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FDA approves Fosrenol(R) in end-stage renal disease (ESRD) patients

Basingstoke, UK, 27 October 2004 The U.S. Food and Drug Administration (FDA) today approved FOSRENOL (lanthanum carbonate), a new non-calcium, non-aluminium phosphate binder that reduces high serum phosphate levels in patients with end-stage renal disease (ESRD).

Even with a low phosphorus diet, most people undergoing kidney dialysis develop hyperphosphataemia (high phosphorus levels in the blood).1,2 Without effective treatment, this condition often leads to renal osteodystrophy, a collection of bone diseases that causes bone pain, brittle bones, skeletal deformities and fractures.3 Accumulating evidence also shows that hyperphosphataemia contributes to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients.4,5,6

The FDA approval is welcomed by US nephrologists. "Maintaining ESRD patients' serum phosphorus levels within a normal range has been very challenging because phosphorus is continually being absorbed into the body from food, and dialysis does not completely eliminate it from patients' blood," said William F. Finn, M.D., professor of medicine at the University of North Carolina School of Medicine at Chapel Hill. "FOSRENOL has been shown to be effective and well- tolerated in clinical studies, and is likely to aid in simplifying the management of hyperphosphatemia for patients and physicians."

The U.S. approval follows Swedish regulatory approval for FOSRENOL granted in March this year. Shire is pursuing further European approvals for this product via the Mutual Recognition Process.

"Effective reduction of phosphate levels in patients with kidney disease could make a real impact on their lives" said Dr Alastair Hutchison, Manchester Institute of Nephrology & Transplantation, UK. "In my opinion, existing therapies have numerous shortcomings from long-term safety issues to high pill burdens and poor intestinal tolerability. I believe FOSRENOL moves
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Contact: Elizabeth Park
elizabeth.park@resolutecommunications.com
44-207-357-8187
Resolute Communications
27-Oct-2004


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