FDA's CRDAC votes to expand P binders in CKD

A majority of the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted to recommend the use of phosphate binders, including Shire's non-calcium Fosrenol (lanthanum carbonate), to treat hyperphosphatemia in chronic kidney disease Stage 4 patients. Currently, Fosrenol is indicated to reduce serum phosphate in patients with end-stage renal disease.

The Committee did not reach consensus on which additional studies may be required, and UK drug major Shire will work closely with the agency to agree upon the pathway forward. The FDA Advisory Committee's recommendation is not binding on the FDA, and no time has been set by to follow this recommendation, the firm noted.

As the Committee heard, "CKD patients are at an increased risk of death. In fact, a 30-year-old dialysis patient has the same risk of death as that of a 90-year-old with normal kidney function," said Keith Hruska, director of the pediatric nephrology division, Washington University School of Medicine. "These patients that progress to dialysis represent the 'survivors.' That's why it's important to help kidney patients stay as healthy as possible from the early stages of their disease." As a result of ongoing dialog with the FDA, Shire had requested that an Advisory Committee Meeting be convened to provide guidance on the studies needed to expand the use of phosphate binders. Following these discussions, the FDA formally invited all three sponsors - Shire, Fresenius and Genzyme - who presented at the October 16 meeting to collaborate on proving their case for treating hyperphosphatemia in CKD Stages 4 and 5 patients with phosphate binders.