FDA panel recommends wider use of Genzyme kidney drugs

The FDA's Cardiovascular and Renal Products Advisory Committee voted eight to four, with one abstaining, to recommend that the FDA extend the indications phosphate binders, including Genzyme’s Renagel, to use in pre-dialysis patients with hyperphosphatemia.

The FDA also is expected to rule this month on a New Drug Application seeking marketing approval for the use of Genzyme’s Renvela in patients on dialysis, according to the Cambridge, Mass.-based pharmaceutical company. Genzyme also plans to pursue approval of Renvela for hyperphosphatemic patients with chronic kidney disease (CKD), who are not on dialysis.