Eucreas a step nearer European approval
pharmafile | October 11, 2007 | News story | Sales and Marketing |Â Â Â
Novartis' new combination drug, Eucreas, is set for approval following recommendation from Europe's medicines regulator.
Eucreas is a single-tablet combination of Galvus and metformin for the treatment of type II diabetes. Data show patients inadequately controlled on metformin, a commonly prescribed oral treatment for diabetes, are four times more likely to achieve blood sugar control with the addition of Galvus compared to placebo.
Galvus received final EU approval in September, and the combination drug approval will help it compete in the growing diabetes market, in which treatment with multiple agents is an established feature.
James Shannon, Global Head of Development at Novartis, said: "With a significant proportion of type II 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 is one in a new class of drugs called DPP-4 inhibitors that work by increasing and prolonging the action of natural hormones in the body, known as incretins. These decrease blood sugar by increasing consumption of sugar by the body, mainly through increasing the production of insulin in the pancreas and reducing production of sugar by the liver.
The first DPP-4 inhibitor to reach global markets was Merck's Januvia, first launched in the US market in late 2006.
Prof Emanuele Bosi, Director of the Diabetes & Endocrinology Unit at San Raffaele University Hospital in Milan, Italy, said: "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 II diabetes."
The European Commission is expected to issue an official decision on Eucreas by the end of 2007, which could make Eucreas the first single-tablet combination of a DPP-4 inhibitor and metformin in the EU.
