Reata says partner Kyowa Kirin’s outcomes study of bardoxolone in chronic kidney disease may address the questions cited by the FDA in its complete response letter for Alport syndrome.
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.
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