Keryx NDA Accepted for CKD Treatment

Keryx Biopharmaceuticals‘ NDA for Zerenex (ferric citrate coordination complex) has been accepted for filing by the FDA. The acceptance indicates that the FDA has determined that the application is sufficiently complete to permit a substantive review.

The company’s NDA, submitted on August 7, 2013, seeks approval for the marketing and sale of Zerenex as a treatment for elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis. Included in the NDA filing are safety and efficacy datasets derived from Keryx’ Phase III program, which was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA, as well as safety and efficacy data from several additional studies, including four Phase III studies conducted in Japan in CKD patients on dialysis.

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii). On January 7, 2013, JT announced the filing of its NDA with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with CKD.

Zerenex is also in Phase II development in the U.S. for the management of elevated phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent CKD.