LONDON (Alliance News) - GlaxoSmithKline PLC Tuesday said it has received US approval for once-weekly type 2 diabetes treatment Tanzeum or albiglutide, with the company now anticipating the US launch of the treatment in the third-quarter of 2014.
In a statement, the pharmaceutical giant said the treatment has been approved by the US Food and Drug Administration for injection. In March, Albiglutide was licensed by the European Medicines Agency under the brand name Eperzan, for use in adult patients with type 2 diabetes.
The FDA approved Tanzeum as a complement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Albiglutide, a glucagon-like peptide-1 receptor agonist, is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen.
Glucagon-like peptide-1 is an incretin hormone that helps reduce blood glucose levels but, in people with type 2 diabetes, its production is often reduced or absent.
"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 glucagon-like peptide-1 receptor agonist treatment option for appropriate patients in the US," Vlad Hogenhuis, senior vice-president and head, GSK global cardiovascular, metabolic and neurosciences franchise, said in a statement.
Type 2 diabetes is a life-long, progressive and, in some cases, preventable condition characterized by high blood sugar levels. A lack of physical activity, obesity, increasing age, high blood pressure and genetics are known risk factors that can contribute to the development of type 2 diabetes.
Glaxo said the FDA's approval of albiglutide is based on the results of GSK's comprehensive Phase III Harmony programme, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum.
The Harmony 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.
Glaxo shares Tuesday closed at 1,547.00 pence, up 0.3%.
By Samuel Agini; samagini@alliancenews.com; @samuelagini
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