# Skyclarys (omaveloxolone)

Type: Product

Source: Biotech Intelligence Brief — https://getbiobrief.com/entity/skyclarys-omaveloxolone
Canonical HTML page: https://getbiobrief.com/entity/skyclarys-omaveloxolone

## Timeline

- **2026-07-28**: High Court grants permission for judicial review — Judge Cian Ferriter allows Emily Felix's challenge against the HSE and Minister for Health to proceed, citing arguable grounds regarding the delay.
- **2025-12**: NCPE pharmacoeconomic evaluation completed — The National Centre for Pharmacoeconomics delivers its assessment of Skyclarys' cost-effectiveness to the HSE.
- **2024-08**: HSE reimbursement application filed — Biogen submits a formal pricing and reimbursement application to the HSE to add Skyclarys to the public drug list.
- **2024-02**: European market authorisation — The European Commission grants centralised marketing authorisation for Biogen's Skyclarys (omaveloxolone) for patients over 16.
- **2010**: Diagnosis with Friedreich's ataxia — Emily Felix, then 12 years old, is diagnosed with the rare, progressive neuromuscular disease.

## Recent coverage (1 stories)

### Biogen’s Skyclarys Faces Irish Access Battle as 12 EU Nations Already Fund It
2026-08-03 15:05:46 · Sentiment: Neutral · Impact: 5/10 · Sources: 2

Biogen’s orphan drug for Friedreich’s ataxia, approved by the EMA since February 2024, remains mired in Irish reimbursement ambiguity, prompting a patient’s judicial review and highlighting the EU’s fragmented market access for novel therapies.
Full story: https://getbiobrief.com/story/biogen-skyclarys-irish-access-battle-12-eu

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