New Type 2 Diabetes Treatment Gets FDA Go-Ahead

2 August 2009 (Last Updated August 2nd, 2009 18:30)

The US Food and Drug Administration (FDA) has approved Onglyza (saxagliptin), a once-daily tablet used to control high blood sugar levels in adults with Type 2 diabetes. Onglyza, manufactured by Bristol-Myers Squibb and marketed by Bristol-Myers and AstraZeneca, is classed as a dipeptidy

The US Food and Drug Administration (FDA) has approved Onglyza (saxagliptin), a once-daily tablet used to control high blood sugar levels in adults with Type 2 diabetes.

Onglyza, manufactured by Bristol-Myers Squibb and marketed by Bristol-Myers and AstraZeneca, is classed as a dipeptidyl peptidase-4 (DPP-4) inhibitor, which stimulates the pancreas to make more insulin after eating a meal.

The drug is intended to be used with diet and exercise to control high blood sugar levels.

FDA Centre for Drug Evaluation and Research director of the division of metabolism and endocrinology products Mary Parks said that controlling blood sugar levels was essential to managing the good health of the 24 million people in the US with Type 2 diabetes.

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

FDA approval was based primarily on the results of eight clinical trials. The FDA also requires a postmarket study to evaluate cardiovascular safety, as the application request was submitted before the FDA issued a ruling that all manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety.

Onglyza has, however, not been associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events. Other side effects observed with Onglyza include upper respiratory tract infection, urinary tract infection, headaches and allergic-like reactions such as rash and hives.