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Genzyme gets European approval for treating CKD patients with Renvela; positive opinion for marketing Mozobil.

Genzyme Corporation, Cambridge, MA, announced the European Commission (EC) has approved Renvela for the control of serum phosphorus in patients with chronic kidney disease (CKD). The approval includes patients not on dialysis with serum phosphorus levels >1.78 mmol/L, and covers both the tablet and powder formulations.

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 filter. The company says in clinical study comparing Renvela to Renagel both controlled serum phosphorus equally to within the recommended KDOQI range.

The company is seeking worldwide approvals for Renvela. The drug has been approved in India, Brazil and the US.

In late May the European Medicines Agency's Committee for Human Medicinal Products adopted a positive opinion on the marketing authorization application for Mozobil. In the EU, Mozobil would be indicated in combination with granulocyte-colony stimulating factor to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilze poorly.

Genzyme says it plans to submit additional approval applications in up to 60 countries.

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Publication:Transplant News
Date:Jun 1, 2009
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