Ardelyx Announces FDA Acceptance and Six-Month Review for Resubmission of its New Drug Application of XPHOZAH® (tenapanor)
17 Maio 2023 - 8:30AM
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 U.S. Food and Drug Administration (FDA)
has accepted its resubmission of a New Drug Application (NDA) for
XPHOZAH® (tenapanor) for the control of serum phosphate in adult
patients with chronic kidney disease on dialysis who have had an
inadequate response or intolerance to a phosphate binder therapy.
The FDA has determined that the NDA is a class 2 review, which
results in a six-month review period from the date of resubmission.
The FDA has set a user fee goal date of October 17, 2023. The
company expects XPHOZAH to be commercially available in the fourth
quarter of 2023, as soon as possible following an approval from the
FDA.
“The acceptance of our NDA is a significant milestone in our
journey to bring XPHOZAH to patients. We are excited about the
prospect of working collaboratively with the FDA to finalize this
review over the next few months,” said Mike Raab, president and
chief executive officer of Ardelyx. “We are now in full preparation
mode and intend to launch XPHOZAH to the physician and patient
communities who have patiently waited for access to this novel
therapy as soon as possible after we receive an approval
notification from the FDA, finally bringing this much-needed
treatment to patients.”
The NDA is supported by a comprehensive development program that
included 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), as well as two additional Phase 4 open-label clinical
trials (OPTIMIZE and NORMALIZE).
About XPHOZAH® (tenapanor)XPHOZAH, discovered
and developed by Ardelyx, is a first-in-class, phosphate absorption
inhibitor that has a novel mechanism of action and 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 30mg tablet twice daily dosing regimen. The most
common side effect with XPHOZAH in clinical trials was
diarrhea.
About HyperphosphatemiaHyperphosphatemia is a
serious condition resulting in an abnormally elevated level of
phosphate in the blood that is estimated to affect the vast
majority of the 550,000 patients in the United States with chronic
kidney disease (CKD) on maintenance dialysis. The kidney is the
organ responsible for regulating phosphate, but when kidney
function is significantly impaired, 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).
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 control of serum
phosphorus in adult patients with chronic kidney disease (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,
LinkedIn and Facebook.
Forward Looking StatementsTo 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 current
expectation of the review goal date for the NDA and any subsequent
commercial launch; and the potential role that tenapanor can play
in offering a new treatment option for patients with
hyperphosphatemia. 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 process for regulatory approval. 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 3, 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
Kimia Keshtbod kkeshtbod@ardelyx.com
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