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news.Genzyme's recently completed study of the drug Renvela achieved its primary endpoint, demonstrating a statistically significant reduction in serum phosphorus for chronic kidney disease patients.
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Patients treated with Renvela also achieved a significant reduction in calcium-phosphorus product and in LDL cholesterol. The drug was well tolerated with a safety profile consistent with the clinical experience of patients on dialysis using Renagel. These results represent one portion of a comprehensive clinical program for Renvela.
Renvela is a buffered form of Renagel, the most-prescribed phosphate binder in the US. Renvela will initially be available as 800mg tablets once approved. A new drug application for Renvela is currently under review by the FDA for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
The National Kidney Foundation has recommended Renagel as a first-line treatment option to control phosphorus. Renagel is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation.