FDA approves Xphozah for the treatment of hyperphosphatemia
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Key takeaways:
- Ardelyx Inc. has received FDA approval for its phosphate drug Xphozah.
- The company said it is the first and only phosphate absorption inhibitor approved for use.
The FDA has approved Xphozah to reduce serum phosphorus in adults with chronic kidney disease on dialysis as an add-on therapy in patients who have an inadequate response to phosphate binders, according to a press release from Ardelyx Inc.
Xphozah (tenapanor) — an oral medication taken twice daily that blocks the absorption of phosphate — is the first and only phosphate absorption inhibitor indicated to reduce serum phosphorus in adults on dialysis, according to the release.
“The approval of Xphozah is an important milestone for patients on dialysis, their families and the nephrology care community, as it represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus,” Mike Raab, president and CEO of Ardelyx, said in the release. “It is also a significant accomplishment for everyone at Ardelyx. Since the founding of the company in 2007, we have been steadfast in our commitment to the kidney community, and today’s approval reinforces the compelling clinical profile and potential benefit that Xphozah may provide for so many patients.”
Glenn Chertow, MD, MPH, professor of medicine at Stanford University, said 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,” according to the release. “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.”
Xphozah was tested in more than 1,000 patients in three phase 3 clinical trials evaluating the efficacy and safety of the drug as monotherapy and in combination with phosphate binder therapy, all of which met their primary and key secondary endpoints, according to the release. Data from the three clinical trials demonstrated that Xphozah significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis, the company said.
Across trials, diarrhea — which occurred in 43% to 53% of patients — was the only adverse reaction reported in at least 5% of Xphozah-treated patients with CKD on dialysis.
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