MERCK FILES FOR NEW JANUVIA INDICATIONS

Merck announced that the FDA has accepted for standard review two supplemental new drug applications (sNDAs) for Januvia, and the company expects FDA action on both sNDAs by mid-October.

One sNDA supports a proposed new indication for the use of Januvia (sitagliptin), as an adjunct to diet and exercise, in combination with metformin as initial therapy to improve glycemic control. The other sNDA supports 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 glycemic control and as add-on therapy to the combination of a sulfonylurea and metformin when dual therapy does not provide adequate glycemic control.

Januvia was first approved in October 2006 as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones, to improve blood sugar control in patients with Type 2 diabetes when diet and exercise are not enough. The recommended dose of Januvia is 100 mg once daily.