Shire Pharmaceuticals Group plc has received approval from the US FDA for Fosrenol (lanthanum carbonate), a new phosphate binder that reduces elevated blood levels of phosphate in patients with End-Stage Renal Disease (ESRD).

The US 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, the company said in a release.

Matthew Emmens, chief executive of Shire commented: "The approval of Fosrenol in the US 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 phosphorus 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 Fosrenol will be available in pharmacies before the end of 2004."

Says William F. Finn, professor of medicine at the University of North Carolina School of Medicine at Chapel Hill: "Maintaining ESRD patients' serum phosphate 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. Fosrenol has been shown to be effective and well-tolerated in clinical studies in reducing phosphate levels and is likely to aid in simplifying the management of hyperphosphatemia for patients and physicians."

There are currently over one million dialysis patients worldwide and the number is estimated to be increasing by approximately 8 per cent per year. Up to 80 per cent of patients have high phosphate levels. If left untreated, high phosphate levels can lead to diseases of the heart and blood vessels; these may be fatal.

In extensive clinical trials, Fosrenol has been well tolerated and has been used in patients for long-term treatment. Shire has developed this new chemical entity from very early stages all the way through to launch and that patients and physicians will now be able to benefit from an important new choice of treatment, the release said.