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.