EMA
approval
· 2026-08-19
EMA Authorised: Skyclarys (omaveloxolone) — Biogen Netherlands B.V.
Summary
Skyclarys (omaveloxolone) has been authorised in the EU for Friedreich ataxia.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Friedreich Ataxia. MAH: Biogen Netherlands B.V.. Decision date: 23/07/2026. Orphan medicine