Reata Pharmaceuticals Completes Rolling Submission of New Drug Application for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia
March 31 2022 - 4:55PM
Business Wire
If Approved, Omaveloxolone Would Become the First Therapy
Indicated for the Treatment of Patients with Friedreich’s
Ataxia
Friedreich’s Ataxia Affects Approximately 5,000 Patients in
the United States with an Estimated 4,000 Diagnosed
Patients
Reata Pharmaceuticals, Inc. (Nasdaq: RETA), (“Reata,” the
“Company,” “our,” “us,” or “we”), a clinical-stage
biopharmaceutical company, today announced the completion of the
rolling submission of a New Drug Application (“NDA”) to the U.S.
Food and Drug Administration (“FDA”) for omaveloxolone for the
treatment of patients with Friedreich’s ataxia. This NDA is
supported by the efficacy and safety data from the MOXIe Part 1,
Part 2, and MOXIe Extension studies. The FDA has granted Fast Track
Designation and Orphan Drug Designation to omaveloxolone for the
treatment of Friedreich’s ataxia.
“This NDA submission marks an important step toward making a
treatment available for patients with Friedreich’s ataxia, a
serious degenerative neuromuscular disorder with no approved
therapies,” said Warren Huff, Reata’s Chief Executive Officer. “I
want to thank all those who made this possible, especially our
patients with Friedreich’s ataxia, their families, and
investigators, as well as our employees, for their tenacity and
unwavering belief in the omaveloxolone clinical program. We look
forward to the next steps on the path to making omaveloxolone
available as a first-in-class therapy for Friedreich’s ataxia,
pending approval.”
About Friedreich's Ataxia
Friedreich’s ataxia is a rare, genetic, life-shortening,
debilitating, and degenerative neuromuscular disorder typically
caused by a trinucleotide repeat expansion in the first intron of
the frataxin gene, which encodes the mitochondrial protein
frataxin. Pathogenic repeat expansions can lead to impaired
transcription and reduced frataxin expression, which can result in
mitochondrial iron overload and poor cellular iron regulation,
increased sensitivity to oxidative stress, and impaired
mitochondrial ATP production. Patients with Friedreich’s ataxia
typically experience symptoms in childhood, including progressive
loss of coordination, muscle weakness, and fatigue that commonly
results in motor incapacitation with patients requiring a
wheelchair in their teens or early 20s. Patients with Friedreich’s
ataxia may also experience visual impairment, hearing loss,
diabetes, and cardiomyopathy. On average, patients with
Friedreich’s ataxia die in the mid-thirties. Based on literature
and proprietary research, we believe Friedreich’s ataxia affects
approximately 5,000 children and adults in the United States and
22,000 individuals globally. There are an estimated 4,000 patients
diagnosed with FA in the United States. Currently, there are no
approved therapies for the treatment of Friedreich’s ataxia.
About Omaveloxolone
Omaveloxolone is an investigational, oral, once-daily, 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 and
Fast Track Designations to omaveloxolone for the treatment of
Friedreich’s ataxia. The European Commission has granted Orphan
Drug Designation in Europe to omaveloxolone for the treatment of
Friedreich’s ataxia.
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 methyl (“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, 2021,
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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version on businesswire.com: https://www.businesswire.com/news/home/20220331006004/en/
Reata Pharmaceuticals, Inc. (972) 865-2219
https://www.reatapharma.com/
Investor Relations & Media Relations: Andres Lorente
ir@reatapharma.com Wendy Segal media@reatapharma.com
https://www.reatapharma.com/contact-us/
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