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 met with the U.S. Food and Drug Administration (FDA) Office of New Drugs (OND) deciding authority to discuss Akebia’s Formal Dispute Resolution regarding the Complete Response Letter for vadadustat received in March 2022.
AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)” alt=”Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)”>
In February 2023, Akebia received notification from OND that Peter Stein, M.D., Director, OND, assumed responsibility as the deciding authority for the appeal. At the recent meeting, Akebia had a productive discussion with Dr. Stein, who indicated he is continuing internal consultation with experts in OND to complete the review and render a decision.
Akebia expects to be notified of a response to the appeal within thirty days of Dr. Stein completing his internal discussions, potentially within the second quarter of 2023.
