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BOSTON, July 24, 2015 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of ferric citrate coordination complex (EU approved brand name Fexeric®) recommending approval for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD). Fexeric was approved under the brand name Auryxia™ by the U.S. Food and Drug Administration in September 2014, and is indicated in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
"We are pleased to receive this positive opinion from the CHMP for Fexeric, as it is an important step in providing a new treatment option in phosphorus management for adult patients with CKD in both the non-dialysis and dialysis settings," said John Neylan, M.D., chief medical officer of Keryx. "We look forward to the European Commission's decision in the coming months."
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the European Union (EU) and Iceland, Norway and Liechtenstein. The EC generally follows the recommendation of the CHMP and typically issues its final opinion approximately two to three months following CHMP opinion. Keryx expects to make a decision about its EU commercial strategy by the end of 2015.
DATA SUPPORTING POSITIVE OPINION
The CHMP opinion is based on evidence from approximately 1900 patients, including two key clinical trials: a Phase 2, non-dialysis study and a 58-week, Phase 3 registration trial. In the Phase 3 trial, ferric citrate effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL. These data were published in 2014 in the Journal of the American Society of Nephrology.
The most commonly reported adverse events 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%). A summary of the CHMP opinion can be accessed at ema.europa.eu.
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.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate)
In the European Union, ferric citrate coordination complex is an investigational medicine and its safety, efficacy and product labeling have not been established. Keryx markets ferric citrate in the U.S. under the trade name Auryxia™.
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.
For Full Prescribing Information for Auryxia in the U.S., please visit http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals, with offices in New York and Boston, is focused on bringing innovative therapies to market for patients with renal disease. In December 2014, the Company launched its first FDA-approved product, Auryxia (ferric citrate) for the treatment of elevated serum phosphorus levels in patients with chronic kidney disease on dialysis, in the United States. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. For more information about Keryx, please visit www.keryx.com.
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 the European Commission will concur with the recommendation of the CHMP and grant approval of Fexeric; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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