Akebia Received Type A Meeting Minutes from
the FDA
CAMBRIDGE, Mass., Aug. 24,
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 that the company expects to
resubmit its New Drug Application (NDA) for vadadustat as a
treatment for anemia due to chronic kidney disease in adult
patients on dialysis by the end of the third quarter of 2023. Upon
acceptance of the NDA, Akebia expects the U.S. Food and Drug
Administration (FDA) to set a PDUFA date of six months from the
date of submission.
Akebia received Meeting Minutes summarizing the productive and
informative discussion held during an End of Dispute Type A meeting
with the FDA in July 2023. The
minutes reflect Akebia's plan for the NDA resubmission discussed at
the meeting.
Vadadustat is currently approved for use in 34 countries.
Vafseo® (vadadustat) is marketed in Japan by Mitsubishi Tanabe Pharma
Corporation.
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 (FDA). Vadadustat is approved in Europe for the treatment of symptomatic anemia
due to CKD in adult patients on chronic maintenance dialysis. In
Japan, vadadustat is approved 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
expectations and plans with respect to the resubmission of its NDA
for vadadustat, including the timing thereof and information to be
included therein; and Akebia's expectations regarding the timing
for a decision by the FDA on its NDA for vadadustat once
resubmitted. The terms "intend," "believe," "plan," "goal,"
"expect," "potential," "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 the FDA
with respect to Akebia's resubmission of its NDA for
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; decisions made by
health authorities, such as the FDA, with respect to regulatory
filings, including the anticipated resubmission of the New Drug
Application for vadadustat; the potential therapeutic benefits,
safety profile, and effectiveness of vadadustat; 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 March 31, 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® and Vafseo® are
registered trademarks of Akebia Therapeutics, Inc.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics