25 February 2022 - Reata Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the new drug application for bardoxolone methyl for the treatment of patients with chronic kidney disease caused by Alport syndrome.

The complete response letter indicates that the FDA cannot approve the new drug application in its present form. 

Based on its review, the FDA concluded that it does not believe the submitted data demonstrates that bardoxolone methyl is effective in slowing the loss of kidney function in patients with Alport syndrome and reducing the risk of progression to kidney failure and has requested additional data to support the efficacy and safety of bardoxolone methyl.

Read Reata Pharmaceuticals press release