"We could not identify a reason for the excess in noncardiovascular deaths." The company received a CRL from the FDA in March 2022; the FDA stated their NDA-supporting data did not support a favorable benefit-risk profile for the indicated population based on the failure to meet non-inferiority in MACE safety outcomes in their phase 3 trials. 4 "We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD," John P. Butler, Chief Executive Officer of Akebia, said in a statement at the time. "We continue to believe the data are supportive of a positive benefit-risk assessment of vadadustat for patients with anemia due to CKD, particularly in dialysis patients."