Anemia Indication Sought for Phosphate Binder
Company asks FDA to approve ferric citrate for iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease.
The FDA has accepted for review a supplemental New Drug Application (sNDA) for ferric citrate (Auryxia) that seeks to expand the indication for the drug to include treatment of iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease (NDD-CKD). Ferric citrate, which is made by Boston-based Keryx Biopharmaceuticals, is currently approved for control of serum phosphorus in patients with end-stage renal disease.
“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,” John Neylan, MD, Keryx's senior vice president and chief medical officer, said in a company press release.
The sNDA was based on data from a 24-week placebo-controlled phase 3 trial involving 234 adults with stage 3 to 5 NDD-CKD. Ferric citrate was associated with significant increases in hemoglobin levels of 1 g/dL or greater at any point during the 16-week efficacy period in 52% of patients, according to Keryx.