FREMONT, Calif. and
WALTHAM, Mass., July 19, 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 that it received a
letter from the U.S. Food and Drug Administration (the "FDA") on
July 13, 2021, stating that, as part
of its ongoing review of the company's New Drug Application ("NDA")
for the control of serum phosphorus in adult patients with chronic
kidney disease ("CKD") on dialysis, the FDA has identified
deficiencies that preclude discussion of labeling and
post-marketing requirements/commitments at this time. The letter
stated that the notification does not reflect a final decision on
the information under review. The company immediately requested a
meeting to discuss the deficiencies and was notified by the FDA
today that the request for a meeting was denied.
While the FDA has not provided specific details regarding the
deficiencies, the FDA noted that a key issue is the size of the
treatment effect and its clinical relevance.
"This is an extremely disheartening and disappointing
communication from the FDA, particularly following the weeks of
label discussions that occurred in early April, the fact that our
NDA submission included three pivotal trials across 1,000 patients,
all which met their primary and key secondary endpoints, as well as
the additional data analyses we submitted in late April in response
to the FDA's requests," said Mike
Raab, president and chief executive officer of
Ardelyx. "We plan to work with the FDA to learn more about the
identified deficiencies and will seek to resolve them as quickly as
possible."
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
advancing tenapanor, a novel product candidate to control serum
phosphorus in adult patients with CKD on dialysis, for which the
company submitted an NDA to the FDA in June
2020. In April 2021, the FDA
extended the PDUFA date to July 29,
2021, following the submission of additional analyses
determined to be a major amendment. 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, Ardelyx received FDA approval
of IBSRELA® (tenapanor) on September 12, 2019. 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 the company's
expectations with regard to its interactions and communications
with the FDA and its plans and expectations as to the path forward
for tenapanor for the control of serum phosphorus in adult patients
with chronic kidney disease patients on dialysis. 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, whether the company will
be able to address the deficiencies identified by the FDA and
obtain regulatory approval for tenapanor. 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
May 6, 2021, and its future current
and periodic reports to be filed with the Securities and Exchange
Commission.
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SOURCE Ardelyx