Genzyme introduces Renvela in US for dialysis patients

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Mar 07, 2008 (M2 EQUITYBITES via COMTEX) -- GENZ | news | PowerRating | PR Charts -- Biotechnology company Genzyme Corp (Nasdaq: GENZ | news | PowerRating | PR Charts ) declared on 6 March the launch of the phosphate binder Renvela (sevelamer carbonate) for dialysis patients in the US plus significant progress in its international efforts to secure additional approvals for the product.

Genzyme has also announced the submission of a marketing authorisation application to the European Medicines Agency for Renvela (tablet and powder formulations) for the control of serum phosphorus in chronic kidney disease patients regardless of whether they are on dialysis. The first EU launch of Renvela is anticipated in the third quarter of 2009.

Genzyme also applied for the approval of Renvela tablets for dialysis patients in the key South American market of Brazil late in 2007 and will continue to pursue additional approvals internationally.

The company is engaged in active discussions with the US Food and Drug Administration to expand Renvela's labelling to include chronic kidney disease patients with hyperphosphatemia who are not on dialysis.

Renvela is a next-generation version of Renagel (sevelamer hydrochloride), allegedly the most-prescribed phosphate binder in the United States. It is indicated in patients with chronic kidney disease on dialysis.

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