GlaxoSmithKline (GSK) has secured FDA approval for Albiglutide(Tanzeum), a once-weekly GLP-1 agonist that helps spur the body's natural insulin production in patients with Type 2 diabetes.

The FDA 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 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. Following this approval by the FDA, GSK anticipates the US launch of Tanzeum in the third quarter of 2014.

Albiglutide was approved last month in the European Union under the name Eperzan. In the US, it joins other GLP-1 agonists already on the market, including liraglutide (Victoza, Novo Nordisk) and exenatide (Byetta, AstraZeneca/Bristol-Myers Squibb). Another GLP-1 agonist waiting in the wings is Lilly's dulaglutide.