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GSK receives FDA approval of Tanzeum for adults with type 2 diabetes.
GlaxoSmithKline (GSK) reported that FDA has approved Tanzeum (albiglutide) for injection, as a once-weekly treatment for adults with type 2 diabetes mellitus.
The FDA approval of albiglutide is based on the results of GSK’s Phase III Harmony program, consisting of eight trials and involving over 5000 patients, 2000 of which were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatments, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment.
GSK expects to launch Tanzeum in the third quarter of 2014.