U.S. Renal Care Enrolled First Patients in the VOICE Collaborative Clinical Trial of Vafseo® (vadadustat) for CKD Patients on Dialysis
Rhea-AI Summary
Akebia Therapeutics (Nasdaq: AKBA) announced that U.S. Renal Care has enrolled the first patients in the VOICE collaborative trial for Vafseo (vadadustat). The study will evaluate Vafseo's safety and efficacy when administered three times weekly to dialysis patients, comparing it to standard-of-care treatments. The trial aims to enroll approximately 2,200 patients and will assess non-inferiority for all-cause mortality as primary endpoint and superiority in reducing all-cause hospitalization as secondary endpoint. Vafseo, approved by the FDA in March 2024 for anemia in CKD patients on dialysis, is expected to launch in January 2025.
Positive
- FDA approval received for Vafseo in March 2024
- Commercial launch planned for January 2025
- Large-scale trial with 2,200 patients demonstrates significant investment in product development
Negative
- Product not yet commercially available
- Must prove non-inferiority against existing treatments
- to patients who have been on dialysis for at least three months
News Market Reaction
On the day this news was published, AKBA declined 4.23%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care
"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
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
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
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.
- Hepatotoxicity
Hepatocellular injury attributed to VAFSEO was reported in less than
- Hypertension
Worsening of hypertension was reported in
- Seizures
Seizures occurred in
- Gastrointestinal (GI) Erosion
Gastric or esophageal erosions occurred in
- 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.
- Malignancy
VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in
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.
FAQ
When will Vafseo (AKBA) be available in the US market?
How many patients will be enrolled in the VOICE trial for Vafseo (AKBA)?
What is the primary endpoint of Akebia's (AKBA) VOICE trial for Vafseo?
When did the FDA approve Vafseo (AKBA) for CKD patients?
