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# Complete Response for Akebia Vadadustat
- URL: https://www.fdaweb.com/complete-response-for-akebia-vadadustat/
- Published: 2022-03-30T12:00:00.000Z
- Updated: 2026-09-14T17:38:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151491

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](https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-receives-complete-response-letter-fda?ref=fdaweb.com) 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.