8. March 2012 12:51
Shire’s oral powder formulation of Fosrenol (lanthanum carbonate) has received approval through the European Decentralised Procedure.
The convenient formulation is used to control hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis.
It is also indicated for use in adult patients with chronic kidney disease not on dialysis in whom a low phosphate diet alone is insufficient to control serum phosphate levels.
Angus Hogg, Product General Manager at Shire, says the new formulation has been developed “so that patients have an additional choice and that patients who may find it easier to take their treatment in powder form are able to do so”.
The approval of Fosrenol was granted by the Swedish Medical Product Agency, who acted as a reference member state.
Clinical studies involving more than 6,000 subjects demonstrated the efficacy and safety of Fosrenol. It was first approved in Sweden in March 2004, and by the FDA in October 2004. It was subsequently approved in 28 EU markets and is now available in a total of 41 markets globally.
“Shire is delighted to receive European approval for the oral powder formulation of Fosrenol,” said Angus Hogg. “We believe the new oral powder formulation of Fosrenol demonstrates our commitment to enabling people with life-altering conditions to lead better lives.”