CAMBRIDGE, Mass., Feb. 23,
2023 /PRNewswire/ -- Akebia Therapeutics®,
Inc. (NASDAQ: AKBA) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion recommending the
European Commission (EC) to approve Vafseo™ (vadadustat), an oral
hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for
the treatment of symptomatic anaemia associated with chronic kidney
disease (CKD) in adults on chronic maintenance dialysis. The EC
will review the CHMP recommendation and deliver a final decision in
approximately two months. The decision will be applicable to all 27
European Union member states plus Iceland, Norway and Liechtenstein.
"We are extremely pleased by the CHMP's positive opinion for our
marketing authorisation application for Vafseo for patients on
dialysis," said John P. Butler,
Chief Executive Officer of Akebia. "We are driven to better the
lives of people impacted by chronic kidney disease and a positive
opinion is a critical step toward delivering on this purpose. We
believe more treatment options are needed for patients with anaemia
on dialysis, and if we receive a positive EC decision Vafseo could
offer an oral treatment to help address this need. This is also an
important milestone in our process to identify and secure a
potential partner in Europe to
bring Vafseo to those patients."
The CHMP based its positive opinion on data from a comprehensive
development program that included over 7,500 patients, including
the global Phase 3 clinical program of vadadustat for the treatment
of anemia due to CKD in adult patients on dialysis
(INNO2VATE).
In the study of adult patients on dialysis, vadadustat achieved
the primary and key secondary efficacy endpoint in each of the two
INNO2VATE studies, demonstrating non-inferiority to
darbepoetin alfa as measured by a mean change in hemoglobin (Hb)
between baseline and the primary evaluation period (weeks 24 to 36)
and secondary evaluation period (weeks 40 to 52). Vadadustat also
achieved the primary safety endpoint of the INNO2VATE
program, defined as non-inferiority of vadadustat versus
darbepoetin alfa in time to first occurrence of major adverse
cardiovascular events, which is the composite of all-cause
mortality, non-fatal myocardial infarction, or non-fatal stroke
across both INNO2VATE studies.
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). 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 decision from the European
Commission and, if approved, Akebia's plans with respect to
commercializing and identifying a partner for Vafseo in
Europe. 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; 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® and Vafseo™ (vadadustat) are registered
trademarks or trademarks of Akebia Therapeutics, Inc.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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