Genzyme Seeks To Expand Use of Phosphate Binders in CKD

Genzyme Corp. and the FDA’s Cardiovascular and Renal Products Advisory Committee will meet to consider the use of phosphate binders in patients with chronic kidney disease (CKD) who are not on dialysis.
   
The FDA has also requested that Shire and Fresenius — companies that currently market phosphate binders for patients on dialysis — provide information that will help the agency make a decision regarding the use of phosphate binders in CKD.     
   
In a briefing package provided to the FDA, the companies have outlined the following arguments in favor of the expanded use: phosphate imbalance precedes the need for dialysis in patients with CKD, and should be treated at the time that patients begin to experience hyperphosphatemia; left untreated, patients experiencing hyperphosphatemia prior to the initiation of dialysis may experience progression of renal disease, bone disorders and vascular calcification; hyperphosphatemia is an independent risk factor for cardiovascular morbidity and mortality, and for the progression of renal failure in the pre-dialysis population; and the risk-benefit profile of early treatment of hyperphosphatemia in CKD patients not on dialysis is favorable.