“We are pleased that this medicine was approved for broad use, in both the pre-dialysis and dialysis settings, to control hyperphosphatemia in adults with chronic kidney disease,” said
“The differentiated profile of ferric citrate will be a new treatment option for our patients on dialysis and pre-dialysis,” said Gilbert Deray, MD, Professor of Nephrology at Université
“EC approval is another validation by a global regulatory agency of the medicine’s profile, and is another milestone in our efforts to expand the reach of ferric citrate to treat patients with renal disease,” said
The most commonly reported adverse reactions in dialysis-dependent CKD patients during treatment were discolored feces (18%) and diarrhea (13%). All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhea, gastritis, gastritis erosive, and hematemesis). The most commonly reported adverse reactions in CKD non-dialysis patients during treatment were discolored feces (27%) constipation (13%) and diarrhea (11%).
Ferric citrate coordination complex was approved under the brand name Auryxia™ by the
ABOUT HYPERPHOSPHATEMIA IN CHRONIC KIDNEY DISEASE
In the five major markets in
Managing patients on dialysis is complex as many metabolic factors, such as iron and phosphorus, are out of balance. Phosphate retention and resulting hyperphosphatemia in dialysis patients are typically associated with increased risk for heart and bone disease, and death. The majority of dialysis patients require chronic treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. In addition, iron can be severely depleted in dialyzed patients, who are often treated with intravenous iron and/or anemia medications, such as erythropoiesis stimulating agents (ESAs), to help boost red blood cell production.
The Summary of Product Characteristics for Fexeric will be available at www.keryx.com through
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA™ (ferric citrate)
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia™ (ferric citrate).
Iron Overload: Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.
Adverse Events: The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.
For Full Prescribing Information for Auryxia, please visit http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
Some of the statements included in this press release, particularly those regarding the approval and subsequent commercialization of Fexeric, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: whether we will able to identify and negotiate acceptable terms with a commercialization partner in the EU; whether we or a partner can successfully launch Fexeric in the EU; and other risk factors identified from time to time in our reports filed with the
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