Kaftrio
ivacaftor / tezacaftor / elexacaftor
Table of contents
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.
-
List item
Kaftrio : EPAR - Medicine overview (PDF/102.23 KB)
First published: 21/08/2020
Last updated: 28/01/2022
EMA/352917/2020 -
-
List item
Kaftrio : EPAR - Risk-management-plan summary (PDF/205.51 KB)
First published: 21/08/2020
Last updated: 09/11/2022
Authorisation details
Product details | |
---|---|
Name |
Kaftrio
|
Agency product number |
EMEA/H/C/005269
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Cystic Fibrosis
|
Anatomical therapeutic chemical (ATC) code |
R07AX32
|
Additional 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. |
Orphan |
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 |
Product information
01/12/2022 Kaftrio - EMEA/H/C/005269 - II/0024
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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
News
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 202112/11/2021
-
26/03/2021
-
26/06/2020
-
26/06/2020