Tag Archive for: tenapanor

The company’s resubmission succeeded in getting the greenlight for tenapanor, now to be marketed as Xphozah, to lower serum phosphorus levels in chronic kidney disease patients.

After examining the available information and hearing the testimony of CKD patients who participated in the clinical studies, the majority of the committee agreed the benefits of the medication outweighed its risks as a monotherapy.

FDA staff reviewers raised concerns over unclear benefits of Ardelyx Inc.’s drug for kidney disease patients, stating, “the magnitude of treatment effect appears less than that observed with approved drugs,” in briefing documents released on Monday.

On Nov.16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to assess the data supporting Ardelyx’s New Drug Application for tenapanor in chronic kidney disease.