Ardelyx Announces XPHOZAH® (tenapanor) Now Available in the United States
06 Noviembre 2023 - 7:00AM
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 XPHOZAH is now available for shipment to partner
pharmacies. XPHOZAH® (tenapanor) 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. 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 kidney community has been waiting a long time for another
option to help manage hyperphosphatemia and we are proud to
announce that XPHOZAH is now being shipped to our partner
pharmacies,” said Mike Raab, president and chief executive officer
of Ardelyx. “We look forward to engaging with healthcare providers
and supporting patient access and affordability for this new
therapeutic option with a differentiated mechanism of action.”
Ardelyx 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.
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 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
October 31, 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
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