries.
As a result, the deadline for a final FDA decision on the drug has been delayed by three months until April 15, 2014.
However, a separate application with the European Medicines Agency for the use of albiglutide in Europe is progressing on schedule, GSK said.
Albiglutide is a once-weekly treatment for type 2 diabetes that belongs to the same class of injectable GLP-1 medications as Novo Nordisk’s Victoza, Sanofi’s Lyxumia, and Byetta and Bydureon from Bristol-Myers Squibb / AstraZeneca .

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