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Akebia Therapeutics Reports Milestones for Vafseo and Future Trials

Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical firm dedicated to improving the lives of individuals with kidney disease, has unveiled multiple positive updates regarding its product, Vafseo® (vadadustat). These developments signal a promising future for those affected by chronic kidney disease (CKD).

New Availability of Vafseo

As of January 2025, Vafseo tablets are now widely available in the United States for adults suffering from anemia related to chronic kidney disease who have been on dialysis for a minimum of three months. The shipment of Vafseo to dialysis centers has commenced, and Akebia recently secured significant commercial supply agreements with leading dialysis organizations. This strategic move is expected to enhance coverage for nearly all dialysis patients across the U.S., ensuring that much-needed treatment is accessible.

The Centers for Medicare & Medicaid Services (CMS) has recognized Vafseo's importance, and it qualifies for the Transitional Drug Add-On Payment Adjustment (TDAPA), which further supports its reimbursement strategies. This development provides a solid basis for the market introduction of Vafseo.

Looking Ahead: Phase 3 Clinical Trials

In addition to the commercial advancements, Akebia has ambitious plans to initiate a Phase 3 clinical trial aimed at expanding Vafseo's usage for treating anemia in late-stage CKD patients not undergoing dialysis. Following constructive feedback from the U.S. Food and Drug Administration (FDA) regarding the study protocol, Akebia is on track to start the trial in mid-2025.

John P. Butler, the CEO of Akebia, expressed confidence regarding these developments, stating that the company is poised for a transformational year. The launch of Vafseo in the U.S. market represents a potential new standard of care for CKD patients. He emphasized that the commercial team will remain focused on ensuring Vafseo's successful U.S. launch while the research team works towards the drug's expansion into the non-dialysis patient population — a segment that holds substantial unmet needs and market potential.

Accomplishments with Vafseo

• - Vafseo began shipping to dialysis centers from January 9, 2025, marking a significant milestone in its rollout.
• - Comprehensive access for Vafseo has been secured, with agreements covering virtually all dialysis patients in the U.S. This includes recent partnerships with leading dialysis organizations.
• - Research shows that a vast majority (99%) of nephrologists recognize the potential of Vafseo and are inclined to prescribe it to eligible patients, with 75% planning to do so within six months of availability.

Moreover, U.S. Renal Care has successfully enrolled over 650 patients in the VOICE clinical trial of Vafseo, further underscoring its early acceptance and clinical utility within the nephrology community.

Upcoming Presentation at J.P. Morgan Healthcare Conference

On January 16, 2025, John Butler will present further updates during the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. This presentation will provide stakeholders and investors with deeper insights into the company's plans and the anticipated impact of Vafseo on patient care.

Conclusion: Preparing for Broader Impact

With the launch of Vafseo and the upcoming Phase 3 trial, Akebia Therapeutics demonstrates a strong commitment to addressing the needs of the CKD community. The responses from healthcare providers and the marketplace indicate a favorable landscape for Vafseo, highlighting its potential to change the treatment paradigm for kidney disease. As Akebia enhances its commercial portfolio, it positions itself to become a key player within the biopharmaceutical sector focused on nephrology.