Extended indication Multiple sclerosis, primary-progressive or relapse-free secondary progressive
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Masitinib
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Multiple sclerosis
Extended indication Multiple sclerosis, primary-progressive or relapse-free secondary progressive
Proprietary name Masipro
Manufacturer AB Science
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Al als diergeneesmiddel op de markt sinds 2009 voor behandeling van mast-cel tumoren (Masivet). Voor veel indicaties ingezet maar nog nergens gergistreerd. Primary completion date van de fase III klinische studie is juli 2019.

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information