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Akebia Therapeutics, Inc. (AKBA) VOICE Trial Shows Safety Superiority vs ESA

Akebia said the USRC-led VOICE trial in 2,116 dialysis patients showed vadadustat dosed three times weekly was superior to ESA on a composite of all-cause mortality and hospitalization, with a win odds of 1.16 and p=0.0016.

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What happened

Akebia said the USRC-led VOICE trial in 2,116 dialysis patients showed vadadustat dosed three times weekly was superior to ESA on a composite of all-cause mortality and hospitalization, with a win odds of 1.16 and p=0.0016.

Confirmed

Global impact / market context

Better safety results could persuade dialysis doctors to prescribe Vafseo instead of ESAs, which means existing anemia drugs. Fewer serious adverse events and steadier hemoglobin may support uptake, but Akebia's U.S. label covers only dialysis patients, so revenue depends on adoption within that group.

Analyst inference

This adds mid-cycle support to Vafseo's clinical profile after its 2024 U.S. approval. The larger driver for the stock would be real-world adoption, reimbursement traction, which means insurers paying for the drug, and provider network uptake that turns into sales growth.

Analyst inference

What to watch

  1. The trial randomized 2,116 patients, a large sample that strengthens credibility and potential practice impact at dialysis centers. Confirmed
  2. Watch whether prescribers shift toward Vafseo given fewer serious adverse events, since that safety profile may aid uptake. Proposed
  3. Track real-world adoption, reimbursement traction, and guideline or provider network uptake, because those translate the trial result into sales growth for Akebia. Analyst inference

Evidence