Ardelyx Responds to District Court Decision Granting Motion to Dismiss
Ardelyx (ARDX) faces a setback as the U.S. District Court dismisses their lawsuit against CMS's decision to include oral-only phosphate-lowering therapies in the ESRD PPS starting January 1, 2025. This decision affects XPHOZAH, Ardelyx's FDA-approved therapy for reducing serum phosphorus in adults with chronic kidney disease on dialysis. The company argues this inclusion in the bundled payment system will restrict patient access to essential medications. CEO Mike Raab expressed disappointment, stating the decision could harm dialysis patients' access to optimal care. Ardelyx is reviewing the court's decision and considering all legal options while urging Congress to pass the Kidney PATIENT Act.
Ardelyx (ARDX) affronta una battuta d'arresto poiché il Tribunale Distrettuale degli Stati Uniti ha respinto la loro causa contro la decisione del CMS di includere le terapie fosfato-lowering solo orali nel PPS per l'ESRD a partire dal 1 gennaio 2025. Questa decisione colpisce XPHOZAH, la terapia approvata dalla FDA di Ardelyx per ridurre il fosforo sierico negli adulti con malattia renale cronica in dialisi. L'azienda sostiene che questa inclusione nel sistema di pagamento a pacchetto limiterà l'accesso dei pazienti a farmaci essenziali. Il CEO Mike Raab ha espresso delusione, affermando che la decisione potrebbe danneggiare l'accesso dei pazienti in dialisi a cure ottimali. Ardelyx sta esaminando la decisione del tribunale e considerando tutte le opzioni legali, mentre esorta il Congresso ad approvare il Kidney PATIENT Act.
Ardelyx (ARDX) enfrenta un revés después de que el Tribunal de Distrito de EE. UU. desestimara su demanda contra la decisión de CMS de incluir terapias para reducir el fosfato solo por vía oral en el PPS de ESRD a partir del 1 de enero de 2025. Esta decisión afecta a XPHOZAH, la terapia aprobada por la FDA de Ardelyx para reducir el fósforo sérico en adultos con enfermedad renal crónica en diálisis. La empresa argumenta que esta inclusión en el sistema de pago agrupado restringirá el acceso de los pacientes a medicamentos esenciales. El CEO Mike Raab expresó su decepción, afirmando que la decisión podría perjudicar el acceso de los pacientes en diálisis a una atención óptima. Ardelyx está revisando la decisión del tribunal y considerando todas las opciones legales, mientras insta al Congreso a aprobar la Ley Kidney PATIENT.
Ardelyx (ARDX)는 미연방지방법원이 CMS의 결정을 상대로 한 소송을 기각함에 따라 난관에 봉착했습니다. 이 결정은 2025년 1월 1일부터 ESRD PPS에 구강으로만 복용하는 인산염 저하 치료제를 포함하는 것을 말합니다. 이 결정은 Ardelyx의 FDA 승인 치료제인 XPHOZAH에 영향을 미치며, 이는 투석 중인 만성 신장 질환 성인의 혈청 인산을 줄이기 위해 고안되었습니다. 회사는 이 포장된 지불 시스템에 포함됨으로써 환자들이 필수 의약품에 접근하는 데 제한이 있을 것이라고 주장하고 있습니다. CEO Mike Raab는 이 결정이 투석 환자들이 최적의 치료를 받을 수 있는 접근 방식에 해를 끼칠 수 있다고 경을 표했습니다. Ardelyx는 법원의 결정을 검토하고 모든 법적 옵션을 고려하고 있으며, 의회에 Kidney PATIENT 법안을 통과시킬 것을 촉구하고 있습니다.
Ardelyx (ARDX) fait face à un revers alors que le tribunal de district des États-Unis rejette leur poursuite contre la décision de CMS d'inclure les thérapies orales pour abaisser le phosphate dans le PPS ESRD à partir du 1er janvier 2025. Cette décision affecte XPHOZAH, le traitement approuvé par la FDA d'Ardelyx pour réduire le phosphore sérique chez les adultes atteints de maladie rénale chronique sous dialyse. La société soutient que cette inclusion dans le système de paiement groupé limitera l'accès des patients à des médicaments essentiels. Le PDG Mike Raab a exprimé sa déception, affirmant que la décision pourrait nuire à l'accès des patients dialysés à des soins optimaux. Ardelyx examine la décision du tribunal et envisage toutes les options juridiques tout en exhortant le Congrès à adopter la loi Kidney PATIENT.
Ardelyx (ARDX) sieht sich einem Rückschlag gegenüber, da das US-Bezirksgericht ihre Klage gegen die Entscheidung des CMS abweist, orale Phosphat-senkende Therapien im ESRD PPS ab dem 1. Januar 2025 einzuschließen. Diese Entscheidung betrifft XPHOZAH, die von der FDA genehmigte Therapie von Ardelyx zur Senkung des Serumphosphors bei Erwachsenen mit chronischer Nierenerkrankung in Dialyse. Das Unternehmen argumentiert, dass diese Einbeziehung im Pauschalzahlungssystem den Zugang der Patienten zu lebenswichtigen Medikamenten einschränken wird. Der CEO Mike Raab äußerte seine Enttäuschung und erklärte, dass die Entscheidung den Zugang von Dialysepatienten zu optimaler Versorgung beeinträchtigen könnte. Ardelyx prüft die Entscheidung des Gerichts und überlegt alle rechtlichen Optionen, während es den Kongress auffordert, das Kidney PATIENT Gesetz zu verabschieden.
