Global Pharma Management

Genzyme Corporation announced that the European Commission has approved Renvela for the control of serum phosphorus in patients with chronic kidney disease (CKD). The approval includes patients not on dialysis with serum phosphorus levels = 1.78 mmol/L (5.5 mg/dL), and covers both the tablet and powder formulations.

Dan Regan, Senior Vice President and General Manager of Genzyme’s renal business said, With this marketing authorization, Renvela is the first phosphate binder for patients not on dialysis approved through the centralized procedure in Europe.  This is an important step toward improved patient care, and we are pleased that CKD patients in Europe will now have access to this proven therapy.

Renvela is a next-generation version of Renagel® (sevelamer hydrochloride), a calcium-free, metal-free, non-absorbed phosphate binder, and has the added benefit of a carbonate buffer. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally to within the recommended KDOQI range.