FDA Approves Type 2 Diabetes Drug Onglyza

July 31, 2009
Bradley Schmidt

The Food and Drug Administration approved the Bristol-Myers/AstraZeneca once-daily drug Onglyza for the treatment of Type 2 diabetes in adults.

Individuals suffering from Type 2 diabetes can now count once-daily tablet Onglyza (saxagliptin) as a potential pharmacologic means to glycemic control. The U.S. Food and Drug Administration today approved the drug for treatment of adults.

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

The drug was approved largely as a result of eight Brisotl-Myers and AstraZeneca clinical trials that did not indicate an increased risk for cardiovascular events, an especially important consideration in light of tightened FDA control over risk and diabetes treatment.

A 2007 New England Journal of Medicine article indicated an increased risk of myocardial infarction and death from cardiovascular events associated with GlaxoSmithKline’s Type 2 diabetes drug Avandia after which the FDA was subject to withering criticism over its safety standards.

It makes sense then that the FDA is requiring Bristol-Myers and AstraZeneca to conduct follow-up studies to assess cardiovascular risk in the elderly, those with existing heart conditions and other high-risk patients.

The FDA found the most common side effects to be “upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.”