Reata Pharmaceuticals Submits Marketing Authorization Application to the European Medicines Agency for Bardoxolone Methyl in Chronic Kidney Disease Caused by Alport Syndrome

Reata Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced its submission of a Marketing Authorization Application (MAA) for bardoxolone methyl to the European Medicines Agency (“EMA”) for the treatment of patients with chronic kidney disease (“CKD”) caused by Alport syndrome.

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This MAA submission is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial. This submission follows the acceptance for filing by the U.S. Food and Drug Administration (“FDA”) of the Company’s New Drug Application (“NDA”) for the treatment of CKD caused by Alport syndrome in the U.S. with a Prescription Drug User Fee Act (“PDUFA”) date of February 25, 2022.

“With both our NDA and MAA filings under review, we have taken a step forward on our goal to bring bardoxolone to patients with CKD caused by Alport syndrome,” said Warren Huff, Reata’s President and Chief Executive Officer. “We look forward to working closely with the EMA during the review process. Bardoxolone may be the first therapy approved to slow the progression of kidney disease in patients with this serious and debilitating disease.”

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