- XPHOZAH maintains FDA approval as an add-on therapy for phosphorus reduction in CKD patients on dialysis
- Company maintains ability to market XPHOZAH outside the ESRD PPS bundle
- Court dismissal allows CMS to include XPHOZAH in ESRD PPS bundle starting January 1, 2025
- Bundled payment system may restrict patient access and potentially impact XPHOZAH sales
- Legal setback could affect market penetration and revenue potential
Insights
The District Court's dismissal of Ardelyx's lawsuit against CMS represents a significant setback for the company's commercialization strategy for XPHOZAH. The decision allows CMS to include oral phosphate-lowering therapies in the ESRD PPS bundle starting January 1, 2025, which will likely impact XPHOZAH's market penetration and revenue potential. By including these medications in the bundled payment system, dialysis providers will bear the cost, potentially creating access barriers and reducing prescription rates.
The company's decision to not apply for Transitional Drug Add-on Payment Adjustment (TDAPA) is a strategic move to maintain physician-patient autonomy in treatment decisions, but it could affect near-term revenue opportunities. The focus on legislative intervention through the Kidney PATIENT Act suggests a parallel strategy to overcome reimbursement challenges, though success remains uncertain.
This regulatory setback could significantly impact Ardelyx's commercial prospects for XPHOZAH. The bundled payment system typically leads to restricted use of newer, more expensive medications as dialysis providers must absorb the costs within their fixed reimbursement. Historical patterns show that drugs included in the bundle face adoption challenges, which could limit XPHOZAH's market penetration despite its novel mechanism of action and proven efficacy. The timing of this decision, coming shortly after XPHOZAH's FDA approval, creates near-term uncertainty for revenue projections and may require adjustments to market forecasts.
Inclusion of oral-only phosphate-lowering therapies in the ESRD PPS will put dialysis patients’ health at risk
WALTHAM, Mass., Nov. 08, 2024 (GLOBE NEWSWIRE) -- 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 confirmed that Judge Beryl Howell from the U.S. District Court for Washington, D.C. has granted defendants’ motion to dismiss the lawsuit filed by Ardelyx, the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF), permitting the Centers for Medicare and Medicaid Services (CMS) to proceed with its plan to include XPHOZAH® (tenapanor) and other oral-only phosphate lowering therapies (PLTs) in the End-Stage Renal Disease Prospective Payment System (ESRD PPS).
“We are disappointed and saddened by the Court’s decision to grant defendants’ motion to dismiss allowing CMS to bring PLTs into the Medicare ESRD PPS beginning on January 1, 2025. This will result in incredible harm to dialysis patients who, as a result of the bundled payment system, are unable to access the best care and medicine they require. Dialysis patients are among those who have historically experienced poorer health outcomes due to negative social determinants of health. And, while addressing health disparities has been a stated goal for CMS, this policy moves us in the opposite direction, resulting in severely restricted access to important medications,” said Mike Raab, president and chief executive officer of Ardelyx.
Raab continued, “Today’s decision reinforces our commitment to pursue all means for protecting patient access to XPHOZAH, including our choice not to apply for TDAPA in order to preserve the shared decision-making process between patients and healthcare providers who can best determine the best course of therapy to manage hyperphosphatemia. We also urge Congress to act swiftly on the overwhelming pleas from patients, physicians, faith leaders, labor unions and health equity advocates across the nation to pass the Kidney PATIENT Act.”
Ardelyx is currently reviewing the District Court’s decision and will consider all options related to the lawsuit.
XPHOZAH was approved by the U.S. Food and Drug Administration in October 2023 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. Eighty percent of patients with CKD on dialysis require prescription therapy to lower elevated levels of serum phosphorus. Phosphate binders are not sufficient for a majority of patients to achieve and maintain phosphorus levels within target range. 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.
About Hyperphosphatemia
Hyperphosphatemia is a serious condition, defined as 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).
IMPORTANT SAFETY INFORMATION (XPHOZAH)
CONTRAINDICATIONS
XPHOZAH is contraindicated in:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONS
Diarrhea
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONS
Diarrhea, which occurred in 43
INDICATION
XPHOZAH (tenapanor), 30 mg BID, is 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.
For additional safety information, please see full Prescribing Information.
About Ardelyx
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the impact that moving XPHOZAH and PLTs into the ESRD PPS will have on patient access, the impact that our choice not to apply for TDAPA will have on the shared decision-making process between patients and healthcare providers, and the clinical benefit of XPHOZAH. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2024, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Investor and Media Contacts:
Caitlin Lowie
clowie@ardelyx.com
FAQ
What was the outcome of Ardelyx's (ARDX) lawsuit against CMS?
How will the court decision affect ARDX's XPHOZAH accessibility?
What is XPHOZAH's current FDA approval status for ARDX?
