FDA approves Xphozah (tenapanor), a first-in-class phosphate absorption inhibitor to treat hyperphosphatemia- Ardelyx Inc.
Ardelyx, Inc. announced that the FDA has approved Xphozah (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
Xphozah is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
Dr. Glenn Chertow, professor of medicine, Stanford University, added, “Hyperphosphatemia management has been a persistent clinical challenge, as the majority of patients receiving maintenance dialysis are unable to consistently achieve target serum phosphate concentrations despite treatment with phosphate binders. Xphozah is not a phosphate binder. Xphozah is a phosphate absorption inhibitor. In patients not adequately responding to phosphate binder therapy, Xphozah has been shown to help increase the proportion of patients achieving target serum phosphate concentrations. I believe Xphozah can advance the care of patients with hyperphosphatemia, providing a new treatment option with a complementary mechanism of action.”
Clinical Data Supporting Xphozah : FDA approval of Xphozah is based on a comprehensive development program, including a diverse population of more than 1,000 patients in three Phase III clinical trials evaluating the efficacy and safety of Xphozah, as monotherapy and in combination with phosphate binder therapy, all of which met their primary and key secondary endpoints (PHREEDOM, BLOCK and AMPLIFY). Data from the three clinical trials demonstrated that Xphozah significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis.
Diarrhea, which occurred in 43 to 53 percent of patients, was the only adverse reaction reported in at least five percent of Xphozah-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the Xphozah-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with Xphozah. Severe diarrhea was reported in five percent of Xphozah-treated patients in these trials.
Ardelyx also completed two open-label clinical trials (OPTIMIZE and NORMALIZE) to evaluate different options for integrating Xphozah into clinical practice.
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