Drug Profile
Omaveloxolone - Biogen
Alternative Names: ABT-RTA-408; RTA-408; SKYCLARYSLatest Information Update: 14 Feb 2024
Price :
$50
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At a glance
- Originator Dartmouth College; University of Texas M. D. Anderson Cancer Center
- Developer Biogen
- Class Analgesics; Anti-inflammatories; Antineoplastics; Eye disorder therapies; Neuroprotectants; Small molecules; Triterpenes
- Mechanism of Action NF E2 related factor 2 stimulants
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Friedreich's ataxia
- Phase II Mitochondrial disorders; Ocular inflammation; Ocular pain
- Phase I/II Malignant melanoma
- Preclinical Brain disorders
- Discontinued Duchenne muscular dystrophy; Non-small cell lung cancer; Radiation-induced skin damage
Most Recent Events
- 12 Feb 2024 Registered for Friedreich's ataxia (In adolescents, In adults) in European Union (PO)
- 15 Dec 2023 Biogen expects final decision from European Commission on marketing authorization for omaveloxolone in the first quarter of 2024
- 15 Dec 2023 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issues positive opinion for omaveloxolone in Friedreich’s ataxia