Skyclarys (omaveloxolone)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- omaveloxolone
- Company
- Biogen Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Friedreich Ataxia
- CHMP opinion
- Thu 14 Dec 2023
- EU approval
- Fri 09 Feb 2024
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006084
- ATC
- N07XX25
- Official record
- www.ema.europa.eu
Indication
The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.