Akebia Therapeutics Drops Plans to Broaden Vafseo Indication After FDA Rejection

Akebia Therapeutics (NASDAQ: AKBA) shares plunged after the biopharmaceutical company said it will no longer pursue an expanded indication for its anemia drug Vafseo (vadadustat) in chronic kidney disease (CKD) patients not on dialysis.

Regulatory Setback

The decision follows the FDA’s rejection of Akebia’s proposed VALOR trial design, which aimed to support approval for Vafseo in the broader CKD population.
The agency indicated that a much larger and more comprehensive study would be required to achieve regulatory alignment, adding significant time and cost to the program.

Strategic Decision

Given the expanded requirements, Akebia announced it is discontinuing efforts to move forward with this specific indication.
The company said it will focus its resources on other programs and on supporting Vafseo’s current approved use in dialysis-dependent patients.

Market Reaction

Investors reacted sharply to the update, sending Akebia shares down 22% in early trading. The decision represents a major setback for Akebia’s long-term growth plans, as the non-dialysis CKD segment represents a large untapped market for anemia treatment.