Bristol-Myers Squibb and AstraZeneca have announced the FDA’s approval of saxagliptin (Onglyza), a dipeptidyl peptidase-4 (DPP-4) inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. DPP-4 inhibitors stimulate the pancreas to make more insulin after meals. Merck’s Januvia is the only other DPP-4 inhibitor on the market.
Taken once daily, saxagliptin can be used alone or with other oral antidiabetic, such as metformin, sulfonylureas, or thiazolidinediones (TZDs). It should not be prescribed for patients with type-1 diabetes or diabetic ketoacidosis.
When saxagliptin is administered with strong cytochrome P450 3A4 and 3A5 inhibitors such as ketoconazole drug (Nizoral, Janssen), the dose should be limited to 2.5 mg. No dose adjustments are required based on sex, race, weight, or hepatic impairment.
Sources: FDA, July 31, 2009; Fierce-Biotech, August 3, 2009