US PDUFA for GSK diabetes drug delayed

3 August 2013

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed on Friday (August 2) that the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes, has been extended by three months to April 15, 2014 to provide time for a full review of information submitted by GSK in response to the Food and Drug Administration’s requests.

Albiglutide is not approved for use anywhere in the world, although GSK announced the submission of a Biologics License Application to the FDA for albiglutide on January 14, 2013 and this was followed by the submission of a Marketing Authorization Application to the European Medicines Agency on March 7 this year. The EMA filing is progressing to schedule, the company noted.

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