Genzyme receives positive opinion for European approval of Renvela for patients with kidney disease

Published: 25-Mar-2009

The European Medicines Agency\'s Committee for Human Medicinal Products (CHMP) has adopted a positive opinion for the marketing authorisation of the phosphate binder Renvela (sevelamer carbonate) for use in patients with chronic kidney disease (CKD).


The European Medicines Agency's Committee for Human Medicinal Products (CHMP) has adopted a positive opinion for the marketing authorisation of the phosphate binder Renvela (sevelamer carbonate) for use in patients with chronic kidney disease (CKD).

Genzyme's filing in Europe for Renvela includes both tablet and powder formulations for the control of serum phosphorus in adult hyperphosphatemic CKD patients. The CHMP opinion will be forwarded to the European Commission, which will make a final decision on authorisation by the end of May.

"We are delighted with this positive opinion," said John Butler, president of Cardiometabolic & Renal at Genzyme. "If confirmed by the European Commission, this will be the first phosphate binder for patients not on dialysis approved through the centralised procedure. This is an acknowledgement of the value Renvela is expected to bring to patients with CKD."

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.

Genzyme launched Renvela in its tablet formulation for patients with CKD on dialysis in the US in March 2008. The company is also seeking FDA approvals of the powder formulation and for the treatment of hyperphosphatemic CKD patients not on dialysis.

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