Ferric Citrate approved by FDA for Hyperphosphatemia-Keryx Biopharma

Keryx Biopharmaceuticals has announced that the FDA has approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels for Dialysis Patients With Hyperphosphatemia. Approval of Ferric Citrate was based on data from its Phase III registration program in which Ferric Citrate effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL. In addition to the effects on serum phosphorus levels, Ferric Citrate's pharmacodynamic properties resulted in increased ferritin and transferrin saturation (TSAT); whereas these parameters remained relatively constant in patients treated with active control (Renvela and/or Phoslo).

The most common adverse events for Ferric Citrate treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation. Recently, the Company was informed by the FDA that approval of the brand name Zerenex had been rescinded. Keryx believes the Company will have an approved brand name on or prior to launch, although a brand name is not a pre-requisite for the launch of an FDA-approved drug.