Akebia Therapeutics on Thursday said it regained full U.S. rights to its chronic kidney disease anemia drug Vafseo, which the biotech has priced at around $15,500 per year.
Akebia Therapeutics on Thursday announced that it has regained full rights to the oral drug Vafseo (vadadustat) for chronic kidney disease anemia after its commercialization partner CSL Vifor agreed to terminate their contract.
According to the biotech, CSL agreed to a royalty-based termination agreement which gives Akebia the exclusive commercialization rights to Vafseo in the U.S., as well as the ability to work directly with dialysis organizations “effective immediately.”
In return, CSL is entitled to quarterly tiered royalties which will range from high single-digit percentage of annual net sales up to $450 million to a mid-single digit percentage of annual net sales beyond $450 million. Staring July 1, 2027, Akebia will have the option to “buy down” this royalty agreement in exchange for a one-time payment to CSL.
“Having now executed this agreement with CSL Vifor, we can accelerate contracting discussions and expect to have contracts in place with dialysis providers treating the vast majority of eligible Vafseo patients before January 2025,” Akebia CEO John Butler said in a statement.
Concurrent with the announcement of the contract termination, Akebia on Thursday also unveiled the price tag for Vafseo. The biotech set the drug’s wholesale acquisition cost at $1,278 per 30-day supply at its minimum starting dose. On a yearly basis, Vafseo will cost around $15,500.
The drug’s potential expansion into patients who are not on dialysis was a key factor in deciding its cost, Butler said in an investor call, noting that the Inflation Reduction Act limits companies’ ability to adjust their pricing. “You have one opportunity to price your drug,” Butler contended, noting that the biotech considered an expanded label in its “strategic pricing.”
Vafseo is a small molecule drug that works by blocking the HIF-PH enzyme, which is an important player in the cellular response to low oxygen levels. Through this mechanism of action, Vafseo triggers the body’s response to hypoxia and promotes the production of erythropoietin for anemia.
In March 2024, the FDA approved Vafseo for the treatment of anemia due to chronic kidney disease (CKD), but notably restricted its use in patients who had been undergoing dialysis for at least three months. Akebia is looking to expand Vafseo’s label to cover non-dialysis populations, for which it is planning to hold discussion with the FDA within the year.
At the time of its approval, Butler said that Vafseo could provide patients with “an alternative treatment option” for anemia associated with CKD. The drug carries a boxed warning for an elevated risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access.
