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FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease Patients With Hyperphosphatemia
Date:10/16/2007

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.

"Shire is committed to offering its effective phosphate binder, FOSRENOL, to kidney patients who need protection from the complications of elevated serum phosphorus," said Joseph Schlitz, vice president, U.S. Renal Business, Shire Pharmaceuticals. "The high affinity of FOSRENOL for phosphate provides effective monotherapy in a simple dosing regimen, which is one tablet per meal for most patients. Along with its well-established safety profile, FOSRENOL offers an attractive solution for both patients and their healthcare providers. Shire is therefore confident that FOSRENOL is well suited to be a first-line, non-calcium treatment of choice for CKD Stage 4 patients."

While the normal adult range for serum phosphorus is 2.5 to 4.5 milligrams per deciliter (mg/dL), the serum phosphorus levels of many patients on dialysis often exceed 6.5 mg/dL. The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines recommend that monitoring for hyperphosphatemia should begin in patients with CKD Stage 3, and that serum phosphorus should be maintained within the target range of 2.7 to 4.6 mg/dL in patients with CKD Stages 3 and 4, or 3.5 to 5.5 mg/dL for CKD Stage 5.

"Based on data in dialysis patients, it is reasonable to expect that treating pre-dialysis patients for secondary conditions, such as hyperphosphatemia, may slow the progression of their bone and cardiovascular disease," said Hartmut H. Malluche, M.D., chief, Nephrology, Bone and Mineral Metabolism, Department of Internal Medicine, University of Kentucky College of Medicine. "Studies have shown that FOSRENOL also is associated with a trend
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SOURCE Shire plc
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