CAMBRIDGE, Mass., June 29,
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 topline results from IMPACT, a Phase 4 collaborative
study investigating the impact of Auryxia® (ferric citrate), when
used as the primary phosphate-lowering therapy, on the utilization
of erythropoiesis-stimulating agent (ESA) and intravenous (IV) iron
as well as on laboratory parameters indicative of phosphate and
anemia management compared to the standard of care (SOC) in adult
patients with chronic kidney disease (CKD) on dialysis. Auryxia is
approved for the control of serum phosphorus levels in adult
patients with chronic kidney disease on dialysis and for the
treatment of iron deficiency anemia in adult patients with chronic
kidney disease not on dialysis.
![Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.) Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)](https://mma.prnewswire.com/media/1136400/Akebia_Logo.jpg)
IMPACT, sponsored by U.S. Renal Care Kidney Research in
collaboration with Akebia, was a randomized, open-label,
active-controlled, multicenter study in adult patients with CKD
receiving either in-center hemodialysis or home dialysis. The study
enrolled 209 adult patients who were randomized 1:1 to Auryxia
(starting dose of 6 tablets per day) or to remain on SOC, defined
as non-Auryxia phosphate-lowering agent, for up to 6 months. The
two groups had generally similar baseline characteristics with the
exception of atherosclerotic cardiovascular disease and congestive
heart failure, which were more common in the SOC group.
Co-primary endpoints were the difference in mean change from
baseline (month -3 to Day 1) to the efficacy evaluation period
(months 4-6) in monthly ESA and IV iron doses between groups.
Secondary endpoints were the difference in the proportion of
patients with serum phosphate ≤5.5 mg/dL and hemoglobin (Hb) ≥10.0
g/dL, during the efficacy evaluation period (months 4-6). Treatment
with Auryxia resulted in a statistically significant difference in
mean monthly ESA use (-30.82 mcg/month, P=0.02) and a
non-significant difference in mean monthly IV iron use (-37.02
mg/month, P=0.17). There were similar proportions of
patients in each group with Hb ≥10.0 g/dL and serum phosphate ≤5.5
mg/dL.
Three patients stopped Auryxia due to gastrointestinal
intolerance (n=2) or adverse events (n=1). Serious adverse events
occurred in 39% of patients receiving Auryxia and 59% in those
receiving SOC.
"Results from the IMPACT study provide valuable insights into
the potential impact of Auryxia in adult patients with
hyperphosphatemia on dialysis. These observations are important for
nephrologists who are evaluating the appropriateness of Auryxia as
a phosphate-lowering agent in this patient population," said
Geoffrey Block, MD., Associate Chief
Medical Officer and SVP, Clinical Research and Medical Affairs,
U.S. Renal Care.
Dr. Block plans to present the full study results at an upcoming
scientific meeting.
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. Akebia 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 U.S. Renal Care
U.S. Renal Care partners with nephrologists to care for
approximately 27,000 people living with kidney disease nationwide.
For over two decades, U.S. Renal Care has been a leader in clinical
quality, innovation, and operational excellence – delivering the
best experience and outcomes for our patients. U.S. Renal Care
operates over 400 in-center and home dialysis programs across 33
states in the U.S. For more information, please visit
usrenalcare.com.
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: statements about the potential impact of Auryxia in
adult patients with hyperphosphatemia on dialysis. 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, Akebia's products; 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 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 Auryxia® are
registered trademarks of Akebia Therapeutics, Inc. and its
affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
Mcarrasco@akebia.com
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