European regulators have cleared Keryx’ BioPharmaceuticals’ Fexeric to help control serum phosphorus levels in adults with chronic kidney disease.
The decision makes Fexeric (ferric citrate coordination complex) the first and only absorbable, iron-based phosphate binder to treat hyperphosphataemia in both non-dialysis and dialysis CKD patients in Europe.
Approval came after evidence from around 1,900 patients showed that Fexeric effectively reduced serum phosphorus levels to within the target range of 3.5 mg/dL to 5.5 mg/dL.
Regarding tolerability, the most commonly reported adverse reactions in dialysis-dependent CKD patients during treatment were discoloured faeces (18%) and diarrhoea (13%), while those in non-dialysis patients were discoloured faeces (27%) constipation (13%) and diarrhoea (11%).
In the five major markets in Europe, around 1.3 million people are diagnosed and treated with stages 3-5 CKD, with around 750,000 of these people estimated to have hyperphosphataemia.
The drug bagged US approval in September last year under the brand name Auryxia, but only for patients on dialysis.