European regulators have given US biotechnology group Genzyme permission to market Renvela for the control of serum phosphorus in patients with chronic kidney disease, giving doctors a new option in the battle against hyperposphataemia.

Specifically, the European Commission has issued a green light for both tablet and powder formulations of the drug, which is a next-generation version of the firm’s phosphate binder Renagel (sevelamer hydrochloride), to be used in patients not yet receiving dialysis with serum phosphorus levels less than or equal to 1.78 mmol/L.

Hyperphosphatemia is caused by the inability of diseased kidneys to filter out phosphorous from the body, leading to excess levels causing calcification of tissues and leaving patients at greater risk from developing heart disease. If left untreated, the condition can also cause bone pain, skeletal deformities and fractures, and so maintaining optimal levels of serum phosphorous is an important element in the care of patients with CKD, the firms notes.

Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride) are currently the only phosphate binders available that do not contain either calcium or a metal, and regulatory approval was based on clinical studies demonstrating the drugs’ ability to control levels of phosphate so that they remain within the recommended range.

According to Dan Regan, Senior Vice President and General Manager of Genzyme’s renal business, the green light for Renvela in Europe marks an important step towards improving the care of patients with CKD, as the drug is the first phosphate binder for cleared through the centralised procedure to treat patients not on dialysis, and so offers doctors now have the opportunity to treat the condition much earlier than before.