Akebia announces ‘positive’ results from vadadustat alternative dosing study

Akebia Therapeutics announced positive top-line results from FO2CUS, a study evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent to three times weekly oral vadadustat dosing for the maintenance treatment of anemia. The data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA in the treatment of anemia due to chronic kidney disease in patients on hemodialysis when used three times a week at the time of dialysis and with a comparable safety profile to the current standard of care. Data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA as a treatment for anemia due to chronic kidney disease when administered three times a week at the time of dialysis. Vadadustat demonstrated a similar safety profile to long-acting ESA when used three times a week.