Eucreas, an oral diabetes tablet combining Galvus (vildagliptin) and metformin, has been recommended for use in Europe by the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines for the European Commission.

The European Commission generally follows the CHMP's recommendations, and a decision on the Novartis combination drug is expected before the end of the year. The CHMP in July recommended approval of Galvus, and the European Commission is expected to approve it for sale shortly.

Similar to Merck's Janumet, a combination of Januvia (sitagliptin) and metformin which is already on sale in the United States, Eucreas may become the first single-tablet combination of a DPP-4 inhibitor and metformin approved in the European Union.

The positive recommendation for Eucreas was based on studies showing that was based on data showing that Galvus administered in combination with metformin resulted in additional blood sugar reductions of 1.1% as measured by HbA1c, the leading measure of glucose control.

"The anticipated European approvals of Eucreas and Galvus will allow us to offer new treatment options to patients with type 2 diabetes and to help them gain better blood sugar control," said Dr. James Shannon, Novartis Global Head of Development.

"With a significant proportion of type 2 diabetics still not reaching their blood sugar goals, Eucreas and Galvus have the potential to help millions of patients, and we are committed to making these treatments available as soon as possible," Shannon added.

Data presented at the European Association for the Study of Diabetes (EASD) congress showed that type 2 diabetics who had inadequate blood sugar control on metformin were four times more likely to achieve good glucose control with the addition of Galvus compared to those receiving a placebo.