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, in partnership with the American Association
of Kidney Patients (AAKP), the nation’s largest independent kidney
patient organization, and the National Minority Quality Forum
(NMQF), the nation's largest minority healthcare research,
education and advocacy organization, it has filed a lawsuit against
the U.S. Department of Health and Human Services and the Centers
for Medicare and Medicaid Services (CMS), claiming that CMS’s plan
to include XPHOZAH® (tenapanor), along with all other oral-only
phosphate lowering therapies (PLTs), in the End-Stage Renal Disease
Prospective Payment System (ESRD PPS) will significantly and
negatively impact patient choice of and timely access to important
medications.
The lawsuit claims that CMS has violated its statutory and
regulatory authority under the Medicare Improvements for Patients
and Providers Act (MIPPA), which established the ESRD PPS bundled
payment system for dialysis services in 2008. Specifically, the
lawsuit claims that CMS’s plan to move XPHOZAH, along with all
oral-only PLTs, into the ESRD PPS is inconsistent with MIPPA’s
statutory provision, and contradicts CMS’s own regulations. XPHOZAH
and other PLTs, which are currently available to patients under
outpatient pharmacy benefit plans such as Medicare Part D, are not
administered by dialysis providers and cannot be taken during the
delivery of maintenance dialysis. The plaintiffs seek relief under
the Administrative Procedure Act to enjoin CMS from proceeding with
its plan to include XPHOZAH in the ESRD PPS and eliminate coverage
under Medicare Part D beginning on January 1, 2025.
“It is abundantly clear that moving XPHOZAH and other PLTs into
the ESRD PPS will result in the imposition of severe care choice
and timely access restrictions for all dialysis patients. The
planned move by CMS will continue to create disincentives for the
development of new and important medicines that can improve patient
health and address unmet needs in an already underserved
therapeautic area,” said Mike Raab, president and chief executive
officer of Ardelyx. “In the eight months that our first-in-class
phosphate absorption inhibitor, XPHOZAH, has been in clinical use,
many patients have now been able to achieve and maintain phosphorus
levels within the target range. Patients with elevated phosphorus
have few options to improve their condition and are now at risk of
losing choice and timely access to a brand new, FDA-approved
therapy that is providing them a meaningful clinical benefit. This
lawsuit attempts to stop CMS’s continued harmful statutory
overreach and better protect dialysis patients’ choice and timely
access to important new therapies.”
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 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 HyperphosphatemiaHyperphosphatemia 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
PRECAUTIONSDiarrhea 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 43-53% of patients, was the only adverse reaction
reported in at least 5% 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
5% of XPHOZAH-treated patients in these trials.
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 ArdelyxArdelyx 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.
About the American Association of Kidney Patients
(AAKP) Since 1969, AAKP has been a patient-led
organization driving policy discussions on kidney patient care
choice and medical innovations to improve patient lives and prevent
avoidable illness and death. AAKP advocates played a central role
in the Congressional authorization of the modern ESRD program and
coverage for dialysis and transplantation. Over the past decade,
AAKP patient advocates have helped advance lifetime transplant drug
coverage for kidney transplant recipients (2020); the presidential
Executive Order on Advancing American Kidney Health (2019); new job
protections for living organ donors under the Family Medical Leave
Act (FMLA) via the U.S. Department of Labor (2018); and
Congressional legislation allowing HIV-positive organ transplants
for HIV-positive patients (2013). Follow AAKP on social media at
@kidneypatient on Facebook, @kidneypatients on Twitter, and
@kidneypatients on Instagram, and visit http://www.aakp.org for
more information.
About National Minority Quality ForumThe
National Minority Quality Forum (NMQF) is a 501(c)(3)
not-for-profit research and advocacy organization based in
Washington, DC. The mission of NMQF is to reduce patient risk by
assuring optimal care for all. NMQF’s vision is an American health
services research, delivery and financing system whose operating
principle is to reduce patient risk for amenable morbidity and
mortality while improving quality of life. For more information,
please visit www.nmqf.org.
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 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 May 2, 2024, and its future
current and periodic reports to be filed with the Securities and
Exchange Commission.
Investor and Media Contacts: Caitlin
Lowieclowie@ardelyx.com
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