Zerenex ferric citrate regulatory update

Keryx submitted an MAA to EMA for Zerenex ferric citrate to treat hyperphosphatemia in dialysis-dependent and non-dialysis-dependent patients with chronic kidney disease (CKD). The product is under FDA review for CKD in dialysis patients, with a June 7 PDUFA date. In January, Japan approved the oral ferric iron-based phosphate binder as Riona (see BioCentury, Jan. 20). ...