Keryx Biopharmaceuticals sNDA for Auryxia Accepted

FDA has accepted a Keryx Biopharmaceuticals supplemental NDA for Auryxia (ferric citrate) tablets, which seeks an expanded indication to include the treatment of iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease (NDD-CKD). Auryxia is currently approved for use in the U.S. for the control of serum phosphorus levels in patients with end-stage renal disease requiring dialysis. The agency has set a user fee review target date of 11/6.

The submission is supported by data from a 24-week, placebo-controlled Phase 3 trial in 234 adults with stage 3-5 NDD-CKD. “In the study, treatment with Auryxia demonstrated significant increases in hemoglobin levels of >1 g/dL at any point during the 16-week efficacy period for the majority of patients (52.1 percent; n=61/117), a clinically meaningful result,” the company says.