The agency cited an increased risk of thromboembolic events driven by vascular access thrombosis in dialysis patients and increased risk of drug-induced liver injuries.
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for vadadustat, a potential treatment for anemia due to chronic kidney disease (CKD).
The CRL, issued to Akebia Therapeutics, is based on data the FDA said does not support a favorable benefit-risk assessment of the treatment for dialysis and non-dialysis patients with safety concerns over the failure to meet non-inferiority in MACE in the non-dialysis patient population.
There was also an increased risk of thromboembolic events driven by vascular access thrombosis in dialysis patients and an increased risk of drug-induced liver injuries.
The company is able to rectify some of the concerns outlined in the letter through new clinical trials.
"We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD. 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," said John P. Butler, Chief Executive Officer of Akebia, in a statement. "Despite this setback, we continue to work toward our purpose to better the lives of people impacted by kidney disease."
Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor aimed at mimicking the physiologic effect of altitude on oxygen availability.