Outcomes study will assess mortality and
hospitalization in patients treated with Vafseo compared to current
standard of care
CAMBRIDGE, Mass., Dec. 3, 2024
/PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a
biopharmaceutical company with the purpose to better the lives of
people impacted by kidney disease, announced that in late November
U.S. Renal Care (USRC) enrolled the first patient in its Vafseo®
(vadadustat) Outcomes In-Center Experience (VOICE)
collaborative trial. Akebia announced the collaborative trial
initiation in September
2024.
"We look forward to begin treating CKD anemia patients on
dialysis with Vafseo ahead of its anticipated market launch in
January 2025," said Steven K. Burke, M.D., Chief Medical Officer of
Akebia. "The study has been designed to evaluate Vafseo safety and
efficacy when dosed three times a week to align with patients'
current dialysis schedule as well as to explore additional
potential patient benefits. We congratulate Dr. Geoff Block and his team at USRC on quickly
consenting patients for the study and thank him for his commitment
to patients impacted by kidney disease."
Vafseo was approved by the U.S. Food and Drug Administration in
March 2024 for the treatment of
anemia due to chronic kidney disease (CKD) in adults who have been
receiving dialysis for at least three months. Vafseo is approved
for once-daily oral administration and is expected to be available
in the U.S. in January 2025.
The VOICE trial intends to enroll approximately 2,200 patients
who will be randomized to oral Vafseo 300 mg tablets administered
three times per week or standard-of-care erythropoiesis-stimulating
agents. The trial will end approximately 18 months after the last
patient is randomized. The primary endpoint is non-inferiority for
all-cause mortality and the secondary endpoint will test
superiority of Vafseo to reduce all-cause hospitalization. More
information about the VOICE trial can be found here.
About U.S. Renal Care
U.S. Renal Care partners with nephrologists across 32 states in
the U.S. to care for more than 36,000 people living with kidney
disease. Since 2000, U.S. Renal Care has been a leader in clinical
quality, innovation, and operational excellence – delivering the
best experience and outcomes for our patients. For more
information, visit USRenalCare.com.
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 Vafseo® (vadadustat) tablets
Vafseo® (vadadustat) tablets is a once-daily oral
hypoxia-inducible factor prolyl hydroxylase inhibitor that
activates the physiologic response to hypoxia to stimulate
endogenous production of erythropoietin, increasing hemoglobin and
red blood cell production to manage anemia. Vafseo is approved for
use in 37 countries.
INDICATION
VAFSEO is indicated for the treatment of anemia due to chronic
kidney disease (CKD) in adults who have been receiving dialysis for
at least three months.
Limitations of Use
- VAFSEO has not been shown to improve quality of life, fatigue,
or patient well-being.
- VAFSEO is not indicated for use:
- As a substitute for red blood cell transfusions in patients who
require immediate correction of anemia.
- In patients with anemia due to CKD not on dialysis.
IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat)
tablets
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL
INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF
VASCULAR ACCESS.
VAFSEO increases the risk of thrombotic vascular events,
including major adverse cardiovascular events (MACE).
Targeting a hemoglobin level greater than 11 g/dL is expected
to further increase the risk of death and arterial and venous
thrombotic events, as occurs with erythropoietin stimulating agents
(ESAs), which also increase erythropoietin levels.
No trial has identified a hemoglobin target level, dose of
VAFSEO, or dosing strategy that does not increase these
risks.
Use the lowest dose of VAFSEO sufficient to reduce the need
for red blood cell transfusions.
CONTRAINDICATIONS
- Known hypersensitivity to VAFSEO or any of its components
- Uncontrolled hypertension
WARNINGS AND PRECAUTIONS
- Increased Risk of Death, Myocardial Infarction (MI), Stroke,
Venous Thromboembolism, and Thrombosis of Vascular
Access
A rise in hemoglobin (Hb) levels greater than 1
g/dL over 2 weeks can increase these risks. Avoid in patients with
a history of MI, cerebrovascular event, or acute coronary syndrome
within the 3 months prior to starting VAFSEO. Targeting a Hb level
of greater than 11 g/dL is expected to further increase the risk of
death and arterial and venous thrombotic events. Use the lowest
effective dose to reduce the need for red blood cell (RBC)
transfusions. Adhere to dosing and Hb monitoring recommendations to
avoid excessive erythropoiesis.
