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Sitagliptin Recommended for Approval in the European Union for the Treatment of Type 2 Diabetes

January 25, 2006 -- Januvia (sitagliptin), Merck, Sharp & Dohme's treatment for patients with type 2 diabetes, today received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) in Europe. The CHMP opinion recommends that JANUVIA be approved in the European Union for the treatment of type 2 diabetes. Following the conclusion of the CHMP review, the opinion for JANUVIA will be transmitted to the European Commission (EC). If the EC adopts the opinion, JANUVIA will be the first and only prescription medication in a new class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors, which enhance the body's own ability to lower blood sugar (glucose) when it is elevated. The decision will be applicable to the 27 countries that are members of the European Union, including the United Kingdom, Germany, France, Italy and Spain. JANUVIA is currently approved in eleven countries including the United States and Mexico. Marketing authorization from the European Commission is expected in early April after the adoption of the opinion.

The CHMP, comprised of regulators from all European Union countries, gave the positive opinion following a review of comprehensive data supporting the efficacy and safety and tolerability profile of JANUVIA. The submission package consisted of studies involving approximately 4,000 patients with type 2 diabetes treated with JANUVIA.

JANUVIA has been investigated in patients with type 2 diabetes to improve glycaemic control in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycaemic control. JANUVIA has also been studied as add on therapy with PPAR gamma agonists in patients with type 2 diabetes mellitus in whom use of a PPAR gamma agonist (e.g. a thiazolidinedione) is appropriate. In addition, JANUVIA has been studied as monotherapy in many patients.

In a clinical study, JANUVIA plus metformin, compared to treatment of a sulfonylurea (SU) plus metformin, showed comparable glucose lowering efficacy. In this study patients taking JANUVIA plus metformin lost weight (-1.5 kg) compared to patients taking glipizide plus metformin who gained weight gain (+1.1 kg). Hypoglycaemia (when blood sugar becomes too low) was more common in patients treated with glipizide plus metformin (32 percent) compared to patients treated with JANUVIA plus metformin (4.9 percent). In the overall phase III clinical programme the incidence of hypoglycaemia in patients taking JANUVIA was similar to patients taking placebo (1.2 percent, JANUVIA vs. 0.9 percent, placebo). In clinical trials of up to 2 years in duration, patients have received treatment with JANUVIA alone or in combination with metformin, a sulfonylurea (with or without metformin) or a PPAR gamma agent. In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8 percent with JANUVIA and 1.5 percent with other treatments. No adverse reactions considered as drug-related were reported in patients treated with JANUVIA occurring in excess (> 0.2 % and difference > 1 patient) of that in patients treated with control. Reported adverse events included nausea (common), somnolence, upper abdominal pain, diarrhoea and hypoglycaemia (uncommon).** JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

JANUVIA (sitagliptin) is an oral, once daily, potent and highly selective DPP-4 inhibitor. DPP-4 inhibitors work by enhancing a natural body process that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase the release of insulin and signal the liver to reduce its production of glucose. DPP-4 inhibitors enhance the body's own ability to control blood sugar levels by increasing the active levels of these incretin hormones in the body, helping to decrease blood sugar levels in patients with type 2 diabetes.

Source: Merck

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