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Expanded Labelling for Januvia Approved by European Commission
Merck Sharp & Dohme (MSD) today announced that the European Commission has approved 'Januvia' (sitagliptin) for two additional uses for patients with type 2 diabetes. This now makes sitagliptin the only dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor) approved as an add-on therapy to a sulphonylurea ('dual therapy'), or a sulphonylurea plus metformin ('triple therapy'), in the European Union (EU). It remains the only DPP-4 inhibitor indicated for once-daily use.
With this new approval for the two additional uses, the product is now indicated to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control, and when metformin is inappropriate due to contraindications or intolerance; and to improve glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
Sitagliptin was approved in the European Union in March 2007 for the treatment of type 2 diabetes in combination with either metformin or, in certain patients, with a PPAR(gamma) agonist (i.e. thiazolidinedione) when diet and exercise plus either agent do not provide adequate glycaemic control. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
"The approval of these new indications is another step forward in helping to combat type 2 diabetes. It is important because it provides physicians and patients with more options to achieve reduced glycaemic levels," said Stefan Oschmann, President, Europe, Middle East, Africa and Canada, Merck & Co., Inc.
The approval of the indication extensions was based on phase III clinical trial results supporting the tolerability and efficacy of sitagliptin 100 mg once-daily in combination with glimepiride (a sulphonylurea) alone or with glimepiride plus metformin.(1) Overall, the trial data showed that the addition of sitagliptin significantly reduced HbA1c levels and fasting plasma glucose levels, and was generally well tolerated.(1)
In clinical trials in combination with a sulphonylurea (glimepiride), with or without metformin, sitagliptin demonstrated an overall incidence of adverse reactions higher than that seen with placebo, in part related to a higher incidence of hypoglycaemia with the treatment compared to placebo (12.2 percent vs. 1.8 percent, respectively). The higher rate of hypoglycaemia is commonly seen when antihyperglycaemic agents are used in combination with sulphonylurea agents. When sitagliptin is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
In controlled clinical studies in combination therapy with metformin or pioglitazone, the overall incidence of adverse reactions, hypoglycaemia, and discontinuation of therapy due to clinical adverse reactions with sitagliptin were similar to placebo. In these clinical studies, the most common adverse reactions reported (greater than or equal to 5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache.