Core Insights - Akebia Therapeutics has published significant data regarding Vafseo (vadadustat) in the Journal of the American Society of Nephrology, focusing on its safety and efficacy in treating anemia related to chronic kidney disease (CKD) [1][2][4] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company dedicated to improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5] - The company aims to advance the understanding and treatment of kidney diseases through high-impact research [4] Product Information - Vafseo (vadadustat) is a once-daily oral medication approved by the U.S. FDA in March 2024 for treating anemia due to CKD in adults on dialysis for at least three months, and it has been available in the U.S. since January 2025 [3][6] - Vafseo functions as a hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulating the production of erythropoietin to manage anemia [6] Clinical Trial Insights - The global phase 3 clinical trials for vadadustat were open-label, randomized, and noninferiority trials comparing its safety and efficacy to darbepoetin alfa in adult patients with CKD-related anemia [2] - In the U.S. patient subgroup with dialysis-dependent CKD, the safety and efficacy of vadadustat were found to be similar to darbepoetin alfa, while in non-dialysis-dependent CKD patients, vadadustat showed a higher risk for major adverse cardiovascular events (MACE) outside the U.S. [2] Research Publication - The analyses published in JASN reflect the importance of geographic-specific data in understanding treatment outcomes for CKD-related anemia, highlighting how regional differences can affect clinical trial results [4]