Elexacaftor / tezacaftor / ivacaftor

Active substance Elexacaftor / tezacaftor / ivacaftor
Domain Lung diseases
Reason of inclusion Indication extension
Main indication Cystic fibrosis
Extended indication An Extension of indication for Sarclisa to add combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Product

Proprietary name Kaftrio
Manufacturer Vertex
Mechanism of action Protein chaperone
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date September 2020
Expected Registration July 2021
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.