Kaftrio

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ivacaftor / tezacaftor / elexacaftor

Authorised
This medicine is authorised for use in the European Union.

Overview

Kaftrio is a medicine used to treat patients aged 6 years and above who have cystic fibrosis, an inherited disease that has severe effects on the lungs, the digestive system and other organs.

Cystic fibrosis can be caused by various mutations (changes) in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator’ (CFTR). People have two copies of this gene, one inherited from each parent and the disease only occurs when there is a mutation in both copies.

Kaftrio is used in combination with ivacaftor  in patients whose cystic fibrosis is due to at least one F508del mutation in the CFTR gene.

Cystic fibrosis is rare, and Kaftrio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 December 2018. Further information on the orphan designation can be found here:
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3182117

Kaftrio contains the active substances ivacaftor, tezacaftor and elexacaftor.

This EPAR was last updated on 16/01/2023

Authorisation details

Product details
Name
Kaftrio
Agency product number
EMEA/H/C/005269
Active substance
  • ivacaftor
  • tezacaftor
  • elexacaftor
International non-proprietary name (INN) or common name
  • ivacaftor
  • tezacaftor
  • elexacaftor
Therapeutic area (MeSH)
Cystic Fibrosis
Anatomical therapeutic chemical (ATC) code
R07AX32
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Vertex Pharmaceuticals (Ireland) Limited
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
21/08/2020
Contact address

Unit 49, Block F2, Northwood Court, Santry
Dublin 9, D09 T665
Ireland

Product information

01/12/2022 Kaftrio - EMEA/H/C/005269 - II/0024

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other respiratory system products

Therapeutic indication

Kaftrio is 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 F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Assessment history

Changes since initial authorisation of medicine

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