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# Akebia Vadadustat Dispute Resolution Delayed
- URL: https://www.fdaweb.com/akebia-vadadustat-dispute-resolution-delayed/
- Published: 2023-02-21T12:00:00.000Z
- Updated: 2026-09-14T18:16:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153816

FDA has notified Akebia Therapeutics that due to agency resource constraints and staffing needs, the deciding authority for the company’s formal dispute resolution request about the complete response letter received on 3/2022 for its vadadustat will be CDER Office of New Drugs (OND) director **Peter Stein**. The company [says](https://ir.akebia.com/node/12856/pdf?ref=fdaweb.com) the appeal was originally assigned to an OND senior advisor.

Vadadustat is described as an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. FDA issued a complete response letter on 3/29/22 for the company NDA for vadadustat to treat anemia due to chronic kidney disease. In 11/2022, the company submitted a formal dispute resolution request focused on the favorable balance of the risks and benefits of the drug in the proposed indication.

“Dr. Stein has indicated a need to seek internal consultation with nephrology, cardiology, and liver safety experts in OND to complete the review and render a decision,” Akebia says. “Dr. Stein indicated that he will do all he can to facilitate the appropriate meetings and discussions given the delay resulting from the staffing change. Akebia expects to be notified of a response to the appeal within 30 days of Dr. Stein completing the discussions and any required follow-up.”