The Food and Drug Administration (FDA) has approved Auryxia (ferric citrate; Keryx) for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD) who are not on dialysis.
The new approval was based on results from a 24-week placebo controlled Phase 3 trial involving 234 adults with stage 3-5 non-dialysis dependent chronic kidney disease. Patients 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. During the trial, they were not allowed to receive any intravenous (IV) or oral iron, or erythropoiesis-stimulating agents.
Results showed that 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% vs. 19.1% for placebo.
The most commonly reported adverse events in the Auryxia group were diarrhea (21%), constipation (18%), discolored feces (21%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%).
Auryxia is already approved for the control of serum phosphorus levels in patients with chronic kidney disease who require dialysis.
For more information visit Auryxia.com.