Akebia announces JASN published analysis from vadadustat phase 3 program

Akebia (AKBA) Therapeutics announced that the Journal of the American Society of Nephrology, JASN, has published pre-specified analyses for the U.S. and non-U.S. patient subgroups from the vadadustat global phase 3 clinical program, which included two trials in patients with dialysis-dependent chronic kidney disease and two trials in patients with non-dialysis-dependent CKD. The vadadustat global phase 3 clinical trials were open-label, randomized, noninferiority trials that compared the safety and efficacy of vadadustat with darbepoetin alfa in adult patients with CKD-related anemia. Data from the pre-specified analyses for the U.S. patient subgroup demonstrate that among patients with DD-CKD, safety and efficacy of vadadustat and darbepoetin alfa in the U.S. and outside the U.S. were similar. Among the U.S. patient subgroup with NDD-CKD, safety and efficacy outcomes were similar, but the risk for major adverse cardiovascular event with vadadustat was higher than darbepoetin alfa outside the United States.