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 XPHOZAHFDA 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.
Ardelyx Commitment to Patient AccessArdelyx is
committed to setting new standards in product innovation and to
setting new standards for patient support. Ardelyx will integrate
XPHOZAH into its established patient services program,
ArdelyxAssist™. ArdelyxAssist is an innovative, digital-forward
patient services program that provides access and affordability
support for patients, with integration into medical office work
processes and connectivity to patients and health care
providers.
Conference Call DetailsThe company will host a
conference call tomorrow, October 18, 2023, at 8:00 am ET to
discuss today's announcement. To participate in the conference
call, please dial (844) 481-2838 (domestic) or (412) 317-1858
(international) and ask to be joined into the Ardelyx call. A
webcast of the call can also be accessed by visiting the Investor
page of the company's website, www.ardelyx.com, and will be
available on the website for 30 days following the call.
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 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).
IMPORTANT SAFETY
INFORMATIONCONTRAINDICATIONSXPHOZAH 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 Ardelyx, Inc.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) as well as
early-stage pipeline candidates. Ardelyx has agreements for the
development and commercialization of tenapanor outside of the U.S.
Kyowa Kirin has received approval for 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 potential for XPHOZAH
to advance the care of patients with chronic kidney disease on
dialysis who have elevated levels of serum phosphorus and the
potential for ArdelyxAssist to set new standards in patient
support. 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. 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
August 2, 2023, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
Investor and Media Contacts: Caitlin
Lowieclowie@ardelyx.com
Kimia Keshtbod kkeshtbod@ardelyx.com
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