FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease Patients
At the U.S. food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee meeting, 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.
As a result of ongoing dialogue 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 who presented at today's meeting to collaborate on demonstrating their case for treating CKD Stage 4 and 5 patients who have hyperphosphatemia with phosphate binders.
Other news from the department research and development
