FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease

At the U.S. Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee meeting today, the majority of members voted to recommend the use of phosphate binders, including Shire Pharmaceuticals' non-calcium FOSRENOL(R) (lanthanum carbonate), to treat hyperphosphatemia (elevated levels of phosphorus in the blood) in chronic kidney disease (CKD) Stage 4 patients. Currently, FOSRENOL is indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).

The Committee did not reach consensus on which additional studies may be required, and Shire will work closely with the FDA 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 which the FDA will decide whether to follow this recommendation.