Skyclarys
What Skyclarys is used for
The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Skyclarys
- Active substance
- omaveloxolone
- Disease area
- Friedreich Ataxia
- Medicine group
- Other nervous system drugs
- ATC code
- N07XX25
- Marketing authorisation holder
- Biogen Netherlands B.V.
- Authorised in the EU since
- 2024
Official information
In the USA
Same active substance: Skyclarys
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Skyclarys used for?
The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
What is the active substance in Skyclarys?
Skyclarys contains omaveloxolone.
Who makes Skyclarys?
The EU marketing authorisation holder is Biogen Netherlands B.V..
Is Skyclarys an orphan medicine?
Yes. Skyclarys is designated an orphan medicine in the EU, for a rare disease (Friedreich Ataxia).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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