GlaxoSmithKline has received positive data from the phase III Harmony 8 study for albiglutide in type 2 diabetes and from the event driven meta-analysis for assessment of cardiovascular safety conducted across the albiglutide clinical programme.
These data are the final elements required to complete the clinical registration package.
With these data now available and anticipating completion of the chemistry and manufacturing package in the next few months, GSK intends to start global regulatory submissions for its investigational glucagon-like peptide-1 (GLP-1) receptor agonist albiglutide for the treatment of type 2 diabetes in early 2013.
Albiglutide is not yet approved as a treatment for type 2 diabetes or any other indication anywhere in the world.
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