Ardelyx Gets FDA OK for Add-On Therapy for Kidney Disease Patients
October 17 2023 - 7:44PM
Dow Jones News
By Ben Glickman
Ardelyx has received approval from the U.S. Food and Drug
Administration for tenapanor, an add-on treatment for chronic
kidney disease patients on dialysis.
The Waltham, Mass.-based biopharmaceutical company said its
commercial launch of tenapanor, which goes by brand name Xphozah,
was underway with product expected to become available next
month.
The company said tenapanor is a phosphate absorption inhibitor
which can be given to patients on dialysis with chronic kidney
disease who don't have adequate response to phosphate binders or
who have intolerance of phosphate binder therapy.
Ardelyx's application for Xphozah was previously rejected by the
FDA, but the company appealed its rejection and its resubmission
was accepted in May.
The FDA approval was based on a Phase 3 trial of Xphozah which
met primary and key secondary endpoints.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
October 17, 2023 19:29 ET (23:29 GMT)
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