FDA Approves XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor

Ardelyx, Inc., a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medical solutions, announced that the U.S. Food and Drug Administration (FDA) has granted approval for XPHOZAH® (tenapanor). XPHOZAH is the first and only phosphate absorption inhibitor designed to reduce serum phosphorus levels in adults suffering from chronic kidney disease (CKD) who are on dialysis. It is intended for use as an add-on therapy for patients who have not responded adequately to traditional phosphate binders or who are intolerant to them.

XPHOZAH is a groundbreaking advancement in the management of CKD-related hyperphosphatemia, and it achieves this with a unique mechanism of action. Patients take a single tablet of XPHOZAH twice daily, making it convenient and effective.

Mike Raab, President and Chief Executive Officer of Ardelyx, highlighted the significance of this milestone, stating, “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. It is also a significant accomplishment for everyone at Ardelyx.”

Dr. Glenn Chertow, Professor of Medicine at Stanford University, emphasized the therapeutic potential of XPHOZAH, saying, “I believe XPHOZAH can advance the care of patients with hyperphosphatemia, providing a new treatment option with a complementary mechanism of action.”

XPHOZAH’s approval by the FDA was based on comprehensive data from three Phase 3 clinical trials, including over 1,000 patients. These trials assessed the efficacy and safety of XPHOZAH as a monotherapy and in combination with phosphate binder therapy, and all met their primary and key secondary endpoints.

The most common side effect reported was diarrhea, occurring in 43 to 53 percent of patients. Most instances were mild to moderate in severity and resolved over time or with dose reduction. Only five percent of patients experienced severe diarrhea.

Ardelyx’s commitment to patient access is underscored by its innovative digital patient services program, ArdelyxAssist™, which will integrate XPHOZAH to provide support for patients, ensuring access and affordability.

Ardelyx plans to host a conference call to discuss this development on October 18, 2023, at 8:00 am ET. XPHOZAH represents a significant breakthrough for patients suffering from CKD-related hyperphosphatemia, a common and challenging condition. With this new therapy, it offers a complementary approach to improve the quality of life for these patients.

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