EMA — authorised 9 February 2024
- Application: EMEA/H/C/006084
- Marketing authorisation holder: Biogen Netherlands B.V.
- Local brand name: Skyclarys
- Indication: The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
- Pathway: orphan
- Status: approved
The European Medicines Agency (EMA) has granted marketing authorisation for Skyclarys, a medicinal product developed by Biogen Netherlands B.V. Skyclarys is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. This approval was granted under the orphan designation, which is reserved for medicines that treat rare diseases. The marketing authorisation was granted on 9 February 2024.