Ardelyx's Court Ruling: Implications for Kidney Care Access

Ardelyx Responds to Recent District Court Decision

Ardelyx, Inc. (NASDAQ: ARDX), based in Waltham, Massachusetts, is a pioneering biopharmaceutical company aimed at developing groundbreaking therapies for unmet medical needs. Recently, the company faced a decision from the U.S. District Court in Washington, D.C., which has granted a motion to dismiss a lawsuit involving Ardelyx, the American Association of Kidney Patients (AAKP), and the National Minority Quality Forum (NMQF). This ruling allows the Centers for Medicare and Medicaid Services (CMS) to go forward with its proposal to include XPHOZAH (tenapanor) and other oral-only phosphate lowering therapies (PLTs) into the Medicare End-Stage Renal Disease Prospective Payment System (ESRD PPS).

Concerns Over Patient Care

Following this decision, Ardelyx expressed deep disappointment over the implications for dialysis patients. According to Mike Raab, president and CEO of Ardelyx, the court's ruling could significantly hinder patient access to essential therapies amid ongoing changes in Medicare payment structures slated to begin in 2025. Raab emphasizes that patients relying on dialysis often confront challenges in accessing optimal care due to the systemic hurdles presented by bundled payment systems.

Advocating for Patient Rights

Raab further reinforced Ardelyx's commitment to advocate for the accessibility of XPHOZAH for patients suffering from hyperphosphatemia, a condition typically characterized by elevated phosphate levels in those with chronic kidney disease (CKD). This commitment is reflected in the decision not to seek Temporary Transitional Drug Add-on Payment Approval (TDAPA), allowing the healthcare community to maintain patient-centered decision-making in therapy management.

Ardelyx also calls on Congress to take swift action regarding the Kidney PATIENT Act, which aims to address these very concerns raised by patients, healthcare providers, and advocacy groups.

Understanding Hyperphosphatemia and Its Treatments

Hyperphosphatemia is a critical health condition prevalent among patients with chronic kidney disease on dialysis. As kidney function declines, the body struggles to eliminate excess phosphate, leading to elevated levels of phosphate in the bloodstream. The National Kidney Foundation outlines the need for targeted therapies to manage these risks effectively, making it crucial for patients to have access to innovative treatments like XPHOZAH.

XPHOZAH: A Unique Treatment Option

XPHOZAH was recently approved by the U.S. Food and Drug Administration to serve as an add-on therapy for adults with CKD on dialysis who have had insufficient responses to traditional phosphate binders or cannot tolerate them. By blocking phosphate absorption, XPHOZAH presents a unique mechanism of action, offering hope to the eighty percent of dialysis patients requiring medication to manage their phosphorus levels effectively.

Safety Information Regarding XPHOZAH

While XPHOZAH offers significant benefits, it is important for patients to be aware of its safety profile. XPHOZAH is contraindicated in pediatric patients under six years old and in individuals with certain gastrointestinal issues. The most commonly reported side effects include diarrhea, affecting a significant portion of patients undergoing treatment.

Patients starting on XPHOZAH should be closely monitored for gastrointestinal symptoms, and treatment should be adjusted as necessary to manage adverse reactions. The effectiveness of XPHOZAH hinges on proper usage and patient education regarding symptom management.

About Ardelyx and Its Mission

Ardelyx was founded with a commitment to discovering and bringing to market innovative, first-in-class therapies that address significant unmet medical needs in renal care. Their dual approach in developing and commercializing medications like IBSRELA and XPHOZAH underscores the organization's dedication to improving patient outcomes in chronic kidney disease.

For further inquiries, you can reach out to Ardelyx’s Investor and Media Contacts: Caitlin Lowie at clowie@ardelyx.com.

Frequently Asked Questions

What impact does the court ruling have on dialysis patients?

The ruling may restrict access for dialysis patients to vital medications needed to manage their health, affecting their overall care...

Why did Ardelyx decide not to apply for TDAPA?

The company aims to preserve the relationship between patients and healthcare providers, ensuring decisions around treatment plans are made collaboratively...

What is XPHOZAH used for?

XPHOZAH is indicated for reducing serum phosphorus in adults with chronic kidney disease on dialysis as an add-on therapy...

How does hyperphosphatemia affect kidney disease patients?

Elevated phosphate levels in the blood can lead to serious health complications, making it essential for kidney disease patients to manage phosphorus levels...

What is Ardelyx’s mission?

Ardelyx is dedicated to developing first-in-class therapies that respond to significant unmet medical needs, particularly in kidney care...

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