The FDA has approved Bristol-Myers Squibb (BMS) and AstraZeneca's Onglyza (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults for the treatment of type 2 diabetes mellitus.
Onglyza once daily can be used in combination with commonly prescribed oral anti-diabetic medications--metformin, sulfonylureas or thiazolidinediones (TZD)--or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels, according to the New York City-based BMS and London-based AstraZeneca.
Based on its indications, Onglyza should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. Onglyza has not been studied in combination with insulin.
The approval is based on a clinical development program, which included approximately 5,000 individuals, more than 4,000 of whom received Onglyza. As part of the development program, Onglyza, with diet and exercise, was studied as add-on therapy with other oral anti-diabetic medications, including metformin, the sulfonylurea glyburide and TZDs; in adult patients new to diabetes therapy starting metformin and Onglyza together; and as a monotherapy, according to the companies.
In the Phase III development program, treatment with Onglyza at all doses produced statistically significant reductions in the three key measures of glucose control studied--A1C, fasting plasma glucose and post-prandial glucose--when partnered with other commonly used oral anti-diabetic agents (metformin, sulfonylureas and TZDs) or when used as a monotherapy, the companies said. Onglyza was weight and lipid neutral compared with a placebo.