Reata Pharmaceuticals Gets Negative Vote From FDA Advisory Panel on Bardoxolone Methyl

By Josh Beckerman

Reata Pharmaceuticals Inc. received a negative opinion from a U.S. Food and Drug Administration advisory committee for its New Drug Application for bardoxolone methyl for patients with chronic kidney disease caused by Alport syndrome.

Reata shares were halted all day Wednesday.

The panel "voted no on the question of whether the provided evidence demonstrated that bardoxolone is effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits outweigh its risks."

Reata said it is disappointed with the vote and will continue to work closely with the FDA to provide additional information and data before the Feb. 25 Prescription Drug User-Fee Act date.

The FDA isn't required to follow the advice of its advisory panels, but generally does so.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

December 08, 2021 18:28 ET (23:28 GMT)

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