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news.The US Food and Drug Administration (FDA) has approved the trade name Auryxia (ferric citrate) for Keryx Biopharmaceuticals' FDA-approved ferric citrate.
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Keryx is a biopharmaceutical firm focused on bringing new therapies to market for patients with renal disease.
In September 2014, Auryxia was approved by the FDA to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
Keryx chief executive officer Ron Bentsur said: "We are excited to receive FDA approval of the trade name Auryxia.
"We look forward to launching Auryxia in the U.S. at year end and to providing nephrologists with an effective phosphate binder for dialysis-dependent CKD patients."
The US approval of Auryxia was based on data from the company’s Phase III clinical trials, in which the drug reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 to 5.5mg/dL.
The ferric iron component in Auryxia binds with dietary phosphate in the GI tract, and precipitates as ferric phosphate.
The unbound ferric iron in Auryxia has increased serum iron parameters including ferritin and transferrin saturation (TSAT) and these parameters remained relatively constant in patients treated with active control (Renvela and/or Phoslo).