Shire has received approval through the European Mutual Recognition Procedure for an extension to the current indication for Fosrenol (lanthanum carbonate).
Reportedly, the extension is to make the non-calcium, non-resin phosphate binder available throughout the EU, to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis with a serum phosphorus level greather than or equal to 1.78mmol/l (5.5mg/dl).
In relation to the US, Shire continues to evaluate its options for securing a label extension to include CKD patients not on dialysis.
The company said that the extension was sanctioned by the Swedish Medicines Products Agency as reference member state. Submissions for national marketing authorisations have been made to Sweden and the other 28 European markets with first national approvals anticipated in Q4 2009.
Alastair Hutchison, Manchester Royal Infirmary in UK, said: “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. 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.”
Gian Piero Reverberi, senior vice president for international specialty pharmaceuticals at Shire, said: “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. 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.”