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FDA Approves Avapro (Irbesartan) For The Treatment Of Diabetic Nephropathy (Kidney Disease) In Patients With High Blood Pressure And Type 2 Diabetes

Bristol-Myers Squibb Company (NYSE: BMY) and Sanofi-Synthelabo (Euronext: SAN; NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Avapro® (irbesartan) for a new indication: the treatment of diabetic nephropathy (kidney disease) in people who have hypertension and type 2 diabetes.

 In the United States, approximately 50 million people suffer from high blood pressure and approximately 17 million from diabetes. An estimated one third of patients with diabetes will develop chronic kidney failure,(1) which requires dialysis or a kidney transplant. Avapro, an angiotensin II receptor blocker (ARB) was originally approved by the FDA in 1997 for use in treating high blood pressure (hypertension).

 “The FDA approval of Avapro for this new indication marks an important advance in the treatment of patients with high blood pressure, type 2 diabetes and kidney disease,” said Edmund Lewis, MD, professor of nephrology and director of the Section of Nephrology at Rush Medical College in Chicago, Illinois. “As a result of this decision physicians now have a new option to help manage this serious condition that affects millions of Americans.”

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