Keryx announces publication of Auryxia Phase 3 results
Keryx Biopharmaceuticals announced the publication of results from its pivotal Phase 3 study evaluating ferric citrate for iron deficiency anemia in non-dialysis-dependent chronic kidney disease in the online issue of the Journal of the American Society of Nephrology. Ferric citrate (Auryxia) is currently indicated in the U.S. as a phosphate binder for the control of serum phosphorus levels in patients with CKD on dialysis. Data in the publication highlight an investigational use of ferric citrate as a potential oral treatment for adults with IDA and NDD-CKD. The article titled, "Effects of Ferric Citrate in Patients with Non-Dialysis-Dependent CKD and Iron Deficiency Anemia," describes previously reported Phase 3 results, in which ferric citrate achieved statistically significant results on the primary and all five pre-specified secondary endpoints for the treatment of IDA in adults with NDD-CKD versus placebo. Patients enrolled in the trial had not adequately responded to or could not tolerate prior treatment with oral iron. In the Phase 3 study, ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile, with diarrhea reported as the most common adverse event. "The results shown in this pivotal study demonstrated that ferric citrate, if approved for this indication, could provide an important new treatment option for people living with chronic kidney disease and iron deficiency anemia who are not on dialysis," said Steven Fishbane, M.D., chief of nephrology for North Shore University Hospital and Long Island Jewish Medical Center. "Not only did ferric citrate deliver a clinically meaningful 1 g/dL increase in hemoglobin levels for the majority (52.1 percent (61/117)) of patients treated in the Phase 3 study at any point during the 16-week efficacy period, increases were seen as early as one to two weeks after start of treatment, and were sustained for the majority of patients who achieved the primary endpoint." "Clinical trials are critical to the advancement of safe and effective medicines, and we thank the patients, their families and the renal care teams who have participated in clinical trials for ferric citrate," said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. "We are pleased to have these data highlighted by a major nephrology journal, which can provide broad access for nephrologists to the Phase 3 results. We recently submitted a supplemental new drug application with these data to the U.S. FDA. If approved for this expanded indication, ferric citrate would be the first oral medicine approved by the FDA for the treatment of iron deficiency anemia in patients with NDD-CKD."