Akebia Receives FDA Acceptance Of Resubmission To NDA Of Vadadustat For The Treatment Of Anemia Due To Chronic Kidney Disease
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Akebia Therapeutics, Inc. (NASDAQ:AKBA) announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for vadadustat, a treatment for anemia due to chronic kidney disease. The FDA has classified this as a class 2 response, resulting in a six-month review period, and set a user fee goal date of March 27, 2024. Akebia expects to have vadadustat available shortly after approval and is preparing for a commercial launch in the second half of 2024.
October 25, 2023 | 12:34 pm
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Akebia's resubmission of its NDA for vadadustat has been accepted by the FDA, potentially leading to a commercial launch in the second half of 2024.
The FDA's acceptance of Akebia's resubmission is a positive development for the company. If the drug is approved, it could provide a new revenue stream for Akebia, potentially leading to a positive impact on its stock price.
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