sNDA for Merck & Co's Januvia OKed

The US Food and Drug Administration has approved expanded labeling for drug major Merck & Co's Januvia (sitagliptin), the only DPP-4 inhibitor available in the USA for the treatment of type 2 diabetes, under a supplemental New Drug Application.

The drug is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Januvia has not been studied in combination with insulin. The new regimens described in the updated labeling include, as an adjunct to diet and exercise, initial therapy in combination with metformin; add-on therapy to a sulfonylurea (glimepiride) when the single agent alone does not provide adequate glycemic control; and, add-on therapy to the combination of a sulfonylurea (glimepiride) and metformin when dual therapy does not provide adequate glycemic control.

New data contained in three studies support the efficacy and safety of Januvia. Initial therapy with the combination of the Merck drug and metformin provided substantial A1C reductions. Januvia demonstrated similar efficacy to a sulfonylurea (glipizide) in patients inadequately controlled on metformin. The drug also provided significant placebo-adjusted A1C reductions in patients being treated with a sulfonylurea (glimepiride), with or without metformin.