Office of New Drugs directs the Division of
Cardiology and Nephrology to work with Ardelyx to develop a label
to support the commercialization of XPHOZAH; Ardelyx to resubmit
NDA in the first half of 2023
Upon approval, XPHOZAH would be the first and
only phosphate absorption inhibitor, offering patients a novel
mechanism
Conference call to be held Dec. 29, 2022, at 8:00 AM
ET
WALTHAM,
Mass., Dec. 29, 2022 /PRNewswire/ -- 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 Office of New Drugs (OND), Center for Drug
Evaluation and Research of the U.S. Food and Drug Administration
(FDA) granted the appeal to the Complete Response Letter (CRL) for
the New Drug Application (NDA) for XPHOZAH.
In the response letter, OND directed the FDA's Division of
Cardiology and Nephrology (DCN) to work with Ardelyx to develop an
appropriate label. Ardelyx believes that a label could reflect an
indication for patients whose hyperphosphatemia is insufficiently
managed on binder therapy. In addition, the letter guided Ardelyx
to request a meeting with the DCN to determine specific information
that will form the basis for resubmission of the NDA for XPHOZAH.
Ardelyx will request this meeting as soon as possible to enable the
company to resubmit the NDA in the first half of 2023.
"By granting the appeal, we believe that OND has sent a powerful
message regarding the importance of bringing innovation to the more
than 400,000 patients on dialysis who struggle every day, at every
meal, to control their phosphorus levels and yet are unable to do
so. For more than 60 years, the only choice physicians had for
patients has been phosphate binders, and the patients have
desperately needed novel mechanism therapies. This is a momentous
day for Ardelyx and for all the members of the broader kidney
disease community who have supported the development of XPHOZAH
over the past ten years," said Mike
Raab, president and chief executive officer of Ardelyx. "We
appreciate the FDA's responsiveness to the clear guidance from the
Cardiovascular and Renal Drugs Advisory Committee, recognizing the
importance of providing a novel therapy for physicians. This could
not have been accomplished without the support from members of the
kidney community who spoke at the Advisory Committee meeting about
the significant unmet patient need and the important role XPHOZAH
could play in the hyperphosphatemia treatment paradigm. We look
forward to working with the FDA to bring this important medicine to
patients and their treating physicians."
Kevin Martin, M.D., Professor of
Internal Medicine in the Division of Nephrology at St. Louis University, added, "This FDA decision is
extremely positive for the kidney community and brings us one step
closer to having a much-needed novel therapy for the treatment of
hyperphosphatemia. The majority of patients are in need of a
different approach, as today, despite best efforts with phosphate
binders, close to 80% of patients are unable to consistently
achieve guideline-established target serum phosphate levels. In
clinical trials, XPHOZAH, with its unique mechanism of action that
blocks intestinal phosphate transport, provided clinically
meaningful reductions in serum phosphate with one small pill twice
a day. As was clear during last month's Advisory Committee meeting,
patients and physicians are anxious to have access to XPHOZAH."
The OND's decision follows a favorable outcome of the
November 16, 2022 CRDAC meeting,
where the Advisory Committee voted nine to four that the benefits
of treatment with XPHOZAH outweigh its risks for the control of
serum phosphorus in adults with chronic kidney disease (CKD) on
dialysis when administered as a monotherapy, and voted ten to two,
with one abstention, that the benefits of treatment with XPHOZAH in
combination with phosphate binder treatment outweigh its risks. The
NDA for XPHOZAH for the control of serum phosphorus is supported by
a comprehensive development program involving more than 1,200
patients and included three Phase 3 clinical trials, all of which
met their primary and key secondary endpoints. Upon approval,
XPHOZAH would be the first and only phosphate absorption inhibitor
for adult patients with CKD on dialysis with hyperphosphatemia.
Conference Call Information
The company will host a
conference call on December 29, 2022,
at 8:00 AM ET. To participate in the
conference call, please call (866) 374-5140 (toll-free) or (404)
400-0571 (toll) and reference call ID number 65128972#. A webcast
of the call can also be accessed by visiting the Investor page of
the company's website at www.ardelyx.com and will be available on
the website for 30 days following the call.
About XPHOZAH (tenapanor) for
Hyperphosphatemia
XPHOZAH (tenapanor), discovered and
developed by Ardelyx, is an investigational first-in-class
phosphate absorption inhibitor (PAI). XPHOZAH, with its unique
blocking mechanism of action, acts locally in the gut to inhibit
the sodium hydrogen exchanger 3 (NHE3), reducing phosphate
absorption through the paracellular pathway, the primary pathway of
phosphate absorption. This novel blocking mechanism enables a one
30 mg tablet BID (twice daily) dosing regimen. The most common side
effect with XPHOZAH in clinical trials was diarrhea.
About Hyperphosphatemia
Elevated levels of serum
phosphorus in the blood, or hyperphosphatemia (HP), is a serious
condition resulting in an abnormally elevated level of phosphorus
in the blood that is estimated to affect more than 745,000 dialysis
patients in major developed countries. The kidney is the organ
responsible for regulating phosphorus levels, but when kidney
function is significantly impaired, phosphorus is not adequately
eliminated from the body. As a result, hyperphosphatemia is a
nearly universal condition among people with CKD on dialysis with
internationally recognized KDIGO treatment guidelines that
recommend lowering elevated phosphate levels toward the normal
range (2.5-4.5mg/dL).
The only adverse reaction reported in more than 5% of patients
treated with XPHOZAH in the Phase 3 trials was diarrhea, with an
incidence of 47%. The majority of these events occurred during the
26-week randomized treatment period and were mild-to-moderate in
severity and transient in nature, occurring soon after initiation
of treatment, and generally resolving with continued treatment.
Severe diarrhea was reported in 5% of XPHOZAH-treated patients in
these trials.
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's
first approved product, IBSRELA® (tenapanor) is
available in the United States and
Canada. Ardelyx is developing
XPHOZAH® (tenapanor), a novel product candidate for the
management of hyperphosphatemia in adult patients with CKD on
dialysis, which has completed three successful Phase 3 trials.
Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the
potential treatment of elevated serum potassium, or hyperkalemia, a
problem among certain patients with kidney and/or heart disease and
an early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. Ardelyx has established agreements
with Kyowa Kirin in Japan, Fosun
Pharma in China and Knight
Therapeutics in Canada for the
development and commercialization of tenapanor in their respective
territories. For more information, please visit
https://ardelyx.com/ and connect with us on Twitter @Ardelyx,
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, Ardelyx's expectation
regarding the timing of the resubmission of the NDA for XPHOZAH;
Ardelyx's expectation regarding the development of a label for the
commercialization of XPHOZAH; Ardelyx's belief regarding what
indication may be included in such label; and Ardelyx's
expectations regarding the opportunity to bring XPHOZAH to patients
and treating physicians. 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 regulatory approval process. 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
November 3, 2022, and its future
current and periodic reports to be filed with the Securities and
Exchange Commission.
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SOURCE Ardelyx