March 27, 2024 Set
as User Fee Goal Date
CAMBRIDGE, Mass., Oct. 25,
2023 /PRNewswire/ -- Akebia
Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical
company with the purpose to better the lives of people impacted by
kidney disease, today announced the U.S. Food and Drug
Administration (FDA) has acknowledged that the resubmission to its
New Drug Application (NDA) for vadadustat as a treatment for anemia
due to chronic kidney disease (CKD) in adult patients on dialysis,
was complete. The FDA has classified this as a class 2 response,
which results in a six-month review period from the date of
resubmission, and the FDA set a user fee goal date ("PDUFA" date)
of March 27, 2024.
"We're extremely pleased the FDA acknowledged our resubmission
to our NDA for vadadustat was complete following our productive
interactions over the past year. We look forward to working closely
with the agency to finalize the review," said John P. Butler, Chief Executive Officer of
Akebia. "With this significant milestone, we expect to have
vadadustat available shortly following an approval and are
preparing for a commercial launch in the second half of 2024 as we
are eager to offer an alternative oral medication to U.S. dialysis
patients if approved."
Akebia's resubmission to its NDA addressed the issues raised in
the complete response letter. The filing included post-marketing
safety data from tens of thousands of patients in Japan where
vadadustat is approved and has been on the market for more than
three years. Vadadustat is currently approved for use in 35
countries.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is
a fully integrated biopharmaceutical company with the purpose to
better the lives of people impacted by kidney disease. Akebia was
founded in 2007 and is headquartered in Cambridge, Massachusetts. For more
information, please visit our website at www.akebia.com, which does
not form a part of this release.
About Vadadustat
Vadadustat is an oral
hypoxia-inducible factor prolyl hydroxylase inhibitor designed to
mimic the physiologic effect of altitude on oxygen availability. At
higher altitudes, the body responds to lower oxygen availability
with stabilization of hypoxia-inducible factor, which can lead to
increased red blood cell production and improved oxygen delivery to
tissues. Vadadustat is not approved by the U.S. Food and Drug
Administration. Vadadustat is approved in 35 countries, including
Europe and Australia, for the treatment of symptomatic
anemia due to CKD in adult patients on chronic maintenance dialysis
and in Japan as a treatment for
anemia due to CKD in both dialysis-dependent and
non-dialysis-dependent adult patients.
Forward-Looking Statements
Statements in this press
release regarding Akebia Therapeutics, Inc.'s ("Akebia's")
strategy, plans, prospects, expectations, beliefs, intentions and
goals are forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995, as amended, and
include, but are not limited to, statements regarding: Akebia's
expectations regarding the a decision by the FDA on its NDA for
vadadustat, including the timing thereof; and Akebia's plans with
respect to commercializing vadadustat in the U.S. if approved,
including the timing thereof. The terms "intend," "believe,"
"plan," "goal," "expect," "potential," "anticipate," "will,"
"continue," derivatives of these words, and similar references are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results, performance or experience may differ materially from those
expressed or implied by any forward-looking statement as a result
of various risks, uncertainties and other factors, including, but
not limited to, risks associated with: decisions made by health
authorities, such as the FDA, with respect to regulatory filings,
including the anticipated FDA decision on the NDA for vadadustat;
the potential therapeutic benefits, safety profile, and
effectiveness of vadadustat; the potential demand and market
potential and acceptance of, as well as coverage and reimbursement
related to, Auryxia, including estimates regarding the potential
market opportunity; the competitive landscape for Auryxia,
including potential generic entrants; the ability of Akebia to
attract and retain qualified personnel; Akebia's ability to
implement cost avoidance measures and reduce operating expenses;
the results of preclinical and clinical research; the direct or
indirect impact of the COVID-19 pandemic on regulators and Akebia's
business, operations, and the markets and communities in which
Akebia and its partners, collaborators, vendors and customers
operate; manufacturing, supply chain and quality matters and any
recalls, write-downs, impairments or other related consequences or
potential consequences; and early termination of any of Akebia's
collaborations. Other risks and uncertainties include those
identified under the heading "Risk Factors" in Akebia's Quarterly
Report on Form 10-Q for the quarter ended June 30, 2023, and other filings that Akebia may
make with the U.S. Securities and Exchange Commission in the
future. These forward-looking statements (except as otherwise
noted) speak only as of the date of this press release, and, except
as required by law, Akebia does not undertake, and specifically
disclaims, any obligation to update any forward-looking statements
contained in this press release.
Akebia Therapeutics® is a registered trademark of
Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics