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Akebia Could Face Long, Costly Effort To Overcome Vadadustat CRL

Company Pins Hopes On Partner Otsuka’s EMA Application

 
• By Alaric DeArment

The US FDA turned down approval for vadadustat in chronic kidney disease anemia, in a complete response letter that unexpectedly included the dialysis-dependent indication.

Akebia received a complete response letter for its CKD anemia drug, vadadustat • Source: Alamy

Akebia Therapeutics, Inc. found its hopes of getting a second product onto the market this year dashed as the US Food and Drug Administration turned down its approval application for vadadustat, a drug for anemia due to chronic kidney disease (CKD), citing safety concerns. The company will likely have to complete another trial to address the agency’s concerns.

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