Two supplemental New Drug Applications (sNDAs) for Januvia (sitagliptin) have been accepted for review, and Merck expects FDA action by October.
One sNDA proposes a new indication for using Januvia, in conjunction with diet and exercise, as initial combination therapy with metformin for improving glycemic control. The other sNDA is filed in support of two proposed new indications for use of the drug as add-on therapy to either a sulfonylurea or the combination of a sulfonylurea plus metformin when these agents do not provide adequate glycemic control.
Januvia’s current indication is for use as monotherapy and as add-on therapy to either metformin or thiazolidinediones to improve blood glucose control in patients with type 2 diabetes when diet and exercise are not sufficient. The recommended dose of Januvia is 100 mg once daily.