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news.The FDA has granted marketing approval to Genzyme for its Renvela treatment for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
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Renvela is a next-generation version of Renagel (sevelamer hydrochloride), the most-prescribed phosphate binder in the US. Genzyme expects to launch Renvela for dialysis patients in the US during the Q1 of next year, and is pursuing regulatory approvals in Europe, South America and in other markets internationally. The company will continue to make Renagel available, with the long-term goal of transitioning patients to Renvela.
Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed phosphate binder and will initially be available as 800mg tablets. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally, but patients on Renvela were more likely to maintain bicarbonate levels within the recommended ranges, and had a lower incidence of gastrointestinal adverse events.
John Butler, president, Genzyme Renal, said: “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.”