FDA Approves Keryx’s Kidney Disease Drug Ferric Citrate
Keryx Biopharmaceuticals said it will launch its renal disease drug ferric citrate within 12 weeks, following FDA’s recent approval of the product that controls phosphorus levels in dialyzed chronic kidney disease (CKD) patients.
The approval was based on phase III trials that showed the drug reduced patients’ serum phosphorus levels to well within recommended levels, while boosting iron levels in the blood. This second factor is especially important as kidney dialysis often leads patients to develop anemia, which commonly is treated with iron infusions.
By contrast, patients taking either placebo or Sanofi’s Renvela (sevelamer carbonate) or Cardinal Health’s PhosLo (calcium acetate), the current standards of care, had iron and phosphorus levels that remained fairly constant.
The use of ferric citrate may allow some patients to reduce their iron dosages or discontinue IV iron therapy altogether, said lead investigator Julia Lewis of Vanderbilt University Medical Center.
The drug works by binding to phosphate ingested via food, blocking its absorption. It was approved in Japan in January for patients in all stages of CKD. A marketing authorization application is still under review in Europe for CKD patients on and off dialysis. The company is also working on developing it further in the U.S. for iron deficiencies in CKD patients in stages 3 to 5 who are not on dialysis.
The company estimates that more than 400,000 people in the U.S. require dialysis.
Ferric citrate, the drug’s generic name, previously had the brand name Zerenex. The FDA recently rescinded its approval of that name. Keryx said it will have a new brand name by launch time. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.