FREMONT, Calif. and
WALTHAM, Mass., Nov. 4, 2021 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), a biopharmaceutical company focused on the
discovery, development, and commercialization of innovative
first-in-class medicines to improve treatment for people with
kidney and cardiorenal diseases, today announced the company plans
to submit a Formal Dispute Resolution Request (FDRR) to appeal the
issuance of a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) for the company's New Drug Application
(NDA) for tenapanor for the control of serum phosphorus in adult
patients with chronic kidney disease (CKD) on dialysis. Formal
Dispute Resolution is a pathway in the Center for Drug Evaluation
and Research (CDER) by which NDA applicants can seek to resolve
scientific and/or medical disputes that cannot be resolved at the
division level.
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"While we are disappointed that we could not come to a
resolution with the Division of Cardiology and Nephrology during
the End of Review meeting, the Formal Dispute Resolution process
provides an opportunity to raise our scientific disagreement above
the division level within CDER," said Mike
Raab, president and chief executive officer of Ardelyx.
"We believe that this represents the best approach to obtaining
approval of tenapanor for the treatment of hyperphosphatemia and
bringing this important medicine forward to patients and their
treating physicians."
"Phosphorus management is one of the most challenging aspects of
caring for patients on dialysis," said Stuart Sprague, DO, FASN, FNKF, chief of the
Division of Nephrology and Hypertension at Northshore University
Health System, University of Chicago. "Despite our best
efforts with currently available therapies, all of which act via
the binding mechanism, nearly 80% of patients are unable to
consistently achieve target phosphorus levels established by
peer-reviewed global treatment guidelines, in spite of taking up to
10-12 pills per day. Thus, there is a strong need for a novel
therapeutic approach, such as that of tenapanor, which blocks
gastrointestinal phosphate absorption. The tenapanor clinical data
package demonstrates that a significant proportion of patients
respond to therapy with meaningful reductions in phosphorus with
only 2 pills per day, and an acceptable safety and tolerability
profile. The clinical relevance of tenapanor is clear. In addition,
the meaningful impact tenapanor will have on the patient experience
cannot be ignored. The delay in approval by the FDA is not in the
best interest of patients. I applaud Ardelyx for their persistence
in bringing this much-needed and innovative therapy to
patients."
The company expects to submit the FDRR to the FDA's Office of
Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) in the
fourth quarter of 2021. The FDA's goal is to consider and decide on
all FDRRs in thirty (30) days with some exceptions, including if a
meeting is requested. A second appeal to the FDA's Office of New
Drugs is possible if the company does not obtain a positive outcome
from OCHEN.
About Ardelyx, Inc.
Ardelyx is focused on discovering, developing, and
commercializing innovative first-in-class medicines to enhance the
lives of patients with kidney and cardiorenal diseases. Ardelyx is
developing 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 is also
advancing RDX013, a potassium secretagogue, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease, and has an
early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. In addition, tenapanor has already
received FDA approval for the treatment of irritable bowel syndrome
with constipation (IBS-C) under the tradename IBSRELA®.
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.
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 to submit a FDRR in the fourth quarter of 2021 and
Ardelyx's expectations regarding the timing of a decision regarding
its FDRR. 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 NDA process, the FDRR process, and appeal resolution with
CDER. 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 13,
2021, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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SOURCE Ardelyx