regulatory
confidence high
sentiment positive
materiality 0.85
Mirum receives EC approval for LIVMARLI in Alagille syndrome across EU
Mirum Pharmaceuticals, Inc.
- European Commission granted marketing authorization for LIVMARLI (maralixibat) oral solution.
- Indicated for cholestatic pruritus in Alagille syndrome patients aged 2 months and older.
- First and only approved treatment for ALGS in both EU and US; ALGS affects 1 in 30,000 globally.
- Approval follows positive CHMP opinion from September 2022.
- Authorization covers all 27 EU member states for marketing.