FDA approves Onglyza for type 2 diabetes

The FDA has approved Onglyza (saxagliptin, from Bristol-Myers Squibb and AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The approval is based on a clinical development program of approximately 5000 patients. Throughout the Phase 3 development program, treatment with Onglyza at all doses produced clinically relevant and statistically significant reductions in all three key measures of glucose control studied – A1C, fasting plasma glucose (FPG) and post-prandial glucose (PPG) – when partnered with other commonly used oral anti-diabetic agents (metformin, sulfonylureas and TZDs), or when used as a monotherapy.

Onglyza is a selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.

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