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 per cent as measured by HbA1c, 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 hypoglycaemia side effects (i.e. dangerously low blood sugar) than other type 2 diabetes medicines such as sulfonylureas or thiazolidinediones.
"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 James Shannon, MD, global head of development at Novartis Pharma AG. "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".
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.
"With Eucreas, patients who are not reaching their blood sugar goals on metformin alone will have an effective and well tolerated treatment option to gain better blood sugar control," said Prof Emanuele Bosi, director of the diabetes and endocrinology unit at San Raffaele University Hospital in Milan, Italy.