Shire’s phosphate binder Fosrenol (lanthanum carbonate) has gained approval in the EU for an extension of indication through the European Mutual Recognition Procedure.
This approval paves the way for Fosrenol’s use to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis, with a serum phosphorus level greater than or equal to 1.78mmol/L (5.5mg/dL).
The extension was sanctioned by the Swedish Medicines Products Agency as reference member state.
“Failure to control phosphate in the earlier stages of chronic kidney disease carries well-documented risks, and is associated with reduced bone health and poor cardiovascular outcomes,” said Dr Alastair Hutchison, Manchester Royal Infirmary.
“The extension to the existing indication for Fosrenol provides nephrologists in the EU with an important additional option to help tackle the challenge of uncontrolled phosphate at an earlier stage in the progression of kidney disease, before the need for dialysis treatment.”
“This is an important development in helping CKD patients better manage their elevated phosphate and we are pleased that Fosrenol is now approved as a treatment option for these patients in the EU,” added Gian Piero Reverberi, Senior Vice President, International Specialty Pharmaceuticals, Shire. “We are firmly committed to serving the needs of renal patients and ensuring that Fosrenol is available to the prescribers and patients who can benefit from it.”