Reata Pharmaceuticals Receives Complete Response Letter From The FDA for Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome
February 25 2022 - 5:30PM
Business Wire
Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the
“Company,” or “we”), today announced that the U.S. Food and Drug
Administration (“FDA”) has issued a Complete Response Letter
(“CRL”) regarding the New Drug Application (“NDA”) for bardoxolone
methyl (“bardoxolone”) for the treatment of patients with chronic
kidney disease (“CKD”) caused by Alport syndrome.
The CRL indicates that the FDA cannot approve the NDA in its
present form. Based on its review, the FDA concluded that it does
not believe the submitted data demonstrates that bardoxolone is
effective in slowing the loss of kidney function in patients with
Alport syndrome and reducing the risk of progression to kidney
failure and has requested additional data to support the efficacy
and safety of bardoxolone. Their conclusion was based on efficacy
and safety concerns primarily set forth in the FDA’s briefing book
and discussed at the Cardiovascular and Renal Drugs Advisory
Committee meeting held on December 8, 2021.
The FDA stated that the issues could be resolved by providing
evidence of effectiveness that includes evidence from an adequate
and well-controlled study showing a clinically relevant effect on
the rate of loss of kidney function in patients with Alport
syndrome or, alternatively, an effect on a clinical outcome (i.e.,
an endpoint that captures how patients with Alport syndrome feel,
function, or survive). In addition, the FDA stated that we would
need to address whether bardoxolone has a clinically relevant
effect on the QT interval and show that the demonstrated clinical
benefits of bardoxolone outweigh its risks. The FDA welcomed
continued discussion on the details of a path forward. We plan to
work closely with the FDA to bring this important medicine to
patients in the US.
“This outcome is a significant disappointment for our company,
as well as the many patients, families, and investigators who have
participated in our development program for bardoxolone in Alport
syndrome patients. We will continue to work with the FDA to confirm
our next steps on our Alport syndrome program,” said Warren Huff,
Reata’s Chief Executive Officer.
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 and European
Commission have granted Orphan Drug designation to bardoxolone for
the treatment of Alport syndrome and autosomal dominant polycystic
kidney disease (“ADPKD”).
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 Co., Ltd. (“Kyowa Kirin”), our
licensee, 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. Additionally, bardoxolone is currently
being studied in FALCON, a Phase 3 study for the treatment of CKD
caused by ADPKD, EAGLE, an open-label, extended access trial in
patients with CKD caused by Alport syndrome who participated in the
CARDINAL trial and patients with ADPKD who participated in the
FALCON trial, and AYAME, a Phase 3 study for the treatment of
diabetic kidney disease that is being conducted by Kyowa Kirin in
Japan.
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
in the regulation of cellular metabolism and inflammation. Reata’s
two most advanced clinical candidates, omaveloxolone and
bardoxolone, target the important transcription factor Nrf2 that
promotes the resolution of inflammation by restoring mitochondrial
function, reducing oxidative stress, and inhibiting
pro-inflammatory signaling. Omaveloxolone and bardoxolone
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 its Annual
Report on Form 10-K for the fiscal year ended December 31, 2020,
under the caption “Risk Factors.” 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.
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