Akebia Therapeutics (NASDAQ:AKBA) reported positive topline data from two Phase 3 studies of vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
The first study evaluated 369 patients who initiated chronic dialysis for end-stage renal disease less than 16 weeks prior to screening and had limited exposure to recombinant erythropoiesis stimulating agents. The second study evaluated 3,554 dialysis patients currently receiving recombinant erythropoiesis stimulating agents.
Vadadustat achieved each study’s primary efficacy endpoint of mean change in hemoglobin between baseline and the primary evaluation period of weeks 24-to-36 compared to darbepoetin alfa, demonstrating non-inferiority.
“It is extremely rewarding to see this program yield clear, consistent, straightforward results,” John Butler, Akebia’s president and CEO, said in a statement.
“We believe our data uniquely positions vadadustat as a potential new oral standard of care for treating all populations of dialysis patients, including both incident and prevalent dialysis patients, with anemia due to CKD, subject to approval,” he added.
Akebia plans to conduct additional studies of vadadustat in CKD patients not on dialysis, with data expected in mid-2020. Once the Phase 3 program is complete, the company plans to submit an NDA to the FDA, as well as a marketing authorization application to the European Medicines Agency.
