Keryx Biopharmaceuticals Inc. said ferric citrate met the goals of a Phase 3 study to treat iron deficiency anemia in adults with stage 3-5 non-dialysis dependent chronic kidney disease.
The study compared treatment with ferric citrate to placebo in 234 patients who previously had not adequately responded to or tolerated current oral iron therapies. The study achieved the primary endpoint with 52% (61/117) of patients who received ferric citrate achieving a 1g/dL or greater rise in hemoglobin at any time point during the 16-week randomized efficacy period, compared to 19% (22/115) in the placebo group (p<0.001).
The drug was approved under the brand name Auryxia to control serum phosphorus levels in patients with CKD on dialysis in September 2014 and launched in December 2014. The company said it would apply with U.S Food and Drug Administration an expanded approval.