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Renvela

Generic name: sevelamer carbonate
Treatment for: Hyperphosphatemia of Renal Failure

Update: Renvela Now FDA Approved - October 19, 2007

Genzyme Files for Approval of Sevelamer Carbonate for Patients on Dialysis

CAMBRIDGE, Mass., December 21, 2006 -- Genzyme Corp. announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration seeking approval of sevelamer carbonate for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Sevelamer carbonate will be marketed under the trade name Renvela.

Renvela is being developed as a next generation phosphate binder to replace Renagel (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States. Genzyme is seeking approval for use of Renvela in patients with chronic kidney disease (CKD) on dialysis. Like Renagel, Renvela is a non-calcium, non-metal, non-absorbed phosphate binder and will be available in 800mg tablets.

"Submission of this NDA marks an important milestone as we prepare to introduce our next generation of sevelamer," said John P. Butler, president, Genzyme Renal. "Development of this therapy demonstrates our commitment to meeting the needs of all patients who can benefit from using sevelamer."

In addition to today's filing, Genzyme is advancing a clinical program investigating the use of Renvela for hyperphosphatemic patients with chronic kidney disease who have not progressed to dialysis. Enrollment has been completed in the study evaluating Renvela for this indication.

Enrollment is also complete in a study comparing a powder form of sevelamer carbonate dosed once a day to Renagel tablets dosed three times a day. Development of a powder form of the product would offer a more convenient option for patients, thereby improving compliance.

About Renagel

Renagel controls serum phosphorus in patients with CKD on hemodialysis. Controlling serum phosphorus is an important element in the care of hemodialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular mortality. Renagel provides the added benefit of significant LDL cholesterol reduction (32 percent).

The National Kidney Foundation's 2003 K/DOQI guidelines for Bone Metabolism and Disease in Chronic Kidney Disease recommend sevelamer hydrochloride as a first-line treatment option to control phosphorus. Renagel 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. Renagel is used by more than 350,000 people worldwide.

Product Information

Renagel is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on hemodialysis. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. In a 52-week study, the most common side effects included vomiting, nausea, diarrhea, and dyspepsia. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renagel.

For more information about Renagel, including complete prescribing information, please visit www.renagel.com.

Source: Genzyme

Posted: December 2006

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