Genzyme gets positive opinion for European approval of Renvela for kidney disease patients.
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.
Contact: Web site: www.genzyme.com
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|Date:||Apr 1, 2009|
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