Akebia Therapeutics Updates on Vafseo® (vadadustat) Tablets Launch Progress

15 July 2024

Akebia Therapeutics, Inc., a biopharmaceutical company based in Cambridge, Massachusetts, has announced significant updates regarding the commercial launch of its product Vafseo® (vadadustat) Tablets. This comes after Akebia regained full rights to sell Vafseo in the United States following the execution of a royalty-based termination agreement with CSL Vifor. The termination simplifies operational execution and is expected to improve economic outcomes for the company. The wholesale acquisition cost (WAC) for Vafseo has been set at $1,278 for a 30-day supply.

John P. Butler, Chief Executive Officer of Akebia, highlighted that the team has been working diligently on the commercial launch activities since Vafseo's approval in late March. These efforts are aimed at driving prescriber demand and optimizing Vafseo's revenue ramp during a two-year Transitional Drug Add-on Payment Adjustment (TDAPA) period, which is expected to start in January 2025. Butler noted that establishing a properly valued WAC and effective contracting with dialysis organizations are critical components of a successful launch.

The termination agreement with CSL Vifor allows Akebia to regain rights to sell Vafseo in the U.S., thereby enabling direct contracting with dialysis organizations. This change is anticipated to facilitate more efficient operational management of the product. Under the terms, Akebia is required to make quarterly tiered royalty payments to CSL Vifor, ranging from a high single-digit percentage on annual net sales up to $450 million, to a mid-single digit percentage on annual net sales exceeding $450 million. Additionally, starting July 1, 2027, Akebia has the option to reduce the royalty agreement with a one-time payment, which would lower royalty payments to a mid-single digit percentage on annual net sales up to $450 million and eliminate royalties on sales above that amount.

In June, Akebia submitted its TDAPA application. The company expects the Healthcare Common Procedure Coding System (HCPCS) codes to be assigned in October 2024 and full TDAPA designation by January 1, 2025.

The WAC for Vafseo has been set considering its use in both dialysis and potential non-dialysis patient populations. The estimated annual cost at the minimum starting dose is around $15,500. Akebia plans to offer off-invoice and volume tier discounts as part of its contracting strategy. The company has made considerable progress in contract discussions with dialysis organizations for both its products Auryxia and Vafseo. They expect to finalize contracts with providers treating the majority of eligible Vafseo patients before January 2025.

Akebia will host an investor conference call to discuss these updates at 8:00 a.m. ET on July 11, 2024. The call will also be available via live webcast, with an online archive accessible approximately two hours after the event.

Founded in 2007, Akebia Therapeutics, Inc., focuses on developing and commercializing therapies to better the lives of people impacted by kidney diseases. The company has a strong presence in the renal care market and aims to leverage this expertise to drive the success of Vafseo.

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