Tag Archive for: Ardelyx

The FDA’s schedule is picking up speed, with six target action dates over the next two weeks, including one for a blockbuster cancer treatment and another for a highly anticipated therapy for a rare pediatric disorder.

Ardelyx, Inc. announced that the Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH

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.