The approval comes after Novartis proposed changes to the EU label recommending that liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter. The Eucreas approval closely follows European approval of the updated label for Galvus announced earlier this month.

The decision applies in all 27 countries of the EU as well as in Norway and Iceland, and both medicines will be available in the first European countries within the next few weeks.

Studies show that more than half of patients currently taking medication to manage their type 2 diabetes are still not reaching blood glucose goals[1]. Combination therapy usually becomes necessary due to progressive worsening of blood sugar control during the natural course of the disease[2].

In clinical studies, patients inadequately controlled on metformin, one of the most prescribed oral therapies for type 2 diabetes, were four times more likely to achieve blood sugar control by adding Galvus to their treatment compared to those who added a placebo (or sugar pill)[3]. Furthermore, Galvus when administered with metformin resulted in additional blood sugar reductions of 1.1% as measured by HbA1c[4], the gold standard measure of blood sugar control[5].

"The approval of Eucreas marks an important step forward in the management of type 2 diabetes, as it is the first single-tablet combination of a DPP-4 inhibitor with metformin for patients in Europe," said James Shannon, MD, Chief Medical Officer at Novartis Pharma AG. "The complementary actions of Galvus and metformin, which are the medicines combined in Eucreas, help to bring blood sugar levels under control without the side effects commonly associated with many widely-used type 2 diabetes medicines."

In clinical trials, the addition of Galvus to metformin provided robust blood sugar control without weight gain and with fewer cases of hypoglycemia (i.e. dangerously low blood sugar)[4], side effects associated with other therapies for type 2 diabetes such as sulfonylureas or thiazolidinediones.

Eucreas has been approved for use in type 2 diabetes patients who are inadequately controlled with metformin alone, or are being treated with Galvus and metformin as separate tablets. Eucreas is recommended for use twice-daily at a dose of either 50 mg vildagliptin/850 mg metformin or 50 mg vildagliptin/1000 mg metformin.

Eucreas combines two agents that work together to target both a dysfunction in the pancreatic islets and insulin resistance, two of the main factors contributing to type 2 diabetes. Galvus works through a novel mechanism of action that targets islet dysfunction and restores the body's natural ability to increase insulin and decrease glucagon - the two main hormones controlling blood sugar levels. Metformin works mainly by decreasing the production of sugar by the liver and increasing insulin sensitivity.

Type 2 diabetes is a progressive disease in which control of blood sugar deteriorates over time. If left untreated or not kept under control, it can lead to heart and kidney disease, blindness, and vascular or neurological problems[6].

References
[1] Saydah S, et al. Poor Control of Risk Factors for Vascular Disease Among Adults With Previously Diagnosed Diabetes. JAMA 2004: 291(3): 335-342.
[2] Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 281:2005-2012, 1999.
[3] Dejager S, et al. Achievement of Glycemic Targets with Vildagliptin. Presented at EASD 17-21 September 2007. (Abstract A-07-899).
[4] Bosi E, et al. Effects of Vildagliptin on Glucose Control Over 24 Weeks in Patients With Type 2 Diabetes Inadequately Controlled With Metformin. Diabetes Care. 2007; 30:890-895.
[5] American Diabetes Association. Standards of Medical Care in Diabetes - 2006. http://care.diabetesjournals.org/cgi/content/full/29/suppl_1/s4
[6] International Diabetes Federation Diabetes Atlas. Third edition 2006: http://www.eatlas.idf.org/