🇪🇺 Alyftrek in European Union

EMA authorised Alyftrek on 30 June 2025

Marketing authorisation

EMA — authorised 30 June 2025

  • Application: EMEA/H/C/006382
  • Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
  • Local brand name: Alyftrek
  • Indication: Alyftrek tablets are indicated for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (see sections 4.2 and 5.1).
  • Pathway: orphan
  • Status: approved

The European Medicines Agency (EMA) has granted marketing authorisation for Alyftrek tablets, developed by Vertex Pharmaceuticals (Ireland) Limited. Alyftrek is indicated for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This approval was granted under the orphan designation, which is reserved for medicines that treat rare diseases.

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Alyftrek in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Respiratory approved in European Union

Frequently asked questions

Is Alyftrek approved in European Union?

Yes. EMA authorised it on 30 June 2025.

Who is the marketing authorisation holder for Alyftrek in European Union?

Vertex Pharmaceuticals (Ireland) Limited holds the EU marketing authorisation.