Complete Response for Akebia Vadadustat

FDA has issued a complete response letter for Akebia Therapeutics’ NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor under review for treating anemia due to chronic kidney disease. The company says FDA concluded the data in the NDA do not support a favorable benefit/risk assessment of vadadustat for dialysis and non-dialysis patients.

The agency expressed safety concerns, Akebia says, noting failure to meet non-inferiority in major adverse cardiovascular events 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.

FDA indicated the company could explore ways to potentially demonstrate a favorable benefit/risk assessment through new clinical trials and the company says it will discuss the situation with its collaboration partners and request a meeting with FDA.