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Genzyme gets positive opinion for European approval of Renvela for kidney disease patients.

The Genzyme Corporation, Cambridge, MA, announced that the European Medicines Agency's Committee for Medicinal Products (CHMP) has adopted a positive opinion for the marketing authorization of the new phosphate binder Renvela for use in patients with chronic kidney disease (CKD), including patients not on dialysis with serum phosphorous levels >1.78 mmol/L. The filing in Europe for Renvela includes both tablet and powder formulations for the control of serum phosphorous in adult hyperphosphatemic CKD patients. The opinion will be forwarded to the European Commission which will make the final authorization. The European Commission generally follows the advice of the CHMP, but is not obligated to do so. A decision from the European Commission is expected by the end of May.

Genzyme says Renvela is a next generation version of Renagel, a calcium-free, metal-free, non-absorbed phosphate binder, and has the added benefit of a carbonate buffer. In a clinical study comparing Renvela with Renagel, both drugs controlled serum phosphorus equally within recommended KDOQI range.

In the US, Genzyme launched Renvela in its tablet formulation for CKD patients on dialysis in March 2008. The company is also seeking approval from the Food and Drug Administration (FDA) for the powder formulation and for the treatment of hyperphosphatemic CKD patients not on dialysis.

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Publication:Transplant News
Date:Apr 1, 2009
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