Akebia Therapeutics Shares Rise 13% After FDA Letter for Vadadustat

By Chris Wack

Akebia Therapeutics shares were up 13% to $1.28 after the company said it received a written response from the Office of New Drugs of the U.S. Food and Drug Administration to its Formal Dispute Resolution Request regarding a Complete Response Letter received in March 2022 for vadadustat.

The biopharmaceutical company said the letter stated its appeal was denied, but the letter provided a path forward for the company to resubmit the new drug application for vadadustat for the treatment of anemia due to chronic kidney disease for dialysis dependent patients.

The letter addressed issues outlined in the CRL, provided feedback and conclusions on those issues, and outlined information to be included in an NDA resubmission, which didn't include the generation of additional clinical data.

The letter noted a concern about the risk for drug-induced liver injury and concern that ongoing monitoring would be less uniformly implemented once commercially available than in the clinical trial. The Office of New Drugs concluded that while drug-induced liver injury remains a concern, it appears modest in intensity and is potentially manageable with appropriate monitoring.

Akebia plans to include post-approval data from Japan in the NDA resubmission, where tens of thousands of Japanese patients with chronic kidney disease have been exposed to vadadustat to date.

Vadadustat is currently approved for use in 33 countries.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

May 30, 2023 10:42 ET (14:42 GMT)

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