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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

PHILADELPHIA, Oct. 16 /PRNewswire/ -- 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.

CKD is divided into five stages based on the level of kidney function, with higher stages of disease representing lower kidney filtration rates. In the United States, approximately 20 million adults have some form of CKD, of whom 500,000 have developed ESRD (or CKD Stage 5). An additional 400,000 individuals have significant loss of kidney function and are classified as having CKD Stage 4. Worldwide, almost 1.5 million people with CKD are on dialysis.

"As the Committee heard today, 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, M.D., Professor of Pediatrics, Medicine and Cell Biology, Director, Division of Pediatric Nephrology, 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 dialogue with the FDA, Shire had requested that an Advisory Committee Meeting
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SOURCE Shire plc
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