CAMBRIDGE, Mass.—The U.S. Food and Drug Administration approved on August 12 a powder form of Genzyme’s phosphate binder Renvela.
The FDA approved the Renvela powder in strengths of 0.8 grams and 2.4 grams to control serum phosphorus in dialysis patients, according to information the FDA’s Web site. Renvela is currently available in 800 mg tablets.
The powder will come in a sachet, which is a small disposable bag, much like a big sugar packet, according to Dan Regan, senior vice president of Genzyme’s U.S. renal business. “You pour it into a couple of ounces of water, stir it up, and then patients can take it rather than taking a pill,” he added.
The citrus-flavored powder was made for patients who may have difficulty swallowing or just prefer a powder over a pill, said Regan.
Regan said that Genzyme is looking to launch the Renvela powder in the fall.
Renvela was launched in March 2008 and is a next-generation version of Renagel. 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.
