The FDA has approved the phosphate binder ferric citrate (Auryxia) for an additional indication: iron-deficiency anemia in non-dialysis-dependent chronic kidney disease (CKD) patients.
“Physicians and their patients now have a new treatment option to help manage a serious complication of this complex disease,” John Neylan, MD, senior vice president and chief medical officer of Keryx Biopharmaceuticals, Inc., the makers of Auryxia, said in a news release.
The approval followed positive results from a 24-week phase 3 trial comparing ferric citrate with placebo in 234 adults with stage 3-5 CKD not on dialysis who had low hemoglobin (Hb) levels (9.0-11.5 g/dL) and inadequate response to oral iron supplements. Patients started with 3 tablets daily with meals and increased to an average 5 tablets per day. No one received intravenous, oral iron, or erythropoiesis-stimulating agents.
For 52.1% of patients taking ferric citrate, Hb significantly increased 1 g/dL or more at some point during the 16-week efficacy period compared with only 19.1% of placebo recipients, according to results published online January 2017 in the Journal of the American Society of Nephrology.
Adverse events were in line with its published known safety profile. The most frequent adverse events were gastrointestinal: diarrhea (21%), constipation (19%), discolored feces (15%), nausea (11%), abdominal pain (6%) and hyperkalemia (7%).
US FDA approves Auryxia (ferric citrate) tablets as a treatment for people with iron deficiency anemia and chronic kidney disease, not on dialysis. Keryx Pharmaceuticals; November 6, 2017 [new release].