March 1, 2021
Reata has submitted an NDA to the FDA for bardoxolone methyl for the treatment of chronic kidney disease caused by Alport Syndrome. Reata has requested priority review for the application. The submission was based on the results of the phase 2/3 CARDINAL study which demonstrated statistically significant improvement in kidney function as measured by eGFR with bardoxolone vs placebo.
The timing of the NDA submission is in line with expectations (1Q guidance by the company). If Reata is granted priority review an approval can be expected as early as 4Q 2021 with launch in early 2022, making bardoxolone the first approved drug specifically for the treatment of CKD in Alport Syndrome. Reata expects that the FDA would have an AdCom meeting to discuss the NDA.
Source: Reata press release