In studies, FOSRENOL has been shown to be an effective and well tolerated phosphate binder, lowering serum phosphate levels within eight weeks and maintaining this long-term, with some patients treated for 36 months (three years) or more.5,6 A recently-published 12-month study in new dialysis patients showed that treatment with FOSRENOL led towards normalization of pre-existing bone disease, compared to patients treated with calcium carbonate, a commonly used phosphate binding medicine.7

Dr Wilson Totten, Chief Scientific Officer of Shire, said: "This first approval for FOSRENOL represents an important milestone for Shire. For clinicians and patients alike, we believe FOSRENOL represents a significant milestone, as a real, effective and well-tolerated alternative to current therapies."

Shire recently confirmed its out-licensing of the rights to develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd. Shire has acquired the rights to the global patents for FOSRENOL, excluding Japan, from AnorMED Inc.