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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.