Based on positive clinical trial results, GSK will seek FDA approval of once-weekly diabetes drug

GlaxoSmithKline (GSK) today announced that topline results have been received from seven of the eight ‘Harmony’ Phase III studies investigating the use of albiglutide in type 2 diabetes.  Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist. GSK has now reviewed primary endpoint data (6 months to 2 years) on the efficacy and safety of albiglutide, verses placebo and active controls, across seven Phase III studies.  Based on these data, a better understanding of the profile of albiglutide in type 2 diabetes is emerging. The data reviewed to date support progression to regulatory submissions, as a possible once-weekly treatment for type 2 diabetes. As well as the full data set from Harmony 6, 7 and 8 and the 2 year data currently in-house from the five ongoing studies, a meta-analysis of cardiovascular safety data will be required to complete the registration package, consistent with FDA guidelines.