CAMBRIDGE, Mass., June 20,
2023 /PRNewswire/ -- Akebia Therapeutics®,
Inc. (Nasdaq: AKBA) today announced that the Swiss Agency for
Therapeutic Products (Swissmedic) 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 Swissmedic marketing authorization of Vafseo, we're
pleased to note that vadadustat is now approved in 34 countries,"
said John P. Butler, Chief Executive
Officer of Akebia. "We anticipate our partner Medice will launch
Vafseo in Europe this year, and we
are eager to support the launch to bring an additional therapeutic
option to patients on dialysis."
Anemia due to CKD, common among patients on dialysis, is often
associated with adverse clinical outcomes. Throughout Europe, it is estimated that at least 325,000
dialysis patients are currently treated for anemia associated with
CKD.
The Swissmedic 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.
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).
IMPORTANT SAFETY INFORMATION
The prescribing
information for Vafseo® (vadadustat) will
be available on the Swissmedic website
here.
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.
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 and expectations with respect to commercializing Vafseo in
Europe, including the timing
thereof. The terms "expect," "anticipate", "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: the potential demand and
market potential and acceptance of, as well as coverage and
reimbursement related to, vadadustat; 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; 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; 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/akebia-announces-swissmedic-approval-of-vafseo-vadadustat-301854778.html
SOURCE Akebia Therapeutics