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

Rhea-AI Summary

Reata Pharmaceuticals (NASDAQ: RETA) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for bardoxolone methyl, aimed at treating chronic kidney disease (CKD) due to Alport syndrome. This follows the acceptance of their New Drug Application (NDA) by the FDA, with a Prescription Drug User Fee Act (PDUFA) date set for February 25, 2022. Bardoxolone holds Orphan Drug designation in both the U.S. and Europe, targeting a rare genetic disorder affecting up to 60,000 individuals in the U.S.

Positive

• Submission of MAA for bardoxolone methyl to EMA enhances market potential.
• Bardoxolone is on track to be a first approved therapy for CKD due to Alport syndrome.
• FDA has accepted the NDA for the same indication, increasing investor confidence.

Negative

• Timing and success of regulatory approvals remain uncertain.

PLANO, Texas & ZUG, Switzerland--(BUSINESS WIRE)-- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a clinical-stage biopharmaceutical company, today announced its submission of a Marketing Authorization Application (“MAA”) for bardoxolone methyl (“bardoxolone”) to the European Medicines Agency (“EMA”) for the treatment of patients with chronic kidney disease (“CKD”) caused by Alport syndrome.

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.”

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”). 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. (“Kyowa Kirin”), 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.

About Reata Pharmaceuticals, Inc.

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. We possess exclusive, worldwide rights to develop, manufacture, and commercialize bardoxolone, omaveloxolone, and our next-generation Nrf2 activators, excluding certain Asian markets for bardoxolone in certain indications, which are licensed to Kyowa Kirin. Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, our plans to submit regulatory filings, and our ability to obtain and retain regulatory approval of our product candidates. You can identify forward-looking statements because they contain words such as “believes,” “will,” “may,” “aims,” “plans,” “model,” and “expects.” Forward-looking statements are based on Reata’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the timing, costs, conduct, and outcome of our clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; (ii) the timing and likelihood of regulatory filings and approvals for our product candidates; (iii) whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; (iv) the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the market opportunities for our product candidates; and (v) other factors set forth in Reata’s filings with the U.S. Securities and Exchange Commission, including the detailed factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2020. The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211028006130/en/

Reata Pharmaceuticals, Inc.

(972) 865-2219

https://reatapharma.com/

Investor Relations & Media:

Manmeet Soni

Andres Lorente

ir@reatapharma.com

media@reatapharma.com

https://reatapharma.com/contact-us/

Source: Reata Pharmaceuticals, Inc.

FAQ

What is the significance of Reata Pharmaceuticals' MAA submission for RETA stock?

The MAA submission for bardoxolone methyl may lead to regulatory approval, increasing market potential for Reata Pharmaceuticals and positively affecting RETA stock.

When is the PDUFA date for Reata Pharmaceuticals' NDA for bardoxolone?

The PDUFA date for Reata Pharmaceuticals' NDA for bardoxolone is February 25, 2022.

What condition does bardoxolone aim to treat according to Reata Pharmaceuticals' recent announcement?

Bardoxolone aims to treat chronic kidney disease (CKD) caused by Alport syndrome.

How many people are affected by Alport syndrome in the U.S.?

Alport syndrome affects approximately 30,000 to 60,000 people in the U.S.

What designations has bardoxolone received from the FDA and European Commission?

Bardoxolone has received Orphan Drug designation from the FDA for Alport syndrome and from the European Commission for the same indication.