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news.The US Food and Drug Administration (FDA) has granted approval for Keryx Biopharmaceuticals for ferric citrate (formerly Zerenex) to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
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The approval was based on data from a Phase III registration program, which showed that ferric citrate reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL.
Apart from the effects on serum phosphorus levels, ferric citrate’s pharmacodynamic properties resulted in increased ferritin and transferrin saturation (TSAT); while these parameters remained relatively constant in patients treated with active control (Renvela and/or Phoslo).
The most common adverse events observed in patients treated with ferric citrate were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation.
Keryx chief executive officer Ron Bentsur said the company is happy with the FDA’s decision to approve Ferric Citrate, and look forward to bringing it to market in the US within the next 12 weeks.
"We are committed to bringing innovative therapies to the market for patients with kidney disease and are excited to be offering this important treatment option to dialysis patients," Bentsur said.
Currently, Keryx is in the process of determining a new brand name for ferric citrate after the FDA recently informed the company that Zerenex had to be rescinded.