FDA approves Avapro for treatment of diabetic kidney disease in people with high bloo...( (PRINCETON NJ and PARIS FRANCE Septe...),Health

(PRINCETON, NJ and PARIS, FRANCE, September 18, 2002) Bristol-Myers Squibb Company (NYSE:BMY) and Sanofi-Synthelabo, Inc. (NYSE:SNY and Paris Bourse: Sicovam code 12057) announced today that the U.S. Food and Drug Administration (FDA) has approved Avapro (R) (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, 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."

The FDA approval is based on results from the Irbesartan Diabetic Nephropathy Trial (IDNT) which studied patients with high blood pressure, type 2 diabetes and evidence of kidney disease. Data from the IDNT trial, published in The New England Journal of Medicine, demonstrated that when these patients were treated with Avapro there was a reduction in the risk of their kidney disease progressing, or death, that was 20 percent lower than the placebo (control) group (p=0.02) and 23 percent lower than the group treated with amlodipine, a calcium-channel blocker (p=0.006).

"As a result of the IDNT trial, we have more data supporting the importance of early treatment of diabetic kidney disease," added Dr. Lewis.
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18-Sep-2002

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