Kaftrio (ivacaftor;tezacaftor;elexacaftor)
- Region
- 🇪🇺 EU
- Active substance
- ivacaftor;tezacaftor;elexacaftor
- Company
- Vertex Pharmaceuticals (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Cystic Fibrosis
- CHMP opinion
- Thu 25 Jun 2020
- EU approval
- Fri 21 Aug 2020
- Designations
- Orphan
- Application
- EMEA/H/C/005269
- ATC
- R07AX32
- Official record
- www.ema.europa.eu
Indication
Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Kaftrio granules are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
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.