Hepatocellular injury attributed to VAFSEO was
reported in less than 1% of patients, including one severe case
with jaundice. Elevated serum ALT, AST, and bilirubin levels were
observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with
VAFSEO, respectively. Measure ALT, AST, and bilirubin before
treatment and monthly for the first 6 months, then as clinically
indicated. Discontinue VAFSEO if ALT or AST is persistently
elevated or accompanied by elevated bilirubin. Not recommended in
patients with cirrhosis or active, acute liver disease.
Worsening of hypertension was reported in 14% of
VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of
hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin
alfa patients. Cases of hypertensive crisis, including hypertensive
encephalopathy and seizures, have also been reported in patients
receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive
therapy as needed.
Seizures occurred in 1.6% of VAFSEO and 1.6% of
darbepoetin alfa patients. Monitor for new-onset seizures,
premonitory symptoms, or change in seizure frequency.
- Gastrointestinal (GI) Erosion
Gastric or esophageal erosions occurred in 6.4%
of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI
erosions, including GI bleeding and the need for RBC transfusions,
were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa
patients. Consider this risk in patients at increased risk of GI
erosion. Advise patients about signs of erosions and GI bleeding
and urge them to seek prompt medical care if present.
- Serious Adverse Reactions in Patients with Anemia Due
to CKD and Not on Dialysis
The safety of VAFSEO has not been established
for the treatment of anemia due to CKD in adults not on dialysis
and its use is not recommended in this setting. In large clinical
trials in adults with anemia of CKD who were not on dialysis, an
increased risk of mortality, stroke, MI, serious acute kidney
injury, serious hepatic injury, and serious GI erosions was
observed in patients treated with VAFSEO compared to darbepoetin
alfa.
VAFSEO has not been studied and is not
recommended in patients with active malignancies. Malignancies were
observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients.
No evidence of increased carcinogenicity was observed in animal
studies.
ADVERSE REACTIONS
- The most common adverse reactions (occurring at ≥ 10%) were
hypertension and diarrhea.
DRUG INTERACTIONS
- Iron supplements and iron-containing phosphate binders:
Administer VAFSEO at least 1 hour before products containing
iron.
- Non-iron-containing phosphate binders: Administer VAFSEO
at least 1 hour before or 2 hours after non-iron-containing
phosphate binders.
- BCRP substrates: Monitor for signs of substrate adverse
reactions and consider dose reduction.
- Statins: Monitor for statin-related adverse reactions.
Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5
mg.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Lactation: Breastfeeding not recommended until two days after
the final dose.
- Hepatic Impairment: Not recommended in patients with
cirrhosis or active, acute liver disease.
Please note that this information is not comprehensive.
Please click here for the Full Prescribing
Information, including BOXED WARNING and Medication Guide.
Forward-Looking Statements
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 VOICE trial, including expectations as
to the potential benefits and risks of Vafseo when dosed three
times a week in dialysis patients, and Akebia's expectations as to
the timing of the market availability of Vafseo in the U.S.
The terms "intend," "believe," "plan," "goal," "potential,"
"anticipate, "estimate," "expect," "future," "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: whether Vafseo will be
commercially available when expected; manufacturing, supply chain
and quality matters and any recalls, write-downs, impairments or
other related consequences or potential consequences; the results
of preclinical and clinical research; the potential therapeutic
benefits, safety profile, and effectiveness of Vafseo; the
potential demand and market potential and acceptance of, as well as
coverage and reimbursement related to Vafseo; the competitive
landscape for Vafseo; the ability of Akebia to attract and retain
qualified personnel; 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 the markets and communities in
which Akebia and its partners, collaborators, vendors and customers
operate; 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 September 30, 2024, 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
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SOURCE Akebia Therapeutics, Inc.
