Keryx Biopharmaceuticals Announces Positive Top-Line Results from Phase 3 Study of Ferric Citrate

25-Apr-2012 - USA

Keryx Biopharmaceuticals, Inc. announced that its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), has announced positive top-line results from a Phase 3 study of ferric citrate in Japan for the treatment of hyperphosphatemia in end-stage renal disease patients on hemodialysis.  This study is part of an ongoing Phase 3 program for ferric citrate in Japan for the treatment of hyperphosphatemia.

The Phase 3 study, conducted in Japan, was an open-label, randomized study evaluating the efficacy and safety of ferric citrate against an active control, sevelamer hydrochloride, over 12 weeks in hemodialysis patients with hyperphosphatemia.  In the top-line results, which evaluated the change of serum phosphorus from baseline, the primary endpoint of efficacy met non-inferiority to sevelamer hydrochloride.  Furthermore, there were no clinically significant findings on safety and tolerability of ferric citrate within the treatment period.

JT/Torii stated that it is aiming to submit the marketing application for ferric citrate in Japan in the fiscal year ending March 31, 2013.

Other news from the department research and development

More news from our other portals

All FT-IR spectrometer manufacturers at a glance