FDA Okays Broader Use for Sitagliptin (Januvia) in Type 2 Diabetes

WHITEHOUSE STATION, N.J., Oct. 18 -- Sitagliptin (Januvia), a DDP-4 inhibitor used in treatment of type 2 diabetes, has been approved for use in combination or add-on regimens, according to a release from the drug's manufacturer, Merck.
In October 2006, the FDA approved sitagliptin as an adjunct to diet and exercise to improve glycemic control in adults. The new labeling extends approval to permit use of sitagliptin in combination with metformin as initial therapy and as add-on therapy for patients who do not achieve glycemic control with sulfonylurea monotherapy or with the combination of sulfonylurea and metformin.
The drug maker said the FDA approved the expanded labeling after reviewing results of three studies that examined the efficacy of sitagliptin in combination regimens.
In addition to the expanded indications, the company said it will update the warnings and precautions on the label to include information about hypersensitivity based on post-marketing reports. The label will include a warning that the drug is contraindicated in patients with a history of serious hypersensitivity to sitagliptin, including anaphylaxis and angioedema.
Exfoliative skin conditions including Stevens-Johnson syndrome were also reported among patients taking the drug.
The recommended dose of sitagliptin is 100 mg once a day for all approved indications, except in patients with moderate or severe renal insufficiency or end-stage renal disease. For those with moderate insufficiency the recommended dose is 50 mg once a day and for those with severe insufficiency or ESRD, the dose is 25 mg once daily.