Ardelyx Inc (NASDAQ: ARDX), a biopharmaceutical firm focused on discovering, commercializing, and developing first-in-class medicines to enhance kidney and cardio-renal diseases treatment. Yesterday they announced that it obtained a letter on July 13, 2021, from the US Food and Drug Administration noting that as a portion of its ongoing review of the firm’s New Drug Application for the supervision of serum phosphorus in the adult patients chronic kidney disease on dialysis. As a result, the FDA has specified deficiencies that preclude the discussion of labeling and post-marketing regulations at this time. Moreover, the message asserted that the notification does not indicate a final decision on the information under review. Immediately the firm requested a meeting about deficiencies and was notified by the FDA yesterday that it refused the request for a meeting.
The FDA did not give specific details about the deficiencies, and the FDA noted that a critical issue is the size of the treatment effect and its clinical relevance.
Mike Raab’s Statement
Ardelyx’s Chief Executive Officer and President Mike Rabb said that this is incredibly disheartening and disappointing communication from the FDA. Especially following the weeks of label discussions in early April, their NDA submission comprised their pivotal trials across 1,000 patients. They met their major and minor endpoints, and the additional information analyses they submitted in April responded to the FDA’s requests. Also, he adds that they plan to work with the FDA to learn more about the identified shortcomings and seek to settle them as soon as possible.
About Ardelyx, Inc.
Ardelyx mainly concentrates on discovering, commercializing, and developing top-grade medicines to developing patients with kidney and cardio-renal diseases. Moreover, the firm is advancing tenapanor, a product candidate to control serum phosphorus in patients with CKD on dialysis, for which the firm proposed an NDA to FDA in June 2020. Also, Ardelyx is advancing RDX013, a potassium secretagogue, for the potential treatment of high serum potassium, a problem among patients certain with kidney, heart disease, and an initial stage program in metabolic acidosis.
