BioCentury
ARTICLE | Regulation

Reata sheds value as FDA reviewers doubt bardoxolone’s benefit 

Briefing document suggests FDA could deal Reata a setback in Alport syndrome 

December 6, 2021 11:46 PM UTC

Reata’s bardoxolone could be headed toward another disappointment as briefing documents released ahead of Wednesday’s advisory committee meeting said FDA reviewers aren’t convinced of the therapy’s clinical benefit in a renal indication.

In a document released Monday, FDA reviewers wrote that data in the NDA from Reata Pharmaceuticals Inc. (NASDAQ:RETA) do not establish bardoxolone methyl’s efficacy at slowing the loss of kidney function in patients with Alport syndrome and reducing the risk of progression to kidney failure. Bardoxolone’s PDUFA date is Feb. 25...