The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending approval of Keryx Biopharmaceuticals Inc.’s ferric citrate to treat hyperphosphatemia in adults with chronic kidney disease not dependent on dialysis.
Ferric citrate is currently marketed in Europe under the brand name Fexeric to treat hyperphosphatemia in adults with chronic kidney disease dependent on dialysis, and in the United States under the brand name Auryxia.
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 and Iceland, Norway and Liechtenstein.
“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, MD, chief medical officer of Keryx.
Keryx is seeking to expand the indication for Auryxia to include the treatment of iron deficiency anemia in patients with stages 3 – 5 non-dialysis dependent chronic kidney disease, who have previously not responded to oral iron therapy. Keryx initiated a phase 3 study for this indication in September 2014 and this study is now more than 70% enrolled. This placebo-controlled study is expected to enroll 230 patients and will evaluate changes in hemoglobin as the primary endpoint. Keryx said it is on track to complete the study by the end of 2015. If this study is successful, Keryx intends to file a supplemental new drug application with the FDA seeking label expansion of Auryxia.