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EMA approval · 2026-04-21

EMA Authorised: Ezmekly (mirdametinib) — SpringWorks Therapeutics Ireland Limited

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Summary

The European Medicines Agency authorised Ezmekly (mirdametinib) for neurofibromatosis type 1 with plexiform neurofibromas, under conditional approval and orphan…

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Diseases / indications

Drugs mentioned

  • Ezmekly (mirdametinib)

Snippet

Status: Authorised. Therapeutic area: Neurofibromatosis 1;Neurofibroma, Plexiform. MAH: SpringWorks Therapeutics Ireland Limited. Decision date: 12/03/2026. Conditional approval. Orphan medicine