Massachusetts-based biopharma Akebia Therapeutics announced this week that it had received its second interim response from the FDA to its resolution request regarding the company’s Complete Response Letter for its anemia drug, vadadustat.
The company first received the CRL for vadadustat’s NDA in March of 2022, when the FDA concluded that the data in the application did not support a favorable benefit-risk assessment of the drug in dialysis and non-dialysis patients and asked Akebia to conduct new clinical trials.
Now, Akebia was notified that due to agency resource and staffing constraints the deciding authority for the appeal will now be Peter Stein, Director of the OND. Dr. Stein has indicated the need to seek internal consultation with nephrology, cardiology and liver safety experts in the Office of New Drugs before rendering a decision.
Vadadustat, designed as a therapy for anemia due to chronic kidney disease, was developed in collaboration with Otsuka Pharmaceutical. The drug is a hypoxia-inducible prolyl hydroxylase inhibitor, which helps to stabilize HIF. A few months after the FDA rejected their application, Otsuka decided to terminate its global license agreements with Akebia Therapeutics.
Akebia expects to be notified of a final decision within thirty days of Dr. Stein completing discussions and consultations.
