FDA Approves Saxagliptin for Improving Glycemic Control in Diabetic Patients

Yael Waknine

August 03, 2009

August 3, 2009 — The US Food and Drug Administration (FDA) has approved once-daily saxagliptin tablets (Onglyza, Bristol-Myers Squibb Co, marketed in conjunction with AztraZeneca Pharmaceuticals, LP) for use with diet and exercise to control hyperglycemia in patients with type 2 diabetes mellitus.

The dipeptidyl peptidase-4 inhibitor works by stimulating the pancreas to make more insulin after a meal.

"Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes," said Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research in an agency news release. "High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease."

The FDA's action was primarily based on data from 8 clinical trials. Results showed that saxagliptin was superior to placebo for reducing HbA1c levels, fasting plasma glucose, and postprandial glucose levels in patients with type 2 diabetes mellitus. Likewise, adding saxagliptin to metformin, a sulfonylurea, or a thiazolidinedione lowered HbA1c levels to a greater extent than either of these standard drugs alone.

According to the news release, saxagliptin was not associated with an increased risk for cardiovascular events in low-risk patients. A postmarketing study is planned to evaluate the drug's cardiovascular safety in a higher-risk population that includes sicker and older patients.

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