This article is more than 5 years old. Information may no longer be current.
FDA expands Auryxia indication to treat iron deficiency anemia in chronic kidney disease
Click Here to Manage Email Alerts
The FDA expanded the indication for ferric citrate tablets to include the treatment of iron deficiency anemia among adult patients with chronic kidney disease who are not on dialysis.
The agency’s decision included data from a 24-week placebo-controlled phase 3 trial, designed to evaluate ferric citrate (Auryxia, Keryx Biopharmaceuticals) in 234 adults with stage III to V non-dialysis dependent chronic kidney disease.
Patients treated with ferric citrate demonstrated significant increases in hemoglobin levels of more than 1 g/dL at any point during the 16-week efficacy period (52.1% vs. 19.1%) compared with the placebo arm.
The agent appeared well-tolerated, and was consistent with its known safety profile.
The most common adverse events included diarrhea (21%), constipation (19%), discolored feces (15%), nausea (11%), abdominal pain (6%) and hyperkalemia (7%).
“We are pleased with the broad indication permitted by the FDA, as a first-line treatment option for adults with iron deficiency anemia and chronic kidney disease, not on dialysis,” John Neylan, MD, senior vice president and chief medical officer of Keryx Biopharmaceuticals, said in a company-issued release. “Physicians and their patients now have a new treatment option to help manage a serious complication of this complex disease.”
Ferric citrate is indicated for the control of serum phosphorus levels among patients with chronic kidney disease who require dialysis.