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Diabetes drug gets good review

The Committee for Medicinal Products for Human use (CHMP) has recommended that a new medicine to treat Type II diabetes be approved for use in Europe.

The Committee for Medicinal Products for Human use (CHMP) has recommended that a new medicine to treat Type II diabetes be approved for use in Europe.

Sitagliptin/metformin has been developed to provide a significant reduction in glucose levels in patients with diabetes. The drug was licensed for use in the UK in 2007 and is manufactured under the brand name Janumet by Merck Sharp & Dhome. The company could potentially be in a position to supply its branded medicine to 27 countries in the European market, including Norway and Iceland, should regulatory authorities adopt CHMP's recommendation.

Kamlesh Khunti, professor of primary care diabetes and vascular medicine at the University of Leicester, said: "Many patients remain poorly controlled on their existing oral combination therapy. In order to improve quality of life for our patients, we need simple and effective treatments that address glucose control and common tolerability issues such as hypoglycaemia and weight gain."

A 30-week placebo-controlled clinical study showed that sitagliptin/metformin had a high level of efficacy when reducing blood sugar levels. A decision regarding marketing authorisation by the European Medicines Agency (EMEA) is expected in mid June 2008.

25th April 2008

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