The Advisory Committee voted 9:4 in favor of
XPHOZAH as a monotherapy and 10:2 in favor of XPHOZAH in
combination with phosphate binders
The Office of New Drugs is expected to provide
a response to Ardelyx's appeal within thirty (30) days
If approved, XPHOZAH will be the first
and only phosphate absorption inhibitor, reducing serum phosphorus
with one pill taken twice daily
Conference call to be held tomorrow,
November 17, 2022, at 8:00 AM ET
WALTHAM,
Mass., Nov. 16, 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 the vote of the U.S. Food and Drug Administration's
(FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC)
meeting for XPHOZAH for the control of serum phosphorus in adult
patients with chronic kidney disease (CKD) on dialysis. The CRDAC
voted nine to four that the benefits of treatment with XPHOZAH
outweigh its risks for the control of serum phosphorus in adults
with 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.
![Ardelyx logo (PRNewsFoto/Ardelyx) (PRNewsfoto/Ardelyx) Ardelyx logo (PRNewsFoto/Ardelyx) (PRNewsfoto/Ardelyx)](https://mma.prnewswire.com/media/1309911/Ardelyx_Logo.jpg)
"Today's vote by the CRDAC is a promising development for the
chronic kidney disease community, as patients continue to struggle
to control serum phosphorus levels despite use of currently
available therapies, which are all limited to the phosphate binder
class," said Mike Raab, president
and chief executive officer of Ardelyx. "We are confident that the
data from three Phase 3 clinical trials involving more than 1,200
patients support the approval of XPHOZAH in the U.S. for the
control of serum phosphorus in adult patients with CKD on dialysis.
We want to thank the patients, physicians and the advocacy
community who shared their valuable insights today and throughout
the development program. We are hopeful following today's
discussion that the data, the opinion of the advisory committee,
the needs of patients, and the compelling voice of the broader
nephrology community will be reflected in the FDA's decision on our
appeal."
Sharon Moe, M.D., chief of the
division of nephrology and hypertension, Indiana University School of Medicine, added,
"XPHOZAH is a novel treatment that provides a clinically meaningful
effect on serum phosphate. I am encouraged by the committee's vote.
The nephrology community is enthusiastic to have access to this
therapy with its novel mechanism of action to help our
patients."
The CRDAC review of XPHOZAH for the control of serum phosphorus
in adult patients with CKD on dialysis was based on findings from a
comprehensive development program including more than 1,200
patients in three Phase 3 clinical trials evaluating the safety and
efficacy of XPHOZAH, all of which met their primary and key
secondary endpoints (PHREEDOM, BLOCK and AMPLIFY).
The CRDAC's recommendations, while not binding, will be
considered by the Office of New Drugs (OND), Center for Drug
Evaluation and Research of the FDA, when making its decision on
Ardelyx's second level appeal of the Complete Response Letter
received on July 28, 2021, for
XPHOZAH. The OND is expected to provide a response to Ardelyx's
appeal within thirty (30) days.
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 tenapanor 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).
Conference Call
Information
The company will host a conference call on November 17, 2022, at 8:00
AM ET to discuss the results of the Advisory Committee
meeting. To participate in the conference call, please call (866)
374-5140 (toll-free) or (404) 400-0571 (toll) and reference call ID
number 85570129#. 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 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 to
control serum phosphorus 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 whether the
outcome of the Advisory Committee meeting will be reflected in
FDA's decision on its appeal and Ardelyx's current expectation
regarding the timing of the OND's decision on its appeal. 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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