Friedreich Ataxia

• EMA approval · 2026-08-19
  EMA Authorised: Skyclarys (omaveloxolone) — Biogen Netherlands B.V.

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

• EMA approval · 2026-08-04
  EMA Authorised: Skyclarys (omaveloxolone) — Biogen Netherlands B.V.

  Authorisation of Skyclarys (omaveloxolone) for Friedreich ataxia by the EMA.

• EMA approval · 2026-03-13
  EMA Authorised: Skyclarys (omaveloxolone) — Biogen Netherlands B.V.

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

• FDA approval · 2024-12-20
  FDA Approved: SKYCLARYS — Supplemental Application (Biogen)

  The FDA approved a supplemental application for SKYCLARYS (omaveloxolone) submitted by Biogen.

• FDA approval · 2024-01-25
  FDA Approved: SKYCLARYS — Supplemental Application (Biogen)

  FDA approved Biogen's supplemental application for SKYCLARYS (omaveloxolone).

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• FDA approval · 2023-02-28
  FDA Approved: SKYCLARYS — Original Application (Biogen)

  FDA approved SKYCLARYS (omaveloxolone) from Biogen under Original Application NDA216718 for the treatment of Friedreich's ataxia.