Genzyme's Renvela gets nod for expanded EU label

US biotechnology major Genzyme's Renvela (sevelamer carbonate) has been recommended for approval for chronic kidney disease by the European  Medicine Agency's (EMEA) Committee for Medicinal Products for Human Use  (CHMP).

Renvela, 800mg film-coated tablets and 1.6g and 2.4g powder for oral  suspension, was given the go-ahead for the control of hyperphosphataemia  in adult patients receiving hemodialysis or peritoneal dialysis. Renvela  is also indicated for the control of hyperphosphatemia in adult patients  with chronic kidney disease not on dialysis with serum phosphorus above  1.78mmol/L.

The phosphate binder contains multiple amines separated by one carbon  from the polymer backbone. These amines become partially protonated in  the intestine and interact with phosphate ions through ionic and  hydrogen bonding thus lowering the phosphate concentration. Sevelamer  decreases the incidence of hypercalcaemic episodes as compared to  patients using calcium-based phosphate binders alone, probably because  the product itself does not contain calcium, Genzyme noted.