CAMBRIDGE, Mass., Oct. 18,
2023 /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 it will present data at the American Society of
Nephrology Kidney Week 2023 (ASN Kidney Week), which will take
place at the Pennsylvania
Convention Center in Philadelphia
from November 2-5, 2023.
Akebia-supported posters will be presented at ASN Kidney Week on
November 2, 2023, from 10:00 a.m. – 12:00 p.m.
EST. Abstracts are available here. ASN Kidney Week attendees
can also visit Akebia at Booth #2515 in the Exhibit
Hall.
Notably, Akebia will present a poster with data on alternate
dosing for vadadustat, its investigational oral hypoxia-inducible
factor prolyl hydroxylase inhibitor, for the treatment of anemia
due to chronic kidney disease in adult patients on dialysis. Akebia
resubmitted a New Drug Application for vadadustat as a daily
treatment to the U.S. Food and Drug Administration in late
September and expects a Prescription Drug User Fee Act (PDUFA) date
to be assigned before the end of October.
Safety and Efficacy of Vadadustat Thrice Weekly in Patients
with Anemia Due to Dialysis-Dependent Chronic Kidney Disease -
Poster Board #: TH-PO983
Randomized Assessment of Auryxia® (ferric citrate)
Therapy for In-Center and Home Dialysis Patients - Poster Board
#: TH-PO967
Hospitalizations and RBC Transfusions in Patients with DD-CKD
on Auryxia® (ferric citrate) Compared to Other Phosphate
Binders - Poster Board #: TH-PO973
Safety and Tolerability of Auryxia® (ferric
citrate) in Children with Hyperphosphatemia Related to Chronic
Kidney Disease - Poster Board #: INFO12-TH
Decision Tree Model Simulating the Burden of
Hyperphosphatemia in U.S. Adult Patients with ESKD on Dialysis
- Poster Board #: TH-PO139
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 35 countries, including
Europe and Australia, for the treatment of symptomatic
anemia due to CKD in adult patients on chronic maintenance dialysis
and in Japan as a treatment for
anemia due to CKD in both dialysis-dependent and
non-dialysis-dependent adult patients.
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 six (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 the 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 regarding the
acceptance by the FDA and a decision by the FDA on its NDA for
vadadustat, including the timing thereof. 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: decisions made by health authorities, such
as the FDA, with respect to regulatory filings, including the
anticipated FDA decision on the NDA for vadadustat; the potential
therapeutic benefits, safety profile, and effectiveness of
vadadustat; 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; 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® and Auryxia® are
registered trademarks of Akebia Therapeutics, Inc.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics