CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Akebia
Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with
the purpose of bettering the lives of people impacted by kidney
disease, today announced that it has submitted a 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
(HIF-PHI), for the treatment of anemia due to chronic kidney
disease (CKD) in both adult patients on dialysis and adult patients
not on dialysis.
"The submission of the vadadustat NDA for the treatment of
anemia due to CKD in both adult patients on dialysis and not on
dialysis marks a significant milestone not only for Akebia and our
partners, but also for patients living with this disease," stated
John P. Butler, Chief Executive
Officer of Akebia. "The Akebia team and our collaborator, Otsuka,
did an outstanding job preparing this comprehensive submission,
which includes substantial data from over 8,000 patients across 36
clinical trials of vadadustat. We look forward to working with the
FDA during the review process, and are excited to continue
collaborating with our partners to advance vadadustat for the
benefit of patients, subject to regulatory approval."
Based on standard FDA review timelines, the FDA has a 60-day
period to determine whether the NDA is complete and acceptable for
review. The Company's NDA submission did not include a Priority
Review Voucher.
Otsuka Pharmaceutical Co. Ltd. (Otsuka) is working in close
collaboration with Akebia to prepare a Marketing Authorization
Application (MAA) for vadadustat for submission to the European
Medicines Agency (EMA), expected this year.
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 (HIF-PH)
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 recently completed
its global Phase 3 clinical development program for the treatment
of anemia due to CKD. Vadadustat is not approved by the U.S. Food
and Drug Administration (FDA) or any regulatory authority with the
exception of Japan's Ministry of
Health, Labour and Welfare (MHLW). In Japan, vadadustat is approved and marketed
under the tradename Vafseoâ„¢, as a treatment for anemia due to CKD
in both dialysis-dependent and non-dialysis dependent adult
patients.
About Anemia due to Chronic Kidney Disease
(CKD)
Anemia is a condition in which a person lacks enough healthy red
blood cells to carry adequate oxygen to the body's tissues. It
commonly occurs in people with CKD because their kidneys do not
produce enough erythropoietin (EPO), a hormone that helps regulate
production of red blood cells. Anemia due to CKD can have a
profound impact on a person's quality of life as it can cause
fatigue, dizziness, shortness of breath and cognitive dysfunction.
Left untreated, anemia leads to deterioration in health and is
associated with increased morbidity and mortality in people with
CKD.
Forward-Looking Statements
Statements in this
press release regarding 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, including, but not
limited to, statements regarding: the potential for obtaining
approval of vadadustat for the treatment of anemia due to CKD in
both adult patients on dialysis and not on dialysis; the impact of
the vadadustat NDA submission on Akebia, its partners and patients
living with anemia due to CKD; the exact timing of the FDA's
confirmation as to whether the NDA is complete and acceptable for
review; and the timing of submission of an MAA for vadadustat to
the EMA. The terms "expect," "continue," "look forward," "will,"
and similar references are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Each forward-looking statement is subject
to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such
statement, including, but not limited to: any delays in
acceptance and review of the NDA submission by the FDA
for any reason, including the COVID-19 pandemic; the timing of
regulatory filings, including the timing of filing the vadadustat
MAA with the EMA; the direct or indirect impact of the COVID-19
pandemic on regulators and on Akebia's business, operations, and
the markets and communities in which Akebia and its partners,
collaborators, vendors and customers operate; the potential
therapeutic benefits, safety profile and effectiveness of
vadadustat; the timing and content of advice given and decisions
made by regulators, including the FDA and EMA; the potential
indications, demand and market potential and acceptance of
vadadustat; manufacturing, supply and quality risks; risks
associated with hiring, training, management and retention and key
personnel changes and transitional periods; the actual funding
required to develop and commercialize vadadustat, and to operate
Akebia; early termination of any of Akebia's collaborations;
Akebia's and its collaborators' ability to satisfy their
obligations under Akebia's collaboration agreements; the
competitive landscape for vadadustat, if approved; the scope,
timing, and outcome of any legal, regulatory and administrative
proceedings; changes in the economic and financial conditions of
the businesses of Akebia and its collaborations partners and
vendors; expected reliance on third parties, including with respect
to the development, manufacturing, supply or commercialization of
vadadustat, particularly if approved; Akebia's expectations,
projections and estimates regarding its capital requirements; and
Akebia's intellectual property position, including its ability to
obtain, maintain and enforce patent and other intellectual property
protection for vadadustat. Other risks and uncertainties include
those identified under the heading "Risk Factors" in Akebia's
Annual Report on Form 10-K for the year ended December 31, 2020 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.
Investor Contact:
Kristen K. Sheppard, Esq.
ir@akebia.com
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SOURCE Akebia Therapeutics, Inc.