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EASD: Eucreas, a Combination of Galvus and Metformin, Recommended for Approval 

Sep 25, 2007

Type 2 diabetes patients failing to achieve recommended glycemic goals despite high doses of metformin, are four times more likely to reach recommended targets by adding the DPP-4 inhibitor vildagliptin (Galvus) to their metformin regimen. Following EU approval, Eucreas will be first single-tablet combination of a DPP-4 inhibitor and metformin .

About one-third of patients given a combination of metformin and vildagliptin (Galvus) achieved a glycosylated hemoglobin (HbA1c) level of less than 7%, compared with 9.4% of patients given metformin and a placebo, said investigators at an industry sponsored symposium at the European Association for the Study of Diabetes meeting.

Novartis has received a positive opinion recommending European Union approval for Eucreas®, an oral tablet combining Galvus® (vildagliptin) and metformin, as a new treatment for patients with type 2 diabetes. Following approval, Eucreas will be the first single-tablet combination of a DPP-4 inhibitor and metformin approved in the EU.

The positive opinion for Eucreas was issued by the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines for the European Commission (EC). The Commission generally follows the CHMP’s recommendations and is expected to issue a decision within three months.

The recommendation was based on data showing additional robust reductions in blood sugar when Galvus, a member of a new class of diabetes medicines called DPP-4 inhibitors, was added to metformin – one of the most prescribed oral anti-diabetes therapies. In clinical studies, Galvus administered in combination with metformin resulted in additional blood sugar reductions of 1.1% as measured by HbA1c[1], the gold standard measure of blood sugar control.

Importantly for patients, Galvus, when added to metformin, is also well tolerated. In clinical trials, the addition of Galvus to metformin provided robust blood sugar control without weight gain and with fewer hypoglycemia side effects (i.e. dangerously low blood sugar) than other type 2 diabetes medicines such as sulfonylureas or thiazolidinediones.

Galvus received a positive opinion from the CHMP in July 2007 recommending European approval as an add-on to the most common oral anti-diabetes medicines, with the broadest range of indications for any drug in the DPP-4 class.

Eucreas has been recommended 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 Galvus/850 mg metformin or 50 mg Galvus/1000 mg metformin.

Prof Emanuele Bosi, Director of the Diabetes & Endocrinology Unit at San Raffaele University Hospital in Milan, Italy. added: "In clinical studies, Galvus added to metformin demonstrates additional significant blood sugar reductions and is well tolerated. The combination of Galvus and metformin does not cause weight gain and has a low incidence of hypoglycemia, the two most common side effects of current treatments for patients with type 2 diabetes."

Data presented earlier this week at the European Association for the Study of Diabetes (EASD) congress demonstrated that patients inadequately controlled on metformin are four times more likely to achieve blood sugar control with the addition of Galvus compared to placebo (or sugar pill).

A study of 544 patients with type 2 diabetes who were inadequately controlled on metformin showed that 35.5% achieved glycemic control (HbA1c < 7.0%) when Galvus was added to metformin, compared to 9.4% of those receiving metformin with placebo.
Eucreas combines two agents to provide robust blood sugar control by increasing insulin, decreasing glucagon and targeting insulin resistance. Galvus works through a novel mechanism of action by targeting the dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes. Metformin works mainly by decreasing the production of sugar by the liver and increasing insulin sensitivity. In Eucreas, Galvus and metformin work to restore the natural function of the body in controlling blood sugar.

The drug Galvus is not approved for use in the U.S. Last February, the FDA asked Novartis to submit more data in order to obtain approval.

European Association for the Study of Diabetes (EASD) meeting