CAMBRIDGE, Mass., Feb. 21,
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 received a second interim response from
the U.S. Food and Drug Administration to its Formal Dispute
Resolution Request regarding the Complete Response Letter for
vadadustat received in March
2022.
Akebia received notification from the Office of New Drugs (OND),
Center for Drug Evaluation and Research, that due to agency
resource constraints and staffing needs the deciding authority for
the appeal will now be Peter Stein,
M.D., Director, OND. The appeal was originally assigned to a Senior
Advisor within the OND.
Dr. Stein has indicated a need to seek internal consultation
with nephrology, cardiology and liver safety experts in the Office
of New Drugs to complete the review and render a decision. Dr.
Stein indicated that he will do all he can to facilitate the
appropriate meetings and discussions given the delay resulting from
the staffing change. Akebia expects to be notified of a response to
the appeal within thirty days of Dr. Stein completing the
discussions and any required follow up.
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 an investigational new drug and is not
approved by the U.S. Food and Drug Administration (FDA). On
March 29, 2022, the FDA issued a
complete response letter to Akebia's New Drug Application for
vadadustat for the treatment of anemia due to chronic kidney
disease (CKD). In November 2022,
Akebia submitted a Formal Dispute Resolution Request focused on the
favorable balance of the benefits and risks of vadadustat for the
treatment of anemia due to CKD in adult patients on dialysis.
Vadadustat is currently under review by the European Medicines
Agency for the treatment of anemia due to CKD in adults. 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 on the timing of a response from the FDA with respect
to its appeal. 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 health
authorities, such as the FDA and the European Medicines Agency,
with respect to regulatory filings, including the New Drug
Application for vadadustat and the Formal Dispute Resolution
Request for vadadustat; 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; early termination of any of Akebia's
collaborations; 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 September
30, 2022, 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