EMA
approval
· 2025-12-16
EMA Authorised: Libmeldy (atidarsagene autotemcel) — Orchard Therapeutics (Netherlands) B.V.
Summary
The European Medicines Agency authorised Libmeldy (atidarsagene autotemcel) from Orchard Therapeutics (Netherlands) B.V. for metachromatic leukodystrophy.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Leukodystrophy, Metachromatic. MAH: Orchard Therapeutics (Netherlands) B.V.. Decision date: 15/12/2025. Orphan medicine