- Akebia Therapeutics Inc AKBA and its collaborator Otsuka Holdings OTSKY have announced that the FDA has accepted to review vadadustat's marketing application for anemia due to chronic kidney disease.
- The application covers both adult patients, on dialysis and not on dialysis.
- The agency's target action date is March 29, 2022.
- The FDA also indicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application.
- In addition, Otsuka is working with Akebia to prepare a Marketing Authorization Application for vadadustat for submission to the European Medicines Agency expected in 2021.
- Price Action: AKBA shares are up 8.28% at $3.80 during the premarket session on the last check Tuesday.
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