CAMBRIDGE, Mass., Aug. 26, 2020 /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 vadadustat, its oral
hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is
now commercially available in Japan as a treatment for anemia due to chronic
kidney disease (CKD) under the trade name VAFSEO™.
VAFSEO has been included in the Japan National Health Insurance
drug price listing and was granted regulatory approval as a
treatment for anemia due to CKD in both dialysis-dependent and
non-dialysis dependent adult patients by the Ministry of Health,
Labour and Welfare in Japan in
June 2020. The starting dose for
VAFSEO is indicated at 300 mg with a maximum dose indicated at 600
mg.
VAFSEO provides adult patients in Japan with a once-daily treatment option and
has the potential to set a new oral standard of care for the
treatment of renal anemia in Japan. An estimated 13 million people in
Japan have advanced stages of CKD.
Anemia is common in patients with CKD, and its prevalence increases
as CKD progresses. Anemia due to CKD can result in serious
complications including irregular or unusually fast heartbeat,
enlargement of the heart, and heart failure and also has
well-documented impacts on quality of life. Injectable
erythropoiesis-stimulating agents (ESAs) are currently the standard
of care.
In 2015, Akebia and Mitsubishi Tanabe Pharma Corporation (MTPC)
entered into a collaboration agreement that provided MTPC with
exclusive rights to develop and commercialize vadadustat in
Japan and certain other Asian
countries. Under the terms of the agreement, Akebia is eligible to
receive up to approximately $190
million in future milestone payments from MTPC, based upon
achievement of certain regulatory and sales milestones. MTPC is
also obligated to make tiered double-digit royalty payments to
Akebia of up to 20% on sales of vadadustat in Japan and certain other Asian countries,
subject to regulatory approval.
Vadadustat is in global Phase 3 development for the treatment of
anemia due to CKD and is not yet approved outside of Japan.
About Vadadustat
Vadadustat is an oral
hypoxia-inducible factor prolyl hydroxylase (HIF-PH) 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 in global Phase 3
development for the treatment of anemia due to CKD and is not
approved by the U.S. Food and Drug Administration (FDA) or any
regulatory authority with the exception of Japan's Ministry of Health, Labour and Welfare
(MHLW). In Japan, vadadustat is
approved as a treatment for anemia due to CKD in both
dialysis-dependent and non-dialysis dependent adult patients.
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.
Forward-Looking Statements
Statements in this press
release regarding 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, including but not
limited to statements regarding the commercialization of VAFSEO in
Japan, prevalence of CKD, and
related milestone and royalty payments. The terms "believe,"
"expect" and similar references are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Each forward-looking
statement is subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
in such statement, including the potential direct or indirect
impact of the COVID-19 pandemic on our and our partners',
collaborators', vendors' and customers' businesses, operations, and
the markets and communities in which we and our partners,
collaborators, vendors and customers operate; manufacturing risks;
risks associated with management and key personnel changes and
transitional periods; market acceptance and coverage and
reimbursement of VAFSEO in Japan;
the risks associated with potential generic entrants; early
termination of any of Akebia's collaborations and material
contracts; Akebia's and its collaborators' ability to satisfy their
obligations under Akebia's collaboration agreements and material
contracts; the timing and content of decisions made by regulatory
authorities; the competitive landscape; the scope, timing, and
outcome of any legal, regulatory and administrative proceedings;
changes in the economic and financial conditions of the businesses
of Akebia and its partners; and Akebia's and its partners' ability
to obtain, maintain and enforce patent and other intellectual
property protection. 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 June 30, 2020 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 Akebia
does not undertake, and specifically disclaims, any obligation to
update any forward-looking statements contained in this press
release.
Akebia Therapeutics
Kristen K.
Sheppard, Esq.
ir@akebia.com
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SOURCE Akebia Therapeutics