"The win statistics analysis highlighted favorable outcomes and potential clinical differentiation for Vafseo that we believe are central to ensure informed clinical decision-making for nephrologists and other care providers," said Dr. Steven Burke, Chief R&D and Medical Officer at Akebia. "As we work toward our goal to make Vafseo standard of care in patients with anemia due to CKD receiving dialysis, we believe publication in JASN further validates the strength of the vadadustat dataset and supports strong engagement with prescribers, providers and payors."

As reported in the Research Letter titled, "Comparing Vadadustat and Darbepoetin in Maintenance Dialysis with chronic kidney disease (CKD)-Related Anemia," vadadustat demonstrated a statistically significant improvement relative to the erythropoiesis-stimulating agent (ESA), darbepoetin alfa, on a hierarchical composite endpoint of all-cause mortality and hospitalization in patients with anemia due to chronic kidney disease receiving dialysis, which we believe is clinically meaningful. This post hoc analysis was conducted among all randomized patients who received at least one dose of study drug in the INNO2VATE program. A hierarchical composite end point of time to all-cause mortality and hospitalization with consideration of exposure time was analyzed using win statistics. Among patients with dialysis-dependent CKD and CKD-related anemia, those randomized to vadadustat experienced lower rates of the composite end point of all-cause mortality or hospitalization compared with patients randomized to darbepoetin alfa.

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.