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.
Akebia Could Face Long, Costly Effort To Overcome Vadadustat CRL
Company Pins Hopes On Partner Otsuka’s EMA Application
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.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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