Onglyza, made by Bristol-Myers Squibb and distributed by Bristol-Myers Squibb and AstraZeneca Pharmaceuticals, was tested in diabetes patients at relatively low risk of heart disease. The FDA approval requires Bristol-Myers Squibb to conduct a postmarketing study to evaluate the drug's heart safety in higher-risk patients.
Onglyza carries the generic name saxagliptin. It belongs to a class of type 2 diabetes drugs called DPP-4 inhibitors. The first drug in this class, Merck's Januvia, was approved in 2006. Like Onglyza, Januvia is taken once daily and is to be used in combination with diet and exercise.
Another DPP-4 inhibitor, Takeda's alogliptin, was rejected by the FDA last month. The U.S. regulatory agency said the company has to provide more data on heart risks before it can be approved. Takeda has said these additional studies will take two years.
All DPP-4 inhibitors work the same way, by blocking an enzyme that degrades GLP-1, a short-lived hormone that stimulates insulin release from the pancreas, thereby lowering blood sugar. Patients taking DPP-4 inhibitors have higher GLP-1 levels and lower blood sugar levels.
"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," says Mary Parks, MD, director of the FDA's Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research.
The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.