Keryx Gets SPA Agreement with FDA for Phase III Registration Program of Zerenex

Keryx Biopharmaceuticals, Inc. announced Tuesday 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 (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease.
Earth Times