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FDA Expands Auryxia Indication to CKD Patients Not on Dialysis

Megan Brooks

November 07, 2017

The US Food and Drug Administration (FDA) has expanded the use of ferric citrate tablets (Auryxia, Keryx Biopharmaceuticals) to
patients with iron deficiency anemia and chronic kidney disease (CKD) who are not on dialysis.

The FDA approved ferric citrate in September 2014 for the control of serum phosphorus levels in patients with CKD who are undergoing
dialysis, as reported by Medscape Medical News.

"More than half of the approximate 30 million people in the United States living with chronic kidney disease are iron deficient, and yet, this
is the only tablet that has been developed and approved specifically to address iron deficiency anemia in these patients, who are not on
dialysis," Steven Fishbane, MD, chief of the Division of Kidney Diseases and Hypertension at Northwell Health in Great Neck, New York,
said in a company news release.

Approval of the supplemental new drug application for ferric citrate was based on results from a 24-week placebo-controlled phase 3
clinical trial in 234 adults with stage 3 to 5 non–dialysis-dependent CKD.

Patients enrolled in the trial had hemoglobin levels between 9.0 and 11.5 g/dL and had not responded to or were intolerant to prior
treatment with oral iron supplements. The starting dose in the study was three tablets daily taken with meals; the mean dose was five
tablets daily. None of the patients received intravenous or oral iron or erythropoiesis-stimulating agents during the study period.

For most patients, treatment with ferric citrate (vs placebo) was associated with significant and "clinically meaningful" increases in
hemoglobin levels of greater than 1 g/dL at any point during the 16-week efficacy period (52% vs 19%), the company notes.

Ferric citrate was generally well tolerated, and adverse events were consistent with its known safety profile. The most common adverse
events were diarrhea (21%), constipation (19%), discolored feces (15%), nausea (11%), abdominal pain (6%), and hyperkalemia (7%).

The results of the study were published earlier this year in the Journal of the American Society of Nephrology.

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Cite this article: FDA Expands Auryxia Indication to CKD Patients Not on Dialysis - Medscape - Nov 07, 2017.

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