FDA Approves Genzyme's Renvela(TM) for Dialysi... (d in other markets internationally.The c...)

FDA Approves Genzyme's Renvela(TM) for Dialysis Patients

Date:10/22/2007

d in other markets internationally. The company will continue to make Renagel available, with the long-term goal of transitioning patients to Renvela.

"Renvela's approval represents an important advance for chronic kidney disease patients," stated Craig Langman, M.D., the Isaac A. Abt M.D. professor of kidney diseases, Feinberg School of Medicine, Northwestern University. "It is an improved version of a well-established product that has been shown to provide significant advantages to patients."

During the first half of next year, Genzyme also plans to file a supplemental New Drug Application with the FDA seeking approval of Renvela for hyperphosphatemic patients with chronic kidney disease who are not on dialysis. In addition, Genzyme expects to file for approval of a powder form of Renvela that may make it easier for patients to comply with their prescribed treatment program.

Renagel in Peritoneal Dialysis

The FDA also recently approved a label extension for Renagel for the control of serum phosphorus for patients on peritoneal dialysis. The treatment had previously been approved in the U.S. only for patients on hemodialysis. The Renvela approval announced today includes patients on both types of dialysis.

About Renagel and Renvela

Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate) both control serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Controlling serum phosphorus is an important element in the care of dialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular morbidity and mortality. Sevelamer provides the added benefit of significant LDL cholesterol reduction.

Sevelamer is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal a
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FDA Approves Genzyme's Renvela(TM) for Dialysi...(d in other markets internationally.The c...)