EMA Authorised: Skyclarys (omaveloxolone) — Biogen Netherlands B.V.

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Summary

The European Medicines Agency has authorised Skyclarys (omaveloxolone) for Friedreich ataxia, with Biogen Netherlands B.V. as the marketing authorisation holder…

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Diseases / indications

• Friedreich Ataxia

Drugs mentioned

• SKYCLARYS (omaveloxolone)

Snippet

Status: Authorised. Therapeutic area: Friedreich Ataxia. MAH: Biogen Netherlands B.V.. Decision date: 13/03/2026. Orphan medicine