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EMA approval · 2026-08-19

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

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Summary

Skyclarys (omaveloxolone) has been authorised in the EU for Friedreich ataxia.

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Diseases / indications

Drugs mentioned

  • SKYCLARYS (omaveloxolone)

Snippet

Status: Authorised. Therapeutic area: Friedreich Ataxia. MAH: Biogen Netherlands B.V.. Decision date: 23/07/2026. Orphan medicine