Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), today announced the outcome of the U.S. Food and Drug Administration (“FDA”) Cardiovascular and Renal Drugs Advisory Committee (“Committee”) meeting on bardoxolone methyl (“bardoxolone”) for the treatment of patients with chronic kidney disease (“CKD”) caused by Alport syndrome.
The Committee voted no on the question of whether the provided evidence demonstrated that bardoxolone is effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits outweigh its risks.
“We are disappointed with today’s outcome of the Committee’s vote regarding bardoxolone, an investigational drug with a novel mechanism of action,” said Warren Huff, Reata’s President and Chief Executive Officer. “We believe the scientific evidence supports bardoxolone approval in the U.S. for CKD in patients with Alport syndrome, which is one of the most rapidly progressive forms of CKD. We will continue to work with the FDA to answer any questions they may have.”
While the FDA is not required to follow the committee's vote, the agency considers the committee's recommendations when making its decision. Reata will continue to work closely with the agency to provide additional information and data until the upcoming Prescription Drug User-Fee Act (“PDUFA”) date of February 25, 2022.
About Alport Syndrome
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.
About Bardoxolone
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 (“ADPKD”).
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. (“Kyowa Kirin”), 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.
We submitted a Marketing Authorization Application for bardoxolone to the European Medicines Agency for the treatment of patients with CKD caused by Alport syndrome, and the application is currently under review. 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.
About Reata
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved ...
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