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

1. Product

Proprietary name
Masipro
Manufacturer
AB Science
Mechanism of action
Tyrosine kinase inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)

2. 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.

3. 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.)''
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.

4. Expected patient volume per year

There is currently nothing known about the expected patient volume.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.