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FDA approved saxagliptin to treat type 2 diabetes
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Patients with type 2 diabetes now have a new treatment option: saxagliptin, a dipeptidyl peptidase-4 inhibitor that stimulates the pancreas to create more insulin after meals.
Saxagliptin (Onglyza, AstraZeneca and Bristol-Myers Squibb) is intended for use as a once-daily tablet in conjunction with diet and exercise to control high blood glucose levels.
FDA approval was based on the results of eight clinical trials. One, presented in 2008 at the 44th Annual Meeting of the European Association for the Study of Diabetes, concluded that saxagliptin, when used in combination with metformin as initial therapy, produced reductions across all key measures of glucose control in treatment-naïve participants with inadequately controlled type 2 diabetes. After 24 weeks, patients assigned to saxagliptin plus metformin had an HbA1c mean change from baseline of –2.5% vs. –1.7% among patients assigned placebo.
The application seeking FDA approval was submitted before December 2008 when the FDA recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. In April, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-2 that evidence of CV safety with saxagliptin is sufficient to rule out unacceptable, excess CV risk with the drug. Although saxagliptin was not associated with an increased risk for CV events in low-risk patients, the agency is requiring a postmarket study that will specifically evaluate CV safety in patients at higher risk for CV events.
Safety analyses reveal that the most common adverse events reported with saxagliptin are upper respiratory tract infection, urinary tract infection and headache.
The first agent of the DPP-4 inhibitor class — sitagliptin (Januvia, Merck) — was approved by the FDA in 2006. Other drugs in the class include vildagliptin (Galvus, Novartis), for use in the European Union; linagliptin, currently in development (Boehringer Ingelheim); and alogliptin (Takeda), whose FDA application for the product is currently suspended.