FDA Approves Genzyme's Renvela For Dialysis Patients

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Renvela For Dialysis Patients

FDA has granted marketing approval for Genzyme's Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renvela is a next-generation version of Renagel (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States.

"Since its approval in 1998, Renagel has made an important difference for hundreds of thousands of patients around the world. Today's approval of Renvela -- an improved form of Renagel -- is a key milestone in our ongoing effort to innovate on behalf of patients," said John P. Butler, president, Genzyme Renal. "As we prepare to launch Renvela for patients on dialysis, we will move forward with regulatory filings to gain approval for the product's use in earlier stages of chronic kidney disease, so that all patients who can benefit from this treatment have access to it."

Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed phosphate binder and will initially be available as 800mg tablets. Renvela offers all of the advantages of Renagel with the added benefit of a carbonate buffer. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally to within KDOQI recommended ranges. Patients on Renvela, however, were more likely to maintain bicarbonate levels within the recommended KDOQI ranges, and had a lower incidence of gastrointestinal adverse events.

Genzyme expects to launch Renvela for dialysis patients in the United States during the first quarter of next year, and is pursuing regulatory approvals in Europe, South America and in other markets internationally. The company will continue to make Renagel available, with the long-term goal of transitioning patients to Renvela.

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"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 accumulation. The National Kidney Foundation's 2003 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Bone Metabolism and Disease in CKD recommend sevelamer as a first-line treatment option to control phosphorus. Sevelamer hydrochloride is currently used by more than 350,000 patients worldwide.

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