FDA approves Tenapanor for chronic kidney disease

The FDA approved tenapanor (Xphozah; Ardelyx, Inc.), making it the first and only phosphate absorption inhibitor approved to reduce serum phosphorus in adults with chronic kidney disease (CKD). Hemodialysis as an adjunctive therapy in patients with chronic kidney disease (CKD). who do not respond to phosphate binders or who do not tolerate any dose of phosphate binder treatment. According to Ardelyx’s press release, the pill is taken twice daily and provides a first-in-class mechanism of action that helps block the absorption of phosphate through its main pathway.

Tenapanor is a first-in-class phosphate absorption inhibitor with a distinct mechanism of action that operates in the intestine. It interferes with sodium hydrogen 3 (NHE3) exchange, reducing phosphate absorption through the paracellular pathway, which is the main route of phosphate absorption.

Glenn Chertow, MD, MPH, professor of medicine, Stanford University, said in a press release that managing hyperphosphatemia is a persistent clinical challenge because the majority of patients receive dialysis alone. persistent inability to consistently achieve target serum phosphate concentrations despite treatment with phosphate binders. . [Tenapanor] is not a phosphate binder. [Tenapanor] is a phosphate absorption inhibitor. In patients who do not respond adequately to phosphate binding therapy, [tenapanor] has been shown to increase the proportion of patients achieving target serum phosphate concentrations. I believe [tenapanor] may advance the care of patients with hyperphosphatemia, providing a new treatment option with an additional mechanism of action.

The FDA approval is the result of three phase 3 clinical trials PHREEDOM, BLOCK, and AMPLIF that evaluated the efficacy and safety of tenapanor as both monotherapy and as combination therapy with phosphate binding therapy. These three trials met key primary and secondary endpoints and demonstrated that tenapanor significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis. Furthermore, there are 2 open-label clinical trials, OPTIMIZE and NORMAL, that have evaluated different options for integrating tenapanor into clinical practice.

The most common adverse event (AE) experienced by patients in the trials was diarrhea, which occurred shortly after onset in 43% to 53% of patients and in at least 5% of patients with CKD. treated with tenapanor were on hemodialysis throughout the trials. Most reported occurrences were mild to moderate in severity and resolved with time or dose reduction. Severe diarrhea is less common and was reported in only 5% of patients treated with tenapanor in trials. Tenapanor is not recommended for pediatric patients under 6 years of age or for patients with known or suspected mechanical gastrointestinal obstruction.

Approval of [tenapanor] is an important milestone for dialysis patients, their families, and the kidney care community, as it represents a new mechanism and new options for patients who, despite being treated with phosphate binders, emissions, there continues to be elevated phosphorus levels, Mike Raab, CEO and president of Ardelyx, said in the press release. This approval is also a tribute to the patients, families, physicians and clinical trial staff who participated in its development. [tenapanor]. There was a high level of anticipation and enthusiasm for the launch [tenapanor] from the kidney community, and [Ardelyxs] The world-class team will enter the market well positioned with first-class products.

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Ardelyx. FDA approves XPHOZAH (tenapanor), a first-in-class phosphate absorption inhibitor. New information posted. October 17, 2023. Accessed October 18, 2023. https://ir.ardelyx.com/news-releases/news-release-details/fda-approves-xphozahr-tenapanor-first-class-phosphate- ababsorb