Vafseo® (vadadustat) Dialysis Dependent Patient Post Hoc Data Analysis: Composite of All-Cause Mortality and Hospitalization Outcomes Statistically More Favorable for Patients Receiving Vadadustat vs. ESAs

CAMBRIDGE, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the presentation of a post-hoc win odds analysis of all-cause mortality and hospitalization from the Phase 3 INNO2VATE trials of vadadustat at the American Society of Nephrology Kidney Week 2025 (ASN Kidney Week). The presentation entitled, “Win-Odds Analysis of Deaths and Hospitalization in Patients taking Vadadustat or Darbepoetin Alfa for CKD-Related Anemia Undergoing Dialysis,” demonstrated favorable and statistically significant effects of Vafseo relative to the erythropoiesis-stimulating agent (ESA) darbepoetin alfa on the composite endpoint of death or hospitalization.

Vafseo® (vadadustat) is approved for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo has been available in the U.S. since January 2025.

“The win-odds statistical method is a useful tool to prioritize clinically meaningful endpoints and account for all events in the order of clinical importance,” said Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Stanford University School of Medicine. “This analysis showed that patients randomized to vadadustat experienced a lower risk of death or hospitalization compared with patients randomized to darbepoetin alfa. Physicians can consider these findings when selecting medications for the treatment of anemia in patients receiving maintenance dialysis.”

“As we work toward our goal to make Vafseo standard of care for the treatment of CKD-related anemia in patients receiving dialysis, we recognize the value of sharing new analysis of data on well-accepted outcomes like all-cause mortality and hospitalization that can inform care decisions,” said Steven Burke, MD, Senior Vice President and Chief Research & Development Officer at Akebia. “We are also actively advancing multiple trials of Vafseo in real-world clinical settings, including VOICE, a collaborative clinical trial of Vafseo, also designed to measure mortality and hospitalizations. We are grateful to our partners within dialysis organizations and various academic settings, including Dr. Chertow and his team, who clearly share our commitment to persons living with kidney disease.”

Study Details:

The post-hoc win-odds analysis was based on data from two global Phase 3, open-label, randomized (1:1), noninferiority trials (INNO2VATE) comparing vadadustat treatment vs darbepoetin alfa in adults with anemia associated with incident or prevalent dialysis-dependent chronic kidney disease. The primary safety endpoint in the primary analysis was time to first adjudicated MACE (a composite endpoint of death from any cause, non-fatal myocardial infarction, or non-fatal stroke).

In this post-hoc win-odds analysis of INNO2VATE data, the hierarchical composite of 1) all-cause mortality and 2) hospitalizations was statistically significantly lower for those patients receiving vadadustat compared to darbepoetin alfa.

Study Analysis:

On study analysis: Inverted win-odds 0.93, 95% CI (0.87-0.99); P=0.03 (vada loss count+ 0.5*ties)/ (vada win count + 0.5*ties)On treatment + 28 days post last dose: Inverted win-odds ratio 0.86, 95% CI (0.81, 0.95); p