Tuesday, January 5, 2010

Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Registration Program of Zerenex

Jan. 5 --Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD).

The details can be read here.

No comments: