Keryx Biopharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its ferric citrate (formerly known as Zerenex), a new oral iron-based treatment for dialysis patients with hyperphosphatemia.
Ferric citrate will be used to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
Keryx Biopharmaceuticals CEO Ron Bentsur said: "We are thrilled 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."
The approval was based on firm’s data from the Phase III registration programme, in which ferric citrate effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5mg/dL to 5.5mg/dL.
Recently, FDA officially cancelled the brand name Zerenex, according to the company.
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In Japan, the company received approval for Ferric Citrate to treat patients with all stages of CKD in January, while its Japanese partner Japan Tobacco is selling the product under the name of Riona.
Keryx has tendered a marketing authorization application (MAA) to the European Medicines Agency (EMA) for ferric citrate to treat hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent patients. It is currently under review.
In the US, the company is also developing ferric citrate as a treatment for iron deficiency anemia in patients with stage III to V non-dialysis dependent chronic kidney disease (CKD).