said Monday it received approval from the Food and Drug Administration to market Renvela, the next-generation version of Renagel, for the control of serum phosphorus in patients with chronic kidney disease.
The company plans to launch Renvela for dialysis patients in the U.S. during the first quarter of next year and is pursuing regulatory approvals in Europe, South America and in other markets internationally. Genzyme is also moving forward with filings for Renvela for patients in earlier phases of kidney disease.
Renagel will still be available, though Genzyme's long-term goal is to transition patients to Renvela. In clinical trials, patients on Renvela had a lower incidence of adverse gastrointestinal events and were more likely to maintain bicarbonate levels in the recommended range.
Shares were up 66 cents, or 0.9%, to $72.26 in recent trading Monday.