GENZYME SUBMITS APPLICATION FOR RENAGEL REPLACEMENT

Genzyme announced it has filed a new drug application (NDA) with the FDA seeking approval of sevelamer carbonate for the control of serum phosphorus in patients with chronic kidney disease on dialysis. The drug will be marketed under the name Renvela.

Renvela is being developed as a next-generation phosphate binder to replace Renagel (sevelamer HCl), the most-prescribed phosphate binder in the U.S., according to the company. Like Renagel, Renvela is a non-calcium, nonmetal, non-absorbed phosphate binder and will be available in 800-mg tablets.

In addition to the NDA 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 with Renagel tablets dosed three times a day. Development of a powder form of the product would offer a more convenient option for patients, Genxyme said.