The once-weekly treatment of albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1), is administered using an injector pen supplied with a 5mm 29-gauge thin-walled needle.
GLP-1 is an important incretin hormone that helps reduce blood glucose levels but, in people with type 2 diabetes, its production is often reduced or absent.
GSK senior vice-president and head of Global Cardiovascular, Metabolic and Neurosciences Franchise Vlad Hogenhuis said many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels.
"We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US," Hogenhuis said.
The approval of albiglutide is based on the results of GSK's comprehensive Phase III Harmony program, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum.
The studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment.
Following the FDA approval, the company intends launch Tanzeum in the US in the third quarter of 2014.
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