CAMBRIDGE, Mass., Sept. 26,
2023 /PRNewswire/ -- Akebia Therapeutics®,
Inc. (Nasdaq: AKBA) today announced that Australia's Therapeutic Goods Administration
(TGA) has granted approval for Vafseo® (vadadustat), an
oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the
treatment of anemia associated with chronic kidney disease (CKD) in
adults on chronic maintenance dialysis.
The TGA approval for 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).
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.
"The Akebia team continues to execute on our plan to make Vafseo
available to patients globally," said John
Butler, Chief Executive Officer of Akebia. "With
authorization in Australia, the
product is now approved in 35 countries. We also expect to resubmit
our new drug application for vadadustat in the U.S. by the end of
this quarter."
To support the global launch of Vafseo and prepare for a
potential launch in the U.S., Akebia also announced an addition to
its commercial team. Akebia appointed Graham Ray as Vice President, Key Accounts,
reporting to Bennett Smith, Senior
Vice President, Commercial, to lead customer engagement. Mr. Ray
has a track record of successful product launches, brand growth and
sales operations efficiencies, expertise he gained over nearly 20
years at Takeda Pharmaceuticals. Mr. Ray will be responsible for
leading the sales efforts to launch vadadustat in the U.S., if
approved, as well as work to maximize the value of Auryxia® (ferric
citrate).
Akebia slightly lowered Auryxia net product revenue guidance to
$170-$175
million for 2023 from $175-$180 million
due to an unfavorable impact from market dynamics, volume and payor
mix.
Mr. Butler continued, "I'm very pleased to have Graham join the
team as he shares our commitment to patients, a core value that is
integral to successful customer engagement. I believe Graham can
enable the company to maximize the value of Auryxia both in the
time before loss of exclusivity and during the expected TDAPA
period for phosphate binders. I also look forward to his
contributions to the potential launch of vadadustat next year."
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 not approved by the U.S. Food and Drug
Administration. 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.
IMPORTANT SAFETY INFORMATION
For safety
information, view the European Summary of Product Characteristics
(SPC/SmPC) for Vafseo® (vadadustat) at
https://ec.europa.eu/health/documents/community-register/2023/20230424158854/anx_158854_en.pdf,
https://products.mhra.gov.uk/ and
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/swisspar.html
and will be available via the Australian Therapeutic Goods
Administration website here.
INDICATION AND IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA
(ferric citrate)
AURYXIA® (ferric citrate) is indicated for:
- The control of serum phosphorus levels in adult patients with
chronic kidney disease on dialysis
- The treatment of iron deficiency anemia in adult patients with
chronic kidney disease not on dialysis
CONTRAINDICATION
AURYXIA (ferric citrate) is contraindicated in patients with
iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and
transferrin saturation (TSAT) were observed in clinical trials with
AURYXIA in patients with chronic kidney disease (CKD) on dialysis
treated for hyperphosphatemia, which may lead to excessive
elevations in iron stores. Assess iron parameters prior to
initiating AURYXIA and monitor while on therapy. Patients receiving
concomitant intravenous (IV) iron may require a reduction in dose
or discontinuation of IV iron therapy.
- Risk of Overdosage in Children Due to Accidental
Ingestion: Accidental ingestion and resulting overdose of
iron-containing products is a leading cause of fatal poisoning in
children under 6 years of age. Advise patients of the risks to
children and to keep AURYXIA out of the reach of children.
ADVERSE REACTIONS
Most common adverse reactions with AURYXIA were:
- Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%),
discolored feces (19%), nausea (11%), constipation (8%), vomiting
(7%) and cough (6%).
- Iron Deficiency Anemia in CKD Not on Dialysis:
Discolored feces (22%), diarrhea (21%), constipation (18%), nausea
(10%), abdominal pain (5%) and hyperkalemia (5%).
SPECIFIC POPULATIONS
- Pregnancy and Lactation: There are no available
data on AURYXIA use in pregnant women to inform a drug-associated
risk of major birth defects and miscarriage. However, an overdose
of iron in pregnant women may carry a risk for spontaneous
abortion, gestational diabetes and fetal malformation. Data from
rat studies have shown the transfer of iron into milk, hence, there
is a possibility of infant exposure when AURYXIA is administered to
a nursing woman.
To report suspected adverse reactions, contact Akebia
Therapeutics at 1-844-445-3799.
Please see full Prescribing Information
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 and plans with respect to the resubmission of its new
drug application ("NDA") for vadadustat, including the timing
thereof, plans to make Vafseo available to patients globally,
statements about the potential launch of vadadustat in the U.S.,
and Akebia's revenue guidance for Auryxia in 2023 and assumptions
related thereto, including statements about Akebia's ability to
maximize the value of Auryxia and expectations about a Transitional
Drug Add-on Payment Adjustment ("TDAPA") period for phosphate
binders. The terms "intend," "believe," "plan," "goal," "expect,"
"potential," "anticipate," "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, Auryxia, including estimates regarding
the potential market opportunity; the competitive landscape for
Auryxia, including potential generic entrants; the ability of
Akebia to attract and retain qualified personnel; Akebia's ability
to implement cost avoidance measures and reduce operating expenses;
decisions made by health authorities, such as the FDA, with respect
to regulatory filings, including the anticipated resubmission of
the NDA for vadadustat; the potential therapeutic benefits, safety
profile, and effectiveness of vadadustat; the results of
preclinical and clinical research; 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; and early termination of any of Akebia's
collaborations. 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, 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®, Vafseo® (vadadustat)
and Auryxia® (ferric citrate) are registered
trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics