GlaxoSmithKline readies for filing of diabetes drug albiglutide on positive final data
UK pharma giant GlaxoSmithKline (LSE: GSK) says that positive data from the Phase III Harmony 8 study and from the event driven meta-analysis for assessment of cardiovascular safety conducted across the albiglutide clinical program are the final elements required to complete the clinical registration package for its type 2 diabetes drug candidate.
With these data now available and anticipating completion of the chemistry and manufacturing package in the next few months, GSK says it intends to commence global regulatory submissions for its investigational glucagon-like peptide-1 (GLP-1) receptor agonist 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.
Modest sales expectations
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