Akebia Awaits FDA Word On Second Crack At Vadadustat
The FDA, which turned away Akebia's initial application last March 2022, has a target action of Wednesday on the company's resubmission, which included safety data from tens of thousands of patients in Japan, where vadadustat was approved in mid-2020. Akebia has said it is prepping for a U.S. commercial launch of vadadustat in the second half if it gets an FDA green light.