Keryx Biopharmaceuticals announced that the Food and Drug Administration (FDA) has approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
The approval was based on data from a Phase 3 registration program. Ferric Citrate demonstrated its efficacy in reducing serum phosphorus levels to well within KDOQI guidelines range of 3.5–5.5mg/dL. Also, patients showed an increased ferritin and transferrin saturation (TSAT), where these parameters would have remained relatively constant in patients treated with active controls: Renvela (sevelamer carbonate; Genzyme) and/or Phoslo (calcium acetate; Fresenius).
Ferric Citrate is also being developed as a treatment for iron deficiency anemia in patients with Stage 3– 5 non-dialysis dependent CKD.
Ferric Citrate will be available as 210mg ferric iron tablets (equivalent to 1g ferric citrate) in 200-count bottles. The Company anticipates an approved brand name on or prior to launch.
For more information call (212) 531-5965 or visit Keryx.com.