Core Insights - Akebia Therapeutics presented a post-hoc win odds analysis at ASN Kidney Week 2025, showing that vadadustat (Vafseo) significantly reduces the risk of all-cause mortality and hospitalization compared to darbepoetin alfa in patients with CKD-related anemia undergoing dialysis [1][5][3] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [7] - Vafseo (vadadustat) is approved for treating anemia due to chronic kidney disease in adults on dialysis for at least three months and has been available in the U.S. since January 2025 [2][9] Study Details - The analysis was based on data from two global Phase 3, open-label, randomized noninferiority trials (INNO2VATE) comparing vadadustat to darbepoetin alfa in adults with anemia associated with dialysis-dependent CKD [4] - The primary safety endpoint was the time to first adjudicated major adverse cardiovascular events (MACE), which includes death from any cause, non-fatal myocardial infarction, or non-fatal stroke [4] Statistical Analysis - The win-odds analysis indicated that the composite of all-cause mortality and hospitalizations was statistically significantly lower for patients receiving vadadustat compared to those receiving darbepoetin alfa [5][6] - The inverted win-odds ratio for vadadustat was reported as 0.93 (95% CI 0.87-0.99; P=0.03) and 0.86 (95% CI 0.81-0.95; p <0.0001) for treatment plus 28 days post last dose [8] Future Directions - Akebia aims to make Vafseo the standard of care for CKD-related anemia in dialysis patients and is advancing multiple trials, including the VOICE trial, to measure mortality and hospitalizations in real-world settings [3][26]

Core Insights - Akebia Therapeutics and Innovative Renal Care announced the broad availability of Vafseo (vadadustat) for treating anemia due to chronic kidney disease (CKD) in dialysis patients across all IRC clinics [1][2] - Vafseo was approved by the FDA in March 2024 and became commercially available in January 2025, targeting adults on dialysis for at least three months [3] Company Overview - Akebia Therapeutics is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [6] - Innovative Renal Care is a national leader in kidney care, operating over 230 dialysis centers across 28 states and Washington, D.C., emphasizing patient-centered care and partnerships with nephrologists [5] Product Details - Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates the production of erythropoietin, thereby increasing hemoglobin and red blood cell production to manage anemia [7] - The drug is indicated for adults with anemia due to CKD who have been on dialysis for at least three months and is approved for use in 37 countries [8] Market Impact - Vafseo is now accessible to over 55,000 patients through IRC's dialysis provider protocols, with expectations to expand access to more than 275,000 patients by the end of Q4 2025 [4]