CAMBRIDGE, Mass.—Genzyme Corp. said Jan. 14 that it’s working with physicians to transition all U.S. patients on the phosphate binder Renagel to Renvela by Sept. 30.
Renvela was launched in March 2008 and is a next-generation version of Renagel, which Genzyme said is the most-prescribed phosphate binder in the United States.
“We developed Renvela because we are committed to improving the care of kidney disease patients,” said Dan Regan, senior vice president of Genzyme’s U.S. renal business. “We believe that Renvela is the best option for patients who need a phosphate binder, and this is why we are working to fully transition all appropriate patients to this treatment.”
Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed treatment approved for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renvela, however, has a carbonate buffer.
Renagel and Renvela are protected by the same core patents, which expire in 2014, according to Genzyme. The company added that Renvela has comparable managed care coverage to Renagel, and is widely available through the majority of commercial insurance and Medicare Part D plans.
In addition, Genzyme said it is continuing to work with the U.S. Food and Drug Administration toward a label expansion in mid-2009 for Renvela to include the treatment of hyperphosphatemic chronic kidney disease patients who are not on dialysis.
Renvela and Renagel are both currently available in tablet form, and Genzyme said it anticipates that it will launch a powder form of Renvela in the United States in mid-2009 for the control of serum phosphorus in chronic kidney disease patients on dialysis.
The Renvela powder formulation will provide an additional therapeutic option for physicians and a no-pill phosphate binder option for patients, according to Genzyme. European approval of Renvela is also expected by the middle of this year, and Genzyme is pursuing approvals in other markets internationally.
