New York and Boston based Keryx Biopharmaceuticals, a company focused on bringing innovative therapies for patients with renal disease to market, has announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has formed a positive opinion with regard to granting marketing authorization for Keryx’s lead product, a ferric citrate coordination complex to be sold under the EU approved brand name Fexeric. The CHMP is recommending the drug’s approval for treatment of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD).
Fexeric, if final authorization is approved, will be available as film-coated tablets containing 210mg of ferric iron in 1g of ferric citrate coordination complex, and will be the only absorbable, iron-based phosphate binder product to treat elevated serum phosphorus levels in both non-dialysis and dialysis CKD patients available in Europe. The benefits with Fexeric are its ability to reduce serum phosphorus in patients with chronic kidney disease, as shown in a pivotal study where patients treated with Fexeric had a significant decrease in serum phosphorus compared with patients treated with placebo. The drug’s most common side effects are gastrointestinal disorders.
The U.S. Food and Drug Administration (FDA) approved the same proprietary oral, ferric iron-based phosphate binder formula for control of serum phosphorous levels in patients with chronic kidney disease (CKD) on dialysis, sold under the brand name Auryxia in the United States, on September 5, 2014,.
Auryxia, Keryx’s first FDA-approved product, was launched in the United States in December 2014. In January 2014, ferric citrate had been approved for treatment of patients with all stages of CKD in Japan, where it is marketed as Riona by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
“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,” says John Neylan, M.D., chief medical officer of Keryx. “We look forward to the European Commission’s decision in the coming months.”
“I am honored to be joining an organization so clearly dedicated to improving the lives of those with kidney disorders,” Dr. Neylan continues. “I look forward to working with my new colleagues as well as the many experts around the world who are helping to bring to patients in need.”
Dr. Neylan, an accomplished nephrologist, transplantation specialist, and biopharmaceutical executive with broad-based experience in therapeutic development, from the preclinical phase to post-marketing development of therapies across primary care, specialty and rare disease indications, came to Keryx last April from Genzyme Corporation, where since 2008 he had served in the capacity of Senior Vice President, Clinical Development, focusing on specialty metabolic diseases.
The CHMP committee’s positive opinion now must be reviewed by the European Commission (EC), which is authorized to approve medicines for use in the 28 countries of the European Union (EU) plus Iceland, Norway and Liechtenstein. The EC generally follows the the CHMP’s recommendations, and typically issues its final opinion approximately two to three months following CHMP opinion. Keryx expects to begin making decisions about its EU commercial strategy by the end of 2015.
Data Supporting CHMP Positive Opinion
The CHMP opinion on Fexeric is based on evidence from approximately 1900 patients, including findings of two key clinical trials: a Phase 2, non-dialysis study and a 58-week, Phase 3 registration trial. In the Phase 3 trial, Keryx reports that ferric citrate effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL — data that were published in 2014 in the Journal of the American Society of Nephrology.
A summary of the CHMP opinion can be accessed at:
Keryx notes that managing patients on dialysis is complex, due to many metabolic factors, such as iron and phosphorus, being out of balance. Phosphate retention and the resulting condition hyperphosphatemia in dialysis patients are typically associated with increased heart and bone disease, risk for , and risk of 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.
For Full Prescribing Information for Auryxia in the U.S., visit:
Keryx Biopharmaceuticals, Inc.