Akebia Therapeutics Signs Commercial Supply Contract with Leading Dialysis Organization to Enable Access to Vafseo® (vadadustat) for Patients on Dialysis

Rhea-AI Summary

Akebia Therapeutics (Nasdaq: AKBA) has signed a multi-year commercial contract with a leading kidney care provider to expand access to Vafseo® (vadadustat) for patients on dialysis. This agreement allows physicians to prescribe Vafseo to dialysis patients as clinically appropriate, with availability expected in January 2025.

The contract is with a comprehensive kidney care provider serving over 200,000 patients at thousands of U.S. dialysis centers. Vafseo, approved by the FDA in March 2024 for treating anemia due to chronic kidney disease in adults on dialysis for at least three months, received Transitional Drug Add-On Payment Adjustment reimbursement from CMS starting January 1, 2025.

Akebia's Chief Commercial Officer, Nik Grund, emphasized that expanding access to Vafseo is a priority for their commercial launch, aiming to provide a new option in anemia management for dialysis patients.

Positive

• Multi-year commercial contract signed with a major kidney care provider
• Expanded access to Vafseo for over 200,000 patients across thousands of U.S. dialysis centers
• FDA approval received for Vafseo in March 2024
• CMS granted Transitional Drug Add-On Payment Adjustment reimbursement for Vafseo
• Level II Healthcare Common Procedure Coding System code issued for Medicare billing

Negative

• Vafseo will not be available until January 2025

Insights

Pharmaceutical Industry Analyst

This commercial supply contract with a major dialysis provider marks a significant milestone for Akebia Therapeutics and its product Vafseo. The agreement potentially opens up access to over 200,000 dialysis patients, representing a substantial market opportunity. The timing is strategic, aligning with Vafseo's expected U.S. availability in January 2025. The recent FDA approval for Vafseo in March 2024 and the CMS granting of Transitional Drug Add-On Payment Adjustment reimbursement are important factors that will likely facilitate adoption. This contract positions Akebia favorably in the competitive landscape of anemia management in chronic kidney disease. However, actual revenue impact will depend on physician adoption rates and patient uptake, which remain to be seen. Investors should monitor early prescription trends and any subsequent contracts with other dialysis providers to gauge the product's market penetration and potential financial impact on Akebia.

Healthcare Policy Expert

The approval of Vafseo by the FDA for anemia treatment in dialysis patients, coupled with the CMS granting Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement, signifies a supportive regulatory environment for this new therapy. The TDAPA designation is particularly important as it provides additional Medicare reimbursement for new drugs in the dialysis setting, potentially accelerating adoption. The issuance of a Level II HCPCS code further streamlines the billing process for dialysis centers, reducing administrative barriers to use. This alignment of regulatory approval, reimbursement support and simplified billing demonstrates a favorable policy landscape for Vafseo's market entry. The contract with a major dialysis provider suggests that Akebia has successfully navigated the complex healthcare policy environment to secure market access. This could serve as a model for future agreements and may influence broader policy discussions on innovative treatments in the dialysis sector.

Contract in place with a comprehensive kidney care provider serving more than 200,000 patients at its thousands of U.S. dialysis centers 

CAMBRIDGE, Mass., Oct. 22, 2024 /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 has signed a multi-year commercial contract with one of the nation's leading providers of kidney care services, expanding access to Vafseo® (vadadustat) for patients on dialysis. The contract enables physicians to prescribe Vafseo to patients on dialysis as deemed clinically appropriate. Akebia expects Vafseo will be available in the U.S. in January 2025.

In March 2024, the U.S. Food and Drug Administration approved Vafseo for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. In October 2024 the Center for Medicare & Medicaid Services granted Transitional Drug Add-On Payment Adjustment reimbursement for Vafseo starting on January 1, 2025, and issued a Level II Healthcare Common Procedure Coding System code, which will be used for billing for the product by dialysis organizations for Medicare enrollees.

"Expanding access to Vafseo is a priority of our commercial launch as we work to deliver a new choice in anemia management to patients on dialysis," said Nik Grund, Chief Commercial Officer, Akebia. "We believe a supply agreement with one of the largest dialysis organizations in the country will significantly broaden access to Vafseo among its physicians and for its more than 200,000 patients at dialysis centers across the U.S."

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.
• 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; Akebia's plans with respect to its commercial launch of Vafseo, including Akebia's ability to deliver a new choice in anemia management to patients on dialysis; and Akebia's belief that a supply agreement with one of the largest dialysis organizations in the country will significantly broaden access to Vafseo among its physicians and for its more than 200,000 patients at dialysis centers across the U.S. and enable those physicians to prescribe Vafseo. 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/akebia-therapeutics-signs-commercial-supply-contract-with-leading-dialysis-organization-to-enable-access-to-vafseo-vadadustat-for-patients-on-dialysis-302282426.html

SOURCE Akebia Therapeutics, Inc.

FAQ

When will Vafseo (vadadustat) be available for patients on dialysis in the US?

Akebia Therapeutics expects Vafseo to be available in the U.S. in January 2025.

What is the purpose of Akebia Therapeutics' (AKBA) new commercial contract?

The contract aims to expand access to Vafseo (vadadustat) for patients on dialysis, enabling physicians to prescribe it as clinically appropriate.

When did the FDA approve Vafseo (vadadustat) for anemia treatment in dialysis patients?

The U.S. Food and Drug Administration approved Vafseo 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.

What reimbursement has Vafseo (vadadustat) received from CMS for AKBA?

In October 2024, the Center for Medicare & Medicaid Services granted Transitional Drug Add-On Payment Adjustment reimbursement for Vafseo starting on January 1, 2025.