Posted by Michael Wonder on 30 Mar 2022
Akebia Therapeutics receives complete response letter from the FDA for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients
30 March 2022 - Akebia Therapeutics today announced that the U.S. FDA has issued a complete response letter to Akebia's new drug application for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor under review for the treatment of anemia due to chronic kidney disease.
The FDA issues a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.
The FDA concluded that the data in the new drug application do not support a favourable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients.
