Novartis’ Galvus gains monotherapy licence in Europe

Novartis' type 2 diabetes drug Galvus (vildagliptin) has extended its European license to add a monotherapy indication.

The drug is now available for patients who cannot take metformin and who are unable to control their blood sugar with diet and exercise alone.

Previously the drug had only been available in combination with other treatments, such as metformin, a sulphonylurea (if metformin is inappropriate) or a thiazolidinedione in patients with insufficient glycaemic control.

This new indication means Galvus offers greater competition to Merck & Co's fellow DPP-IV inhibitor Januvia (sitagliptin), which is also approved as a monotherapy and is the current market leader in its class.

The drugs work by blocking production of the enzyme DPP-IV, which plays a major role in glucose metabolism.

Other DPP-IV inhibitors include Bristol-Myers Squibb/AstraZeneca's Onglyza (saxagliptin), although the drug is currently only approved as an add-on therapy in Europe.

The new Galvus approval gives people with type 2 diabetes who are unable to take metformin due to intolerance or contraindication an alternative treatment option.

According to Novartis, this accounts for a quarter of Europe's 47m type 2 diabetes patients.

The approval was based on clinical studies involving more than 3,000 patients that demonstrated patients taking Galvus had improved glycaemic control and was well-tolerated by patients.

In the last few months, the drug has gained European approval to treat patients with type 2 diabetes who have either moderate or severe renal impairment.

It was also approved in China, where the country's diabetes population is approaching 100m people, in January, 2012, as an add-on treatment to metformin.

However, Galvus still has no licence in the US in any indication after Novartis withdrew its application to the Food and Drug Administration in 2008 due to the regulator's demands for additional clinical data.