Genzyme applies for kidney drug approval
Genzyme Corp, a Cambridge biotechnology company, said today that it has filed a new drug application with the Food and Drug Administration that seeks approval of sevelamer carbonate for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
The plan is to market sevelamer carbonate under the trade name of Renvela, Genzyme said.
One of Genzyme's best selling drugs is Renagel, which prevents dangerous buildup of phosphate in the bloodstreams of kidney-dialysis patients and which Genzyme says is the most prescribed phosphate binder in the United States.
Renvela is being developed as a next generation phosphate binder to replace Renagel, Genzyme said.
Genzyme also said it is advancing a clinical program investigating the use of Renvela for hyperphosphatemic patients with chronic kidney disease who have not progressed on dialysis.
(By Chris Reidy, Globe staff)
