Akebia Therapeutics and U.S. Renal Care Sign Commercial Supply Contract to Enable Access to Vafseo® (vadadustat) for Patients on Dialysis

Rhea-AI Summary

Akebia Therapeutics (Nasdaq: AKBA) and U.S. Renal Care (USRC) have signed a multi-year commercial supply contract for Vafseo® (vadadustat), a treatment for anemia due to chronic kidney disease in adults on dialysis. The agreement covers all USRC dialysis centers, allowing USRC physicians to prescribe Vafseo when it becomes available in January 2025.

Vafseo was approved by the FDA in March 2024 for patients who have been on dialysis for at least three months. Akebia expects to receive Transitional Drug Add-on Payment Adjustment designation for Vafseo in January 2025. This partnership is expected to provide nearly 2000 nephrologists access to prescribe Vafseo for their patients, as clinically appropriate.

Positive

• Multi-year commercial supply contract signed with U.S. Renal Care, a leading dialysis provider
• Vafseo approved by FDA for anemia treatment in dialysis patients
• Expected Transitional Drug Add-on Payment Adjustment designation in January 2025
• Potential access to nearly 2000 nephrologists for Vafseo prescriptions

Negative

• None.

10/07/2024 - 08:00 AM

U.S. Renal Care is a leading provider of in-center and home dialysis in the United States

CAMBRIDGE, Mass., Oct. 7, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, and U.S. Renal Care (USRC), the nation's fastest-growing dialysis provider, today announced entry into a multi-year commercial supply contract encompassing all USRC dialysis centers. The contract enables USRC attending physicians to prescribe Vafseo® for patients on dialysis as deemed clinically appropriate when it is expected to be available in January 2025.

In March 2024, Vafseo was approved by the U.S. Food and Drug Administration for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Akebia expects to receive Transitional Drug Add-on Payment Adjustment designation for Vafseo in January 2025.

"We are excited to deliver a new choice in anemia management for dialysis patients and are extremely pleased to have entered into this supply agreement with U.S. Renal Care," said John P. Butler, Chief Executive Officer of Akebia. "We see USRC at the forefront of innovative care for patients on dialysis and we are pleased that they recognize Vafseo as an important option to make available for their patients. We believe that commitment to innovation will allow nearly 2000 nephrologists access to prescribe Vafseo for patients living with kidney disease, as clinically appropriate."

"U.S. Renal Care is pleased to partner with Akebia to make Vafseo accessible to our patients," said Mark Caputo, Chief Executive Officer, U.S. Renal Care. "Our Office of the Chief Medical Officer and teams of medical professionals are actively working on a protocol for Vafseo, and we believe nephrologists are eager to gain experience with an oral treatment that has the potential to advance the treatment of anemia due to CKD in dialysis patients."

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, the fastest-growing dialysis provider in the nation, partners with nephrologists to care for more than 36,000 people living with kidney disease across 32 states in the U.S. Since 2000, U.S. Renal Care has been a leader in clinical quality, innovation, and operational excellence – delivering the best experience and outcomes for its patients.  Visit USRenalCare.com to learn more. 

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 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.
  
  
• Hypertension
  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
  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.
  
  
• Malignancy
  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 as to the timing of the availability of Vafseo and the receipt and timing of Transitional Drug Add-on Payment Adjustment designation for Vafseo; Akebia's belief that USRC's commitment to innovation will allow nearly 2000 nephrologists access to prescribe Vafseo for patients living with kidney disease, as clinically appropriate; and beliefs that nephrologists are eager to gain experience with an oral treatment and that Vafseo has the potential to advance the treatment of anemia due to CKD in dialysis patients. 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; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia® and Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, 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; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; 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; 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, 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. and its affiliates.

Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com

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SOURCE Akebia Therapeutics, Inc.

FAQ

When will Vafseo (vadadustat) be available for AKBA's dialysis patients?

Vafseo is expected to be available for U.S. Renal Care dialysis patients in January 2025.

What is the FDA approval status of Vafseo (vadadustat) for AKBA?

Vafseo was approved by the FDA in March 2024 for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.

How many nephrologists will potentially have access to prescribe Vafseo (vadadustat) for AKBA?

The partnership between Akebia Therapeutics and U.S. Renal Care is expected to allow nearly 2000 nephrologists access to prescribe Vafseo for patients living with kidney disease, as clinically appropriate.

What is the significance of the Transitional Drug Add-on Payment Adjustment designation for AKBA's Vafseo?

Akebia Therapeutics expects to receive Transitional Drug Add-on Payment Adjustment designation for Vafseo in January 2025, which could potentially impact reimbursement and accessibility of the drug.