GlaxoSmithKline is going to have to wait a while yet before it gets the thumbs-up from the US Food and Drug Administration for its investigational diabetes drug albiglutide.
The drugs major has announced that the Prescription Drug User Fee Act (PDUFA) date for albiglutide, a once-weekly GLP-1 receptor agonist, has been extended by three months to April 15, 2014. The delay will provide time "for a full review of information submitted by GSK in response to the FDA’s requests".

GSK filed the drug with the agency in January but in June published data from five Phase III studies which showed albiglutide to be effective in reducing levels of HbA1c. However, in one trail, the treatment failed to show non-inferiority against Takeda's Actos (pioglitazone) in lowering blood glucose.

If approved, albiglutide is entering the crowded GLP-1 marketplace which is dominated by Novo Nordisk's once-a-day Victoza (liraglutide), twice-daily Byetta (exenatide), now marketed by AstraZeneca and Bristol-Myers Squibb, and an extended-release formulation of the latter, Bydureon. Also showing promise in late-stage studies is Eli Lilly's dulaglutide.
GSK noted that its albiglutide submission to the European Medicines Agency in March is progressing to schedule.