Genzyme Corp., of Cambridge, Mass., has received approval to market Renvela (sevelamer carbonate) for the control of serum phosphorus in dialysis patients.
The drug is a metal-free, calcium-free, non-absorbed phosphate binder and will be available as 800-mg tablets. It is a next-generation version of Renagel (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States, with the added benefit of a carbonate buffer.
In a clinical study comparing the two, Renvela and Renagel controlled serum phosphorus equally to within ranges recommended by Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines. Patients on Renvela, however, had a lower incidence of GI adverse events and were more likely to maintain bicarbonate levels within KDOQI-recommended ranges.
“As we prepare to launch Renvela for patients on dialysis, we will move forward with regulatory filings to gain approval for the product’s use in earlier stages of chronic kidney disease, so that all patients who can benefit from this treatment have access to it,” said John P. Butler, president of Genzyme Renal. Genzyme will continue to make Renagel available, with the long-term goal of transitioning patients to Renvela.