The U.S. Food and Drug Administration has accepted for review the supplemental New Drug Application for Keryx Biopharmaceuticals Inc.’s Auryxia (ferric citrate) tablets. The Prescription Drug User Fee Act target action date for completion of the FDA’s review is Nov. 6, 2017.
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. Keryx, with this sNDA submission, is seeking to expand the indication for Auryxia to include 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,” said John Neylan, MD, senior vice president and chief medical officer of Keryx Biopharmaceuticals. “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.”
The sNDA was based on data from a 24-week placebo controlled Phase 3 trial in 234 adults with stage 3-5 NDD-CKD. Patients enrolled in the trial had hemoglobin levels between 9.0 g/dL and 11.5 g/dL and were intolerant to or had an inadequate response to prior treatment with oral iron supplements.
The starting dose in the study was three tablets per day taken with meals. During the study, patients were not allowed to receive any IV or oral iron, or ESAs.
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. In the trial, 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.