Genzyme debuts Renvela for US dialysis patients

US biotechnology major Genzyme has launched its phosphate binder Renvela (sevelamer carbonate) for dialysis patients in the USA, and announced progress in its international efforts to secure additional approvals for the product. Renvela is a next-generation version of Renagel (sevelamer HCl), which it says is the most-prescribed phosphate binder in the USA.

Genzyme has submitted a marketing application to the European Medicines Agency (EMEA) seeking approval of Renvela for the control of serum phosphorus in chronic kidney disease patients regardless of whether they are on dialysis. This application, which includes both tablet and powder formulations, must be validated before it will be accepted for review.

The company anticipates that the application will be validated by the end of this month, and the review period is expected to take around 15 months. The first European Union launch of Renvela is anticipated in the third quarter of 2009. Genzyme also applied for approval of Renvela tablets for dialysis patients in the key South American market of Brazil late last year, and will continue to pursue additional clearances internationally.