Issue 66 April 2014
7. Drug update
EU recommends approval for Empagliflozin
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (to be marketed under the name Jardiance) for the treatment of adults with type 2 diabetes.

EU approval of empagliflozin is now just a formality and will represent the first approval for this drug worldwide. When approved in Europe, empagliflozin will become the third oral SGLT2 inhibitor available there. The agents work by increasing urinary glucose excretion, with a consequent lowering of plasma glucose levels, which is accompanied by weight loss.

Dapagliflozin was the first of these agents to be approved in the European Union and has also recently been cleared by the FDA. Canagliflozin was the 1st SGLT2 to be approved in the United States, at the end of March 2013, and has also since been approved in the European Union.

Albiglutide approved by US FDA
The US Food and Drug Administration (FDA) has approved TanzeumTM (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum from GlaxoSmithKline has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1), is a biological product for the treatment of type 2 diabetes, administered once-weekly. 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. 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®, for use in adult patients with type 2 diabetes.
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