Akebia slumps as it updates on FDA response on vadadustat appeal

22 February 2023

USA-based Akebia Therapeutics (Nasdaq: AKBA) said yesterday that it has received a second interim response from the US Food and Drug Administration (FDA) to its formal dispute resolution request regarding the Complete Response Letter (CRL) for vadadustat received in March 2022, with the news sending the firm’s plunging 25.5% to $0.65.

Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor which was under review for the treatment of anemia due to chronic kidney disease (CKD). Following the first CRL, the company’s stock price fell by more than 65%.

Akebia received notification from the Office of New Drugs (OND), Center for Drug Evaluation and Research, that due to agency resource constraints and staffing needs the deciding authority for the appeal will now be Dr Peter Stein, director the OND. The appeal was originally assigned to a senior advisor within the OND.

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