FDA Approves New Indication for Auryxia
Officials with the FDA have expanded the approval of ferric citrate (Auryxia, Keryx Biopharmaceuticals) tablets to include the treatment of adults with iron deficiency anemia and chronic kidney disease, not on dialysis. The additional indication makes ferric citrate the only oral treatment option available for these patients.
Ferric citrate was originally approved in September 2014 for the control of serum phosphorus levels in patients with chronic kidney disease who require dialysis.
The expanded approval is based on data from a phase 3 clinical trial. In the study, 234 adults with stage 3-5 non-dialysis dependent chronic kidney disease were enrolled. 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. The participants took 3 tablets per day, with meals, as the starting dose. During the study, patients were not allowed to receive any intravenous or oral iron, or erythropoiesis-stimulating agents. Treatment with ferric citrate demonstrated a significant increase in hemoglobin levels during a 16-week efficacy period in most of the patients.
The most common reported adverse events in the phase 3 study were diarrhea, constipation, discolored feces, nausea, abdominal pain, and hyperkalemia.
US FDA approves Auryxia (ferric citrate) tablets as a treatment for people with iron deficiency anemia and chronic kidney disease, not on dialysis [news release]. Boston. Keryx Biopharmaceuticals’ website. http://investors.keryx.com/phoenix.zhtml?c=122201&p=irol-newsArticle&ID=2314886. Accessed November 7, 2017.