US Prescription Drug User Fee Act (PDUFA) goal date for GlaxoSmithKline (GSK) drug albiglutide has been extended to April 15
Singapore: GlaxoSmithKline (GSK) highlighted 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.
This step has been taken in order to provide time for a full review of information submitted by GSK in response to the FDA's requests.
GSK announced the submission of a biologics licence application to the US FDA for albiglutide on January 14, 2013, and this was followed by the submission of a marketing authorization application to the European Medicines Agency (EMA) on March 7, 2013.
The EMA filing is progressing to schedule. Albiglutide is not approved for use anywhere in the world.
