- Kidney-disease drug developer Akebia Therapeutics ( NASDAQ: AKBA ) lost ~9% pre-market Tuesday after announcing that the FDA issued a second interim response in its appeal for lead candidate vadadustat developed as a therapy for anemia due to chronic kidney disease.
- In early 2022, the FDA rejected the treatment for CKD-linked anemia and issued an interim response in December requesting additional data for a company-submitted appeal over the decision.
- According to its latest updates on the appeal, citing resource constraints and staffing needs, the FDA's Office of New Drugs (OND) has transferred its deciding authority to Peter Stein, the director of OND. The appeal was initially assigned to a Senior Advisor within the division.
- "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," the company said, adding that a response is expected within 30 days from the completion of discussions and any follow-up.
- Read: Seeking Alpha contributor Fade The Market argued in October that the FDA's decisions to reject vadadustat "significantly decrease the likelihood of the product's approval soon."
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Akebia slips as FDA issues second response on appeal for kidney disease therapy