FDA finally OKs GlaxoSmithKline's Tanzeum to treat type 2 diabetes

UK pharma giant GlaxoSmithKline (LSE: GSK) yesterday received the much anticipated approval from the US Food and Drug Administration for its Tanzeum (albiglutide), 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 type 2 diabetes mellitus.

The news came after the London Stock Exchange closed, but GSK’s shares moved 1.1% higher to £15.64 as trading resumed this morning.

"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes," said Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, adding: “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”

Following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), albiglutide was approved last month in Europe, where it will be marketed as Eperzan (The Pharma Letter March 27). Analysts expect the drug to generate $430 million in sales by 2018, according to Thomson Reuters research.