Reata Puts Hopes On Partner Study To Support Bardoxolone Resubmission

Reata Pharmaceuticals, Inc. is hoping that it will be able to provide the additional information sought in the US Food and Drug Administration’s complete response letter on bardoxolone for Alport syndrome from an outcomes study by partner Kyowa Kirin Co., Ltd., the firm told its quarterly earnings call on 28 February. But the outcomes trial, which is expected to report data during the second half of 2022, is in diabetic kidney disease.

The CRL on 25 February was not a complete surprise, as the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously at its 8 December meeting against approval of bardoxolone, an antioxidant inflammation modulator, in Alport because the pivotal Phase III CARDINAL study did not adequately demonstrate that the drug can significantly slow the decline in kidney function caused by the disease. (Also see "Reata’s Bardoxolone Shot Down, But US FDA Advisors Offer Suggestions For Improved Study" - Pink Sheet, 9 December, 2021