Akebia says FDA staffing constraints are throwing a roadblock into appeal process

Three months after Akebia Therapeutics formally appealed an FDA decision to reject its kidney disease med, the company says staffing constraints at the U.S. regulatory body are delaying the review process.

Akebia says Peter Stein, M.D., director of the FDA’s Office of New Drugs, will now be the deciding authority for its appeal “due to agency resource constraints and staffing needs,” according to a release Tuesday. Akebia was originally assigned a senior adviser within the FDA.

In October, Akebia formally asked the FDA to reconsider its March 2022 rejection of vadadustat as a treatment for patients with anemia due to chronic kidney disease. The agency cited safety concerns regarding blood clots and drug-induced liver injury in its initial rejection. Akebia received its first interim response from the agency in December. 

Stein has relayed to Akebia that he’ll need to consult internal disease experts to complete the review and make a decision, the biotech said today. He’s also explained to the sponsor that “he will do all he can to facilitate the appropriate meetings and discussions given the delay resulting from the staffing change,” according to the company.

Akebia noted that it expects a response to the appeal within 30 days of Stein completing his review and any additional follow-up that’s requested. It’s unclear, however, how long that review process could take. 

A spokesperson for the FDA’s Center for Drug Evaluations and Research told Fierce Biotech that the agency can’t comment on existing or potential applications. 

The update means vadadustat’s fate in the U.S. remains in limbo. The treatment was approved in Japan in June 2020 and is awaiting a decision from European regulators that is slated to come down within a matter of weeks. The company said in its third-quarter earnings report that it expected a decision in the first quarter of 2023. 

The med was originally slated to be a joint commercial effort between Akebia and Otsuka Pharmaceutical, but the deal fell apart in June 2022 following the FDA rejection and subsequent layoffs. The terminated deal handed back to Akebia commercial rights to the drug in the U.S., China and Europe as well as other territories.