Genzyme wins European positive opinion for kidney drug

Genzyme, a biotechnology company, has announced that the European Medicines Agency’s Committee for Human Medicinal Products has adopted a positive opinion for the marketing authorization of the new phosphate binder Renvela for use in patients with chronic kidney disease, including patients not on dialysis, with serum phosphorous levels greater than or equal to 5.5mg/dL.

Genzyme’s filing in Europe for Renvela includes both tablet and powder formulations for the control of serum phosphorus in adult hyperphosphatemic chronic kidney disease (CKD) patients.

The Committee for Human Medicinal Products (CHMP) opinion will be forwarded to the European Commission, which will make a final decision on the authorization. A decision from the European Commission is expected at the end of May 2009.

In the US, Genzyme launched Renvela in its tablet formulation for patients with CKD on dialysis 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.

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