Genzyme files for FDA approval of new phosphate binder

CAMBRIDGE, Mass.--Genzyme Corp. said today it has filed a New Drug Application with the U.S. Food and Drug Administration for its sevelamer carbonate to be used in chronic kidney disease patients on dialysis.

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

The sevelamer carbonate, branded as Renvela, is intended to control serum phosphorus levels in dialysis patients. Genzyme said Renvela is being developed to replace its existing phosphate binder Renagel. The biopharmaceutical company added that Renvela is a non-calcium, non-metal, non-absorbed phosphate binder that will be available in 800 mg tablets.

Genzyme has also completed enrollment in a study to investigate the use if Renvela in hyperphosphatemic CKD patients not on dialysis. In addition, researchers have completed enrollment in another study to compare Renvela in powder form dosed once daily to Renagel tablets dosed three times a day. Genzyme said a powder form of the treatment would be a more convenient option for the patient that could improve compliance.