CAMBRIDGE, Mass., Sept. 28,
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 it has resubmitted its New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for vadadustat, Akebia's
investigational oral hypoxia-inducible factor prolyl hydroxylase
inhibitor, for the treatment of anemia due to chronic kidney
disease (CKD) in adult patients on dialysis. Vadadustat is
currently approved for use in 35 countries.
"We are pleased to have resubmitted the NDA for vadadustat
following multiple discussions with the FDA and clear direction
from the agency, a significant milestone that reflects our team's
commitment to patients and conviction in the benefit we believe
vadadustat can deliver to patients on dialysis," said John P. Butler, Chief Executive Officer of
Akebia. "Our team assembled a comprehensive resubmission, which now
includes post-marketing safety data from tens of thousands of
patients in Japan where vadadustat
is approved and has been in market for more than three years. We
look forward to working with the FDA during the review process and
are eager to offer a new oral therapeutic to patients if
approved."
Based on standard NDA resubmission review timelines, a letter
from the FDA acknowledging that the resubmission is complete,
classifying the resubmission, and setting the PDUFA date is
expected in 30 days. Akebia expects the FDA to set a PDUFA date of
six months from the date of submission.
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. The Company
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 Japan as a treatment for
anemia due to CKD in both dialysis-dependent and non-dialysis
dependent adult patients.
Forward-Looking Statement
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 beliefs about the comprehensive
nature of its NDA resubmission for vadadustat and expectations
regarding the acceptance by the FDA and a decision by the FDA on
its NDA for vadadustat, including the timing thereof; Akebia's
beliefs about the benefits vadadustat can deliver to patients on
dialysis; and Akebia's plans with respect to commercializing
vadadustat in the U.S. if approved. 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.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics