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EMA approval · 2025-12-16

EMA Authorised: Libmeldy (atidarsagene autotemcel) — Orchard Therapeutics (Netherlands) B.V.

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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

  • Libmeldy (atidarsagene autotemcel)

Snippet

Status: Authorised. Therapeutic area: Leukodystrophy, Metachromatic. MAH: Orchard Therapeutics (Netherlands) B.V.. Decision date: 15/12/2025. Orphan medicine