CAMBRIDGE, Mass., July 18,
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 Akebia completed an End of Dispute Type A meeting
with the U.S. Food and Drug Administration (FDA) to discuss
Akebia's forthcoming resubmission of its New Drug Application (NDA)
for vadadustat as a treatment for anemia due to chronic kidney
disease (CKD) in adult patients on dialysis.
"We're pleased to report we recently met with the FDA to align
on the content of our NDA resubmission for vadadustat," said
John P. Butler, Chief Executive
Officer of Akebia. "The meeting was informative and productive,
and we're eager to advance the U.S. regulatory process and
potentially bring a new oral treatment to dialysis patients with
anemia due to CKD."
Akebia expects to receive the FDA's meeting minutes by
mid-August and plans to resubmit its NDA for vadadustat by the end
of the third quarter of 2023. Upon acceptance of the NDA, Akebia
expects the FDA to set a PDUFA date of six months from the date of
submission.
Vadadustat is currently approved for use in 34 countries, it was
most recently approved by the Swiss Agency for Therapeutic Products
(Swissmedic) in June 2023.
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.
Important Safety Information
For safety information,
view the European Summary of Product Characteristics (SPC/SmPC) for
Vafseo® (vadadustat) at
https://ec.europa.eu/health/documents/community-register/2023/20230424158854/anx_158854_en.pdf,
https://products.mhra.gov.uk/, and will be available via
SwissMedic here.
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 data to be included
therein; Akebia's expectations regarding the timing for a decision
by the FDA on its NDA for vadadustat once resubmitted and
statements regarding the potential to bring vadadustat to dialysis
patients with anemia due to CKD. The terms "expect," "intend,"
"believe," "plan," "goal," "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, vadadustat; the
results of preclinical and clinical research; the potential
therapeutic benefits, safety profile, and effectiveness of
vadadustat; 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 the competitive
landscape for vadadustat, if approved. 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