Approval for FOSRENOL (lanthanum carbonate), which controls phosphate levels in renal dialysis patients

Mar 25 2004

Sweden approves innovative treatment to reduce phosphate risk in patients with end stage renal failure; now FOSRENOL to enter EU mutual recognition procedure

Sweden's MPA has today granted the first regulatory approval in the world for FOSRENOL (lanthanum carbonate), a non-calcium, non-aluminium phosphate binding medicine developed to control phosphate levels in renal dialysis patients. Sweden will now become the Reference Member State in the EU Mutual Recognition Procedure for FOSRENOL, and this is the first step in securing marketing approval throughout Europe. A submission has also been made by Shire to gain marketing approval for FOSRENOL in the United States.

FOSRENOL is a treatment for high phosphate levels in the blood (hyperphosphataemia), which occurs in patients with end stage renal failure. Even with a low phosphate diet as many as 80% of dialysis patients develop hyperphosphataemia.1,2 Estimates show that there are 225,000 people undergoing dialysis in Europe, 290,000 people with end stage renal failure in the US, and 167,000 people in the Pacific Rim who need dialysis treatment. Without effective treatment, hyperphosphataemia can lead to renal osteodystrophy - a bone disease which causes pain, skeletal deformities, and can result in fractures. Recent research also suggests that hyperphosphataemia is associated with the development of cardiovascular disease, which accounts for nearly 50% of all deaths in dialysis patients 3,4.

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.