Keryx Says FDA Accepts For Filing Of Zerenex New Drug Application

(RTTNews) - Keryx Biopharmaceuticals, Inc.(KERX), Tuesday said that its New Drug Application or NDA for Zerenex has been accepted for filing by the U.S. Food and Drug Administration or FDA. The acceptance for filing of the NDA means the determination by the FDA that the application is sufficiently complete to permit a substantive review, the company said.

The NDA was submitted on August 7, and it seeeks approval for the marketing and sale of Zerenex as a treatment for elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease or CKD on dialysis. The NDA includes safety and efficacy datasets derived from the Company's Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment agreement with the FDA, as well as safety and efficacy data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.

Zerenex is also in Phase 2 development in the U.S. 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, 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.