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

2023-10-18

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临床结果临床3期上市批准引进/卖出

XPHOZAH has been approved 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 blocks the absorption of phosphate with a single tablet taken twice daily

Commercial launch underway with product expected to be available in November

Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (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.

“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,” said Mike Raab, president and chief executive officer of 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. This therapy was born in our labs in 2008, and to now see it becoming available for patients is truly a testament to the dedication, outstanding execution, and sense of mission of the Ardelyx team. This approval is also a tribute to the patients, families, physicians and clinical trial personnel who participated in the development of XPHOZAH. There is a high level of anticipation and enthusiasm for the launch of XPHOZAH from the kidney community, and our world-class team will enter the marketplace well positioned with a first-in-class product.”

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 3 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.

About XPHOZAH® (tenapanor)

XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full Prescribing Information.

About Hyperphosphatemia

Hyperphosphatemia is a serious condition, defined as resulting in elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL).

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