FDA Committee Recommends Ardelyx Kidney Disease Drug

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Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.

Ardelyx, a biopharmaceutical company focusing on medicines that meet significant unmet medical needs, announced positive findings from FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting concerning XPHOZAH (tenapanor) on Nov. 16, 2022. While it was once rejected by FDA, the panel voted for its approval as a treatment for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. It received a majority vote as both a monotherapy and combination treatment with phosphate binder.

According to a company press release, tenapanor is an investigational first-in-class phosphate absorption inhibitor with a unique blocking mechanism of action, which acts locally in the gut to inhibit the sodium hydrogen exchanger 3. This reduces phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption, allowing for control of serum phosphorus in the patient's blood. The drug is taken as a 30 mg tablet twice daily.

CRDAC based its decision on findings concerning tenapanor on a comprehensive development program that included more than 1,200 patients in three Phase III clinical trials that evaluated its safety and efficacy. According to the release, all the trials met their primary and key secondary endpoints.

"Today's vote by the CRDAC is a promising development for the chronic kidney disease community, as patients continue to struggle to control serum phosphorus levels despite [the] use of currently available therapies, which are all limited to the phosphate binder class," said Mike Raab, president and CEO, Ardelyx, in the release. "We are hopeful following today's discussion that the data, the opinion of the advisory committee, the needs of patients, and the compelling voice of the broader nephrology community will be reflected in the FDA's decision on our appeal."


"[Tenapanor] is a novel treatment that provides a clinically meaningful effect on serum phosphate,” said Sharon Moe, chief of the division of nephrology and hypertension at Indiana University School of Medicine, in the release. I am encouraged by the committee's vote. The nephrology community is enthusiastic to have access to this therapy with its novel mechanism of action to help our patients."

While CRDAC’s recommendations are not binding, they will be considered by FDA’s Office of New Drugs (OND) when making its decision on Ardelyx’s appeal for tenapanor. OND is expected to provide a response to the appeal within thirty days.

Source: Ardelyx