Akebia Ends CSL Vifor Deal, Reveals High Price for CKD Anemia Drug Vafseo

Akebia Therapeutics announced on Thursday that it has fully regained rights to the oral medication Vafseo (vadadustat) for treating chronic kidney disease (CKD) anemia. This follows an agreement with its commercialization partner CSL Vifor to terminate their existing contract. Under the new royalty-based termination agreement, Akebia now holds exclusive commercialization rights to Vafseo in the United States and can immediately begin direct dealings with dialysis organizations.

In exchange for these rights, CSL Vifor will receive quarterly tiered royalties. These royalties will start in the high single-digit percentage range of annual net sales up to $450 million and decrease to a mid-single digit percentage for sales exceeding $450 million. From July 1, 2027, Akebia will have the option to reduce the royalty payments with a one-time payment to CSL Vifor.

John Butler, CEO of Akebia, expressed optimism about the future of Vafseo, stating that the termination agreement allows the company to expedite contract negotiations. He believes that by January 2025, contracts will be in place with dialysis providers that treat most eligible Vafseo patients.

On the same day as the announcement of the contract termination, Akebia also disclosed the price for Vafseo. The wholesale acquisition cost for the drug is set at $1,278 for a 30-day supply at its minimum starting dose, translating to approximately $15,500 annually. Butler emphasized that the pricing strategy considered Vafseo’s potential use in non-dialysis patients, pointing out that the Inflation Reduction Act restricts companies from adjusting their pricing frequently. "You have one opportunity to price your drug," Butler noted, highlighting the importance of strategic pricing for the drug’s expanded label.

Vafseo is a small molecule drug that inhibits the HIF-PH enzyme, a critical component in the cellular response to low oxygen levels. This inhibition triggers the body’s response to hypoxia, stimulating the production of erythropoietin and thereby addressing anemia.

The FDA approved Vafseo in March 2024 for treating anemia due to CKD, but the approval was limited to patients who had been on dialysis for at least three months. Akebia is currently planning to expand Vafseo’s use to non-dialysis populations and intends to discuss this with the FDA within the year.

Upon its approval, Butler described Vafseo as providing an alternative treatment option for CKD-associated anemia. However, the drug carries a boxed warning due to increased risks of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.

This strategic shift allows Akebia to focus on broadening the reach of Vafseo, potentially improving care for a wider range of patients suffering from CKD anemia. As the company advances its plans, the hope is that Vafseo will soon become a more widely available treatment option, offering a new alternative for those in need.