AKBA - Akebia to resubmit FDA application for kidney drug by end of Q3
2023-07-18 11:14:56 ET
Akebia Therapeutics ( NASDAQ: AKBA ) said it plans to resubmit its market application to the FDA by the end of Q3 for its kidney disease drug vadadustat, which the agency declined to approve last year.
Akebia is seeking to have the drug approved to treat anemia associated with chronic kidney disease in adults on dialysis. If the agency accepts the application, it is expected to decide on whether to approve the product within six months.
Vadadustat is already approved in 34 countries, with UK regulators greenlighting the drug in May and Swiss authorities in June.
The FDA declined to approve vadasdustat in March 2022, citing safety concerns involving thromboembolic events and drug-inducted liver injury. The company had originally sought to have the drug approved for dialysis and non-dialysis patients.
The agency rejected Akebia's appeal of the decision in May, but guided the company on how to resubmit the application, with the indication narrowed to patients dependant on dialysis. The FDA also said that concerns about thromboembolic events could be addressed through product labeling while monitoring could minimize the risk of drug-induced liver damage.
More on Akebia:
- Akebia gains approval of vadadustat for anemia in Switzerland
- Akebia Therapeutics announces new finance chief
- Akebia settles last patent lawsuit related to kidney disease therapy
- Akebia jumps 16% as Piper upgrades after updates on kidney disease candidate
- Akebia Therapeutics: Buy This Undervalued Stock At Just 77% Of Revenue
For further details see:
Akebia to resubmit FDA application for kidney drug by end of Q3