Akebia: FDA Accepts Resubmission of Vadadustat Application

By Colin Kellaher

Akebia Therapeutics on Wednesday said the U.S. Food and Drug Administration has acknowledged that the biopharmaceutical company's resubmitted application seeking approval of vadadustat as a treatment for anemia due to chronic kidney disease in adults on dialysis is complete.

The Cambridge, Mass., company said the FDA has set a six-month review period from the date of resubmission, with a target action date of March 27, 2024.

The FDA turned away Akebia's initial application in March 2022, saying the company's data didn't support a favorable benefit-risk assessment of vadadustat.

Akebia said its resubmission included post-marketing safety data from tens of thousands of patients in Japan, where vadadustat is approved and has been on the market for more than three years.

The company said it is preparing for a U.S. commercial launch of vadadustat in the second half of 2024 if it wins FDA approval.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

October 25, 2023 09:00 ET (13:00 GMT)

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