Therapy Areas: Diabetes
Reata Pharmaceuticals Submits Marketing Authorization Application to the European Medicines Agency for Bardoxolone Methyl in Chronic Kidney Disease Caused by Alport Syndrome
29 October 2021 - - US-based clinical-stage biopharmaceutical company Reata Pharmaceuticals, Inc. (NASDAQ: RETA) has submitted a Marketing Authorization Application for bardoxolone methyl to the European Medicines Agency for the treatment of patients with chronic kidney disease caused by Alport syndrome, the company said.

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 US Food and Drug Administration of the company's New Drug Application for the treatment of CKD caused by Alport syndrome in the US with a Prescription Drug User Fee Act date of February 25, 2022.

Alport syndrome is a rare, genetic form of CKD caused by mutations in the genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney. Alport syndrome affects both children and adults.

The kidneys of patients with Alport syndrome progressively lose the capacity to filter waste products out of the blood, which can lead to end-stage kidney disease and the need for chronic dialysis treatment or a kidney transplant.

In patients with the most severe forms of the disease, approximately 50% progress to dialysis by age 25, 90% by age 40, and nearly 100% by age 60.

According to the Alport Syndrome Foundation, Alport syndrome affects approximately 30,000 to 60,000 people in the United States.

There are currently no therapies approved to treat CKD caused by Alport syndrome.

Bardoxolone is an investigational, once-daily, orally administered activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.

The FDA has granted Orphan Drug designation to bardoxolone for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease. The European Commission has granted Orphan Drug designation in Europe to bardoxolone for the treatment of Alport syndrome.

In addition to the CARDINAL Phase 3 study for the treatment of CKD caused by Alport syndrome, bardoxolone is currently being studied in FALCON, a Phase 3 study for the treatment of CKD caused by ADPKD, MERLIN, a Phase 2 study for the treatment of patients with CKD at risk of rapid progression, and AYAME, a Phase 3 study for the treatment of diabetic kidney disease that is being conducted by our licensee, Kyowa Kirin Co., Ltd., in Japan.

Bardoxolone treatment has produced positive results in Phase 2 studies in patients with CKD caused by ADPKD, IgA nephropathy, focal segmental glomerulosclerosis, and type 1 diabetes.

Kyowa Kirin submitted an NDA in Japan to the Ministry of Health, Labour and Welfare for bardoxolone for improvement of renal function in patients with Alport syndrome, and the application is currently under review.

Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation.

Reata's two most advanced clinical candidates, bardoxolone and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
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