Keryx Biopharmaceuticals, Inc. 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.

For more details, go to: http://investors.keryx.com/phoenix.zhtml?c=122201&p=irol-newsArticle&id=2070854