Akebia reports vadadustat reduces mortality in kidney disease patients

Akebia Therapeutics Inc. (NASDAQ: AKBA) announced that a post-hoc analysis of its drug vadadustat showed a statistically significant reduction in a composite endpoint of all-cause mortality and hospitalization compared to darbepoetin alfa in dialysis patients with chronic kidney disease-related anemia.

The analysis, published in the Journal of the American Society of Nephrology, examined data from the company's global Phase 3 INNO2VATE program. The study used win statistics to analyze a hierarchical composite endpoint of time to all-cause mortality and hospitalization among all randomized patients who received at least one dose of study drug.

Patients randomized to vadadustat experienced lower rates of the composite endpoint compared with those receiving darbepoetin alfa, an erythropoiesis-stimulating agent. The analysis included patients with dialysis-dependent chronic kidney disease and related anemia.

Vadadustat is marketed under the brand name Vafseo and received approval for treating anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. The drug has been available in the United States since January 2025.

The medication carries a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. The warning states that no trial has identified a hemoglobin target level, dose, or dosing strategy that does not increase these risks.

Akebia is a Cambridge, Massachusetts-based biopharmaceutical company focused on kidney disease treatments. The company was founded in 2007.

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