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news.The European Medicines Agency (EMA) has validated Keryx Biopharmaceuticals' marketing authorization application (MAA) which seeks the approval of Zerenex (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease (CKD), including dialysis- and non-dialysis-dependent CKD.
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The MAA validation confirms that the submission is sufficiently complete to start the formal review process.
The EMA’s review of the MAA will follow the centralized marketing authorization procedure.
If approved, Zerenex will receive marketing authorization in all 27 member states of the EU, as well as in Norway, Liechtenstein and Iceland.
Keryx chief executive officer Ron Bentsur said, "We are grateful for the EMA’s quick validation of our MAA submission and look forward to working with the EMA during the MAA review process."
The company also has a new drug application (NDA) for Zerenex under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of 07 June 2014 seeking the approval of Zerenex for the treatment of hyperphosphatemia in patients with CKD on dialysis.
Keryx retains a worldwide exclusive license to Zerenex from Panion & BF Biotech.