Extended indication Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Masitinib
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication ALS
Extended indication Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole.
Proprietary name Alsitek
Manufacturer AB Science
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Al als diergeneesmiddel op de markt sinds 2009 voor behandeling van mast-cel tumoren (Masivet).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2022
Expected Registration September 2023
Orphan drug Yes
Registration phase Registration application pending
Additional comments Negatieve opinie CHMP april 2018. Herbeoordeling gestart in april 2018. Fabrikant heeft de aanvraag tot herbeoordeling ingetrokken in mei 2018. Opnieuw ingediend bij de EMA.

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 4,5 of 6,0 mg/kg lichaamsgewicht
References NCT03127267
Additional comments masitinib (1x daags) wordt samen gegeven met 50mg riluzole (2x daags)

Expected patient volume per year

Patient volume

< 1,280

Market share is generally not included unless otherwise stated.

References GIP databank
Additional comments 1.280 gebruikers riluzol (GIP databank 2021), maximaal 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

Indication extension Yes
Indication extensions Onderzocht in verschillende indicatiegebieden. De eerstvolgende indicatie-uitbreidingen zijn op de scan opgenomen.

Other information

There is currently no futher information available.