Akebia Therapeutics Drops Trial Plans for Anemia Treatment After FDA Meeting
By Kelly Cloonan
Akebia Therapeutics will not start a proposed trial for its anemia treatment after meeting with the Food and Drug Administration.
The biopharmaceutical company said Tuesday it believes regulatory alignment for the trial would require a significantly larger number of patients than proposed, requiring more time and cost to complete, based on feedback from the FDA.
The proposed trial aimed to study the use of vadadustat to treat anemia in patients with late-stage chronic kidney disease not on dialysis. The treatment is already approved for such patients who have been receiving dialysis for at least three months.
As a result of the FDA's feedback, the company does not plan to initiate the trial or pursue a broad label for its Vafseo anemia treatment in patients not on dialysis.
While the company is disappointed in the outcome of the meeting was encouraged by its discussion with the FDA on smaller subgroups of chronic kidney disease patients, Chief Executive John Butler said.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
October 28, 2025 17:26 ET (21:26 GMT)
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