Masitinib

Active substance Masitinib
Domain Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Multiple sclerosis
Extended indication Multiple sclerosis, primary-progressive or relapse-free secondary progressive

Product

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)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional comments Al als diergeneesmiddel op de markt sinds 2009 voor behandeling van mast-cel tumoren (Masivet). Primary completion date van de fase III klinische studie is september 2019.

Therapeutic value

Therapeutic value No judgement
Substantiation ''Results showed the primary endpoint was met, with significantly lower increases in EDSS seen in the masitinib-treated group compared to the placebo group. This treatment effect was maintained for both the PPMS and non-active SPMS subpopulations. (Higher EDSS score represent worsening disability levels.)''
Duration of treatment continuous
Frequency of administration 2 times a day
Dosage per administration 4,5 - 6 mg / kg
References NCT01433497
Additional comments Participants receive masitinib (4.5 mg/kg/day), given orally twice daily, with a dose escalation to 6 mg/kg/day after 3 months of treatment.

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.