Merck & Co. Inc, announced that the US Food and Drug Administration (FDA) has accepted for standard review two supplemental New Drug Applications (sNDAs) for Januvia (sitagliptin), and the company expects FDA action on both sNDAs by mid-October.
One sNDA is filed in support of a proposed new indication for the use of Januvia, as an adjunct to diet and exercise, in combination with metformin as initial therapy to improve glycaemia control. The other sNDA is filed in support of two proposed new indications for use of Januvia, as an adjunct to diet and exercise, as add-on therapy to a sulfonylurea when the single agent alone does not provide adequate glycaemia control and as add-on therapy to the combination of a sulfonylurea plus metformin when dual therapy does not provide adequate glycaemia control.
Januvia is currently indicated for use as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise are not enough. The recommended dose of Januvia is 100 mg once daily.
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. In clinical trials, Januvia demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with Januvia (greater than or equal to 5 per cent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache.
"If these sNDAs are approved, the expanded labelling will include indications for use of Januvia as initial therapy with metformin and as add-on to any of the three most commonly prescribed classes of oral antihyperglycemic agents," said John Amatruda, MD, vice president, clinical research, Merck & Co., Inc. "These data further support the broad utility of Januvia as an important treatment option for patients with type 2 diabetes."
Phase III data supporting two sNDAs. The proposed new indication of Januvia in combination with metformin as initial therapy is supported by a 24-week, factorial study in 1,091 randomised patients with type 2 diabetes. Results of this study were presented for the first time at the annual meeting of the European Association for the Study of Diabetes in September 2006.
The recommended dose of Januvia is 100 mg once daily, with or without food, for all approved indications. No dosage adjustment is needed for patients with mild to moderate hepatic insufficiency or in patients with mild renal insufficiency (CrCl greater than or equal to 50 mL/min).