EMA Authorised: Kalydeco (ivacaftor) — Vertex Pharmaceuticals (Ireland) Limited

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Summary

The EMA authorised Kalydeco (ivacaftor) for cystic fibrosis under accelerated assessment in the European Union. The decision date was 04/04/2025.

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Diseases / indications

• Cystic Fibrosis

Drugs mentioned

• Kalydeco (ivacaftor)

Snippet

Status: Authorised. Therapeutic area: Cystic Fibrosis. MAH: Vertex Pharmaceuticals (Ireland) Limited. Decision date: 04/04/2025. Accelerated assessment