By Overview
Akebia Therapeutics, a biopharmaceutical company based in Cambridge, Massachusets, has announced that the U.S. Food and Drug Administration (FDA) has acknowledged the completion of their resubmitted application. This application seeks approval for vadadustat as a treatment for anemia due to chronic kidney disease in adults on dialysis.
FDA Review Process
The FDA has stated that a six-month review period will be conducted, starting from the date of resubmission. The target action date has been set for March 27, 2024.
Previous Application Rejection
Akebia’s initial application was rejected by the FDA in March 2022. The agency cited insufficient data to support a favorable benefit-risk assessment of vadadustat.
Resubmission Details
In their resubmission, Akebia included post-marketing safety data from tens of thousands of patients in Japan. Notably, vadadustat has already been approved and available on the market in Japan for over three years.
Future Plans
If Akebia Therapeutics receives FDA approval, they are preparing for a U.S. commercial launch of vadadustat in the second half of 2024.
For more information, please contact Akebia Therapeutics directly.
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