Genzyme announced that the company obtained approval in the EU to market the tablet and powder formulations of Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease (CKD), including certain patients not on dialysis. Dan Regan, general manager of Genzyme’s renal business, stated that the marketing authorisation "is the first phosphate binder for patients not on dialysis approved through the centralised procedure in Europe."
In the US, Renvela's tablet formulation is already approved for use in patients with CKD on dialysis, and Genzyme anticipates FDA approval of the powder formulation for this indication in the second half of 2009. The company has also been in discussions with the FDA regarding the treatment of hyperphosphataemic CKD patients not on dialysis, and expects the talks to continue beyond midyear.
The drugmaker is also seeking approval for Renvela in other countries and the company noted that the product was approved last week in Brazil to treat patients with CKD on dialysis.
To read more Top Story articles, click here.