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Investing.com -- Akebia Therapeutics (NASDAQ:AKBA) stock plunged 24% Wednesday after the company announced it would not pursue a broad label for its anemia treatment Vafseo in chronic kidney disease patients not on dialysis.
The biopharmaceutical company said it failed to reach alignment with the U.S. Food and Drug Administration on the design of its proposed VALOR clinical trial for vadadustat. According to Akebia, the FDA indicated that such a trial would require "a significantly larger number of patients than proposed," resulting in substantially higher costs and longer timelines.
"Because we remain steadfast in our belief of the significant unmet need for an oral option to treat anemia in CKD patients not on dialysis, we are disappointed in the outcome of the meeting," said John P. Butler, Chief Executive Officer at Akebia.
The company noted that it was encouraged by discussions with the FDA regarding potential clinical trial designs for smaller subgroups of CKD patients, suggesting a more targeted approach might still be possible.
Vafseo (vadadustat) received FDA approval for treating anemia in adults who have been on dialysis for at least three months, with U.S. nephrologists beginning to prescribe the medication in January 2025. Akebia indicated it would focus on making Vafseo the "standard of care for patients on dialysis" rather than pursuing the broader non-dialysis dependent patient population.
The decision represents a significant setback for Akebia’s market expansion plans for Vafseo, limiting its potential patient population to those already on dialysis rather than the larger group of CKD patients not requiring dialysis.
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