FDA approves Onglyza for type 2 diabetes

By David Liu (davidl@foodconsumer.org)

The U.S. Food and Drug Administration (FDA) on Friday July 31 approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. 

Onglyza is not intended to cure type 2 diabetes. Rather, it is intended to be used with diet and exercise to control high blood sugar levels, the FDA says.  

Patients with type 2 diabetes neither produce enough insluin nor utilize insulin effectively to control blood sugar. 

Onglyza is a dipeptidyl peptidase-4 (DPP-4) inhibitor which stimulates the pancreas to make more insulin after eating a meal.

DPP-4 inhibitors are a class of drugs that affect the action of hormones known as incretins, which lower elevated blood sugar levels after meals by increasing insulin production in the pancreas and reducing the production of glucose in the liver.

"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, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. 

"High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease."

Use of Onglyza can result in side effects including upper respiratory tract infection, urinary tract infection, headache, and allergic-like reactions such as rash and hives.

FDA approved the drug primarily based on the results from eight clinical trials.  

The agency in requiring a post-market study to specifically evaluate cardiovascular safety in patients who are at high risk for the cardiovascular events even though the drug does not seem to increase such a risk in the low-risk patients.

Bristol-Myers Squibb Co. of Princeton, N.J., the manufacturer, and AstraZeneca Pharmaceuticals LP, of Wilmington, Del. comarketer, submitted the New Drug Application for Onglyza on June 30th, 2008 to the FDA, according to a statement the drug companies released on July 23 2008.