FDA Approves Keryx's Ferric Citrate For Hyperphosphatemia
By Cyndi Root
Keryx Biopharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has approved Ferric Citrate (previously Zerenex). The new, oral iron-based treatment is for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The approval was based in part on Phase III trials showing that Ferric Citrate reduced serum phosphorus levels to well within the KDOQI guidelines from the National Kidney Foundation to a range of 3.5 mg/dL to 5.5 mg/dL. The approval included stipulations and warnings, but the company plans to bring the product to market within 12 weeks.
Ferric Citrate
Ferric Citrate was formerly branded as Zerenex. However, because the FDA recently rejected this name, Keryx is working with the regulatory body to rename the drug in time for launch, even though a brand name is not a pre-requisite for marketing.
In Japan, the drug was approved for patients with all stages of CKD and is marketed as Riona by Japan Tobacco and Torii Pharmaceutical, Keryx’s partners. The drug is currently under review with the European Medicines Agency (EMA). Keryx is also studying the drug for iron deficiency anemia in patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease (CKD).
Ferric Citrate is a phosphate binder with unique pharmacodynamic properties that make it highly effective in controlling serum phosphorous levels. The drug may stimulate an increase in iron stores, meaning health providers must monitor iron levels and adjust the Ferric Citrate dose or discontinue IV iron therapy.
FDA Action
The FDA approval of Ferric Citrate is Keryx’s first approval. However, the FDA warnings limit the drug’s marketability. The patient population is restricted as the FDA says that the drug is not for patients with hemochromatosis (iron accumulation) and patients with gastrointestinal inflammation or bleeding.
About Keryx
Keryx has offices in New York City and Boston, an emerging hub for life sciences. The company currently has 90 employees, which it expects to expand to 150 to support sales of Ferric Citrate. The company partners with Japanese companies to market Ferric Citrate and is considering marketing partners in the EU upon regulatory approval.