FDA accepts application for Keryx Pharmaceutical's Auryxia

The U.S. Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for Auryxia (ferric citrate) tablets from Keryx Biopharmaceuticals Inc., a company specializing in innovative medicines to fight renal disease.
The sNDA would expand the drug’s current indication; as it stands, Auryxia is FDA approved for the control of serum phosphorus levels in patients with end-stage renal disease requiring dialysis. Keryx is seeking approval to allow the drug to be used for the treatment of iron deficiency anemia (IDA) in patients with non-dialysis dependent chronic kidney disease (NDD-CKD).
“Iron deficiency anemia is a common complication in people with non-dialysis dependent chronic kidney disease, yet currently there are no FDA-approved oral medicines to treat this debilitating disease,” Dr. John Neylan, senior vice president and chief medical officer of Keryx Biopharmaceuticals, said in a statement. “Acceptance of the sNDA filing not only brings us one step closer to providing this medicine to patients in need; it is an important milestone for the company and our efforts to leverage ferric citrate’s mechanism of action.”