FDA Issues CRL for Vadadustat for Anemia

The FDA cited safety concerns related to vadadustat, which is under review for the treatment of anemia due to chronic kidney disease.

The FDA has issued a complete response letter to Akebia Therapeutic's new drug application for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor under review for the treatment of anemia due to chronic kidney disease (CKD).

The agency indicted that the data do not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients. The FDA expressed safety concerns noting failure to meet non-inferiority in major adverse cardiovascular events (MACE) in the non-dialysis patient population, the increased risk of thromboembolic events, driven by vascular access thrombosis in dialysis patients, and the risk of drug-induced liver injury.

The CRL stated that Akebia could explore ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials. Akebia will discuss the details of the CRL with its collaboration partners and request a meeting with the FDA.

In October 2021, Akebia’s collaboration partner, Otsuka Pharmaceutical submitted an initial marketing authorization application for vadadustat to the European Medicines Agency; the review is ongoing.