FDA approves Tanzeum for use in Type 2 Diabetes - GlaxoSmithKline
The FDA has approved Tanzeum (albiglutide), from Glaxo Smith Kline, for injection, for subcutaneous use, as a once-weekly treatment for Type 2 Diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus.
The FDA 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.
Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy (REMS), required by the FDA to ensure that the benefits of Tanzeum outweigh the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis. Following this approval by the FDA, GSK anticipates the US launch of Tanzeum in the third quarter of 2014. Albiglutide was licensed by the European Medicines Agency in March 2014, under the brand name Eperzan.
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