Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company received a second interim response from the U.S. Food and Drug Administration to its Formal Dispute Resolution Request regarding the Complete Response Letter for vadadustat received in March 2022.
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 Peter Stein, M.D., Director, OND. The appeal was originally assigned to a Senior Advisor within the OND.
Dr. Stein has indicated a need to seek internal consultation with nephrology, cardiology and liver safety experts in the Office of New Drugs to complete the review and render a decision. 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 thirty days of Dr. Stein completing the discussions and any required follow up.
https://finance.yahoo.com/news/akebia-therapeutics-received-interim-response-113000748.html
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