Alyftrek (deutivacaftor / tezacaftor / vanzacaftor)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- deutivacaftor / tezacaftor / vanzacaftor
- Company
- Vertex Pharmaceuticals (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Cystic Fibrosis
- CHMP opinion
- Fri 25 Apr 2025
- EU approval
- Mon 30 Jun 2025
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006382
- ATC
- R07AX33
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.