CAMBRIDGE, Mass., Dec. 22,
2022 /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 an interim response from the
U.S. Food and Drug Administration (FDA) to its Formal Dispute
Resolution Request regarding the Complete Response Letter received
in March 2022 for vadadustat, which
had been submitted to the FDA as a treatment for anemia due to
chronic kidney disease in adult patients.
Akebia met with the FDA in November to discuss its appeal and
subsequently received a request for additional clarifying
information from the Office of New Drugs, Center for Drug
Evaluation and Research, which is deciding the appeal. Akebia
remains engaged with the FDA and expects to submit the requested
information to the FDA in January
2023. Based on FDA guidance, Akebia expects to receive a
response to its appeal 30 days from the date Akebia submits the
requested information.
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
with respect to when it will submit the information requested by
the U.S. Food and Drug Administration (FDA) to the FDA in
January 2023 and 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, with respect to Akebia's regulatory
filings, including the New Drug Application and the Formal Dispute
Resolution Request for vadadustat; the perceived therapeutic
benefits, safety profile, and effectiveness of vadadustat; and 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. 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