Masitinib

Extended indication	Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole.
Therapeutic value	No judgement
Registration phase	Withdrawn

Product

Active substance	Masitinib
Domain	Neurological disorders
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 remarks	Al als diergeneesmiddel op de markt sinds 2009 voor behandeling van mast-cel tumoren (Masivet).

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Particularity	New medicine
Submission date	September 2016
Orphan drug	Yes
Registration phase	Withdrawn
Additional remarks	Negatieve opinie CHMP april 2018. Herbeoordeling gestart in april 2018. Fabrikant heeft de aanvraag tot herbeoordeling ingetrokken in mei 2018.

Therapeutic value	No judgement

Patient volume	< 1,071 Market share is generally not included unless otherwise stated.
References	GIP databank
Additional remarks	1071 gebruikers riluzole (GIP databank 2016), maximaal volume.

Patient volume

< 1,071

Market share is generally not included unless otherwise stated.

References

GIP databank

Additional remarks

1071 gebruikers riluzole (GIP databank 2016), maximaal volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.