Skyclarys FDA Approval History
Last updated by Judith Stewart, BPharm on March 1, 2023.
FDA Approved: Yes (First approved February 28, 2023)
Brand name: Skyclarys
Generic name: omaveloxolone
Dosage form: Capsules
Company: Reata Pharmaceuticals, Inc.
Treatment for: Friedreich’s Ataxia
Skyclarys (omaveloxolone) is an activator of Nrf2 (nuclear factor erythroid 2–related factor 2) for the treatment of Friedreich’s ataxia.
- Friedreich’s ataxia is a rare, genetic, life-shortening, debilitating, and degenerative neuromuscular disorder caused by a trinucleotide repeat expansion in the first intron of the frataxin gene, which encodes the mitochondrial protein frataxin.
- Skyclarys works by inducing molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
- Skyclarys capsules are taken orally, once daily on an empty stomach.
- Warnings and precautions associated with Skyclarys include elevation of aminotransferases, elevation of B-type natriuretic peptide (BNP), and lipid abnormalities.
- Common adverse reactions include elevated liver enzymes (AST/ALT), headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.
Development timeline for Skyclarys
| Date | Article |
|---|
| Feb 28, 2023 | Approval FDA Approves Skyclarys (omaveloxolone) for the Treatment of Friedreich’s Ataxia |
| Aug 9, 2022 | Reata Pharmaceuticals Announces Three Month Extension of the Review Period for New Drug Application for Omaveloxolone for the Treatment of Friedreich’s Ataxia |
| May 26, 2022 | Reata Pharmaceuticals Announces FDA Filing Acceptance and Priority Review Designation for the NDA for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia |
| Mar 31, 2022 | Reata Pharmaceuticals Completes Rolling Submission of New Drug Application for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia |
| Jan 31, 2022 | Reata Pharmaceuticals Initiates Rolling Submission of New Drug Application with U.S. FDA for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia |
| Nov 18, 2021 | Reata Pharmaceuticals Receives Fast Track Designation From the FDA for Omaveloxolone for the Treatment of Friedreich’s Ataxia |
| Sep 30, 2021 | Reata Pharmaceuticals Plans NDA Submission for Omaveloxolone in First Quarter of 2022 Following Completion of Pre-NDA Meeting with FDA |
| May 19, 2021 | Reata Announces that The FDA Has Asked The Company to Request a Pre-NDA Meeting for Omaveloxolone for the Treatment of Friedreich’s Ataxia |
| Mar 1, 2018 | Reata Announces Top-Line Data from the Dose-Escalation Cohorts of the Phase 2 Motor Study of Omaveloxolone in Patients With Mitochondrial Myopathies |
| Dec 11, 2017 | Reata Pharmaceuticals, Inc. Presents Interim Phase 1b Data for Omaveloxolone in the Treatment of Unresectable or Metastatic Melanoma |
| Sep 13, 2017 | Reata Pharmaceuticals, Inc. Receives Orphan Drug Designation for Omaveloxolone for the Treatment of Malignant Melanoma |
| Jun 22, 2017 | Reata Pharmaceuticals, Inc. Receives Orphan Drug Designation for Omaveloxolone for the Treatment of Friedreich’s Ataxia |
| Jun 1, 2017 | Reata Pharmaceuticals, Inc. Announces Positive Data From Part One of Moxie Trial of Omaveloxolone for Friedreich’s Ataxia |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
