CAMBRIDGE, Mass.—Genzyme Corp. said today that the U.S. Food and Drug Administration has approved its drug Renvela to control serum phosphorus levels in kidney disease patients on dialysis.
“Today’s approval of Renvela—an improved form of Renagel—is a key milestone in our ongoing effort to innovate on behalf of patients,” Genzyme Renal President John Butler said in a statement. “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.”
Phosphate binders are used to treat hyperphosphatemia, which is when the body contains too much phosphorus. The condition is common in kidney disease patients as the kidneys can no longer filter out the excess phosphorus.
Genzyme is referring to Renvela as the next-generation version of Renagel, which was approved by the FDA in 1998 to treat phosphorus levels in dialysis patients. Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed phosphate binder, according to Genzyme. The difference between the two drugs is that Renvela has a carbonate buffer.
Genzyme said it expects to launch Renvela in the United States during the first quarter of 2008, and the drug will initially be available in 800 mg tablets. The company is also attempting to get regulatory approval for Renvela in Europe, South America and other international markets.
Last week, an FDA advisory panel voted to recommend that the federal agency expand the use of phosphate binders in kidney disease patients not on dialysis. As a result, Genzyme said is plans to file a supplemental New Drug Application in the first half of 2008 to non-dialysis kidney disease patients. In addition, Genzyme said it expects to seek approval for a powder form of Renvela.
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