FDA approves Genzyme's Renvela

WASHINGTON Genzyme’s phosphate binder Renvela, used to control serum phosphorus in patients with chronic kidney disease (CKD), has been approved by the Food and Drug Administration.

Renvela (sevelamer carbonate) will be used for both peritoneal dialysis and hemodialysis. The company said it plans to file for approval of Renvela in earlier stages of CKD as it prepares to launch the drug during the first quarter of 2008.

The drug has the same active ingredient as Renagel, which is the most prescribed phosphate binder in the U.S. Both products share the same indications as well. Renagel’s approved uses were expanded recently to include patients on peritoneal dialysis.

Both drugs control serum phosphorus, considered a biomarker for treatment of patients with CKD. However, patients on Renvela are more likely to maintain bicarbonate levels within recommended ranges and have lower incidences of gastrointestinal adverse events.

Renagel had sales of $145 million during the second quarter of 2007, the company said.

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