Akebia receives interim response from FDA on appeal of vadadustat submission

Akebia Therapeutics received an interim response from the FDA to its Formal Dispute Resolution Request regarding the Complete Response Letter received in March 2022 for vadadustat, which had been submitted to the FDA as a treatment for anemia due to chronic kidney disease in adult patients. Akebia met with the FDA in November to discuss its appeal and subsequently received a request for additional clarifying information from the Office of New Drugs, Center for Drug Evaluation and Research, which is deciding the appeal. Akebia remains engaged with the FDA and expects to submit the requested information to the FDA in January 2023. Based on FDA guidance, Akebia expects to receive a response to its appeal 30 days from the date Akebia submits the requested information.