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EMA approval · 2026-03-19

EMA Authorised: Kaftrio (ivacaftor;tezacaftor;elexacaftor) — Vertex Pharmaceuticals (Ireland) Limited

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Summary

The EMA authorised Kaftrio, a fixed-dose triple combination of ivacaftor, tezacaftor and elexacaftor, for cystic fibrosis, with orphan designation. Decision dat…

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Diseases / indications

Drugs mentioned

  • Kaftrio (elexacaftor/tezacaftor/ivacaftor)

Snippet

Status: Authorised. Therapeutic area: Cystic Fibrosis. MAH: Vertex Pharmaceuticals (Ireland) Limited. Decision date: 18/03/2026. Orphan medicine