CAMBRIDGE, Mass., May 22, 2023
/PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq:
AKBA) today announced that the United
Kingdom (UK) Medicines and Healthcare products Regulatory
Agency (MHRA) has granted marketing authorization for
Vafseo® (vadadustat), an oral hypoxia-inducible factor
prolyl hydroxylase (HIF-PH) inhibitor for the treatment of
symptomatic anemia associated with chronic kidney disease (CKD) in
adults on chronic maintenance dialysis.
"With the UK MHRA marketing authorization for Vafseo, we're
pleased to add another approval in Europe," said John P.
Butler, Chief Executive Officer of Akebia. "Again, I want to
recognize our team, and the patients, physicians, investigators,
and site coordinators who participated in our global trial and made
this approval possible. We look forward to completing a partnership
in Europe and bringing an
additional therapeutic option to patients on dialysis in the
United Kingdom."
Anemia due to CKD, common among patients on dialysis, is often
associated with adverse clinical outcomes. The MHRA approval of
Vafseo is based 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.
IMPORTANT SAFETY INFORMATION
The full
Summary of Product Characteristics (SPC/SmPC) for
Vafseo® (vadadustat) will be available on the UK MHRA
website at https://products.mhra.gov.uk/.
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). 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 plans with respect to commercializing and
completing a partnership 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, 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 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