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 us closer to the ideal phosphate binder, since it can be integrated easily into patients' day-to-day schedules and has shown reliable efficacy and safety in a number of well designed clinical trials".

In clinical trials, patients treated with FOSRENOL achieved rapid, significant reductions in serum phosphorus within one week of starting therapy 7, and reached target levels within eight weeks.8 FOSRENOL has also demonstrated long-term efficacy and safety, with some patients maintaining reduced phosphate levels for 36 months or more.9 Additionally, bone biopsies taken from patients who had been treated with FOSRENOL for up to four years showed that patients maintained healthy bone throughout the duration of treatment.10

Matthew Emmens, Chief Executive of Shire commented: "The approval of FOSRENOL in the U.S. is another milestone for Shire. FOSRENOL provides a much-needed treatment for end-stage renal disease patients, since less than a third are able to control phosphate levels with existing medications. Without effective treatment, patients can suffer serious health complications such as bone disorders and life-threatening heart and circulation problems. Final launch preparations begin immediately and we anticipate that U.S. physicians will be able to prescribe FOSRENOL to their patients from the end of the year."

Source: Eurekalert & others

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