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
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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.
