Masitinib Masipro Active substance MasitinibDomain Neurological disordersReason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)Main indication Multiple sclerosisExtended indication Multiple sclerosis, primary-progressive or relapse-free secondary progressive 1. Product Proprietary name MasiproManufacturer AB ScienceMechanism of action Tyrosine kinase inhibitorRoute of administration OralTherapeutical formulation TabletBudgetting framework Extramural (GVS) 2. Registration Registration route Centralised (EMA)Submission date 2020Expected Registration 2021Orphan drug NoRegistration phase Clinical trialsAdditional 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 judgementSubstantiation ''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 dayDosage per administration 4,5 - 6 mg / kgReferences NCT01433497Additional 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.