Selinexor

Extended indication	Extension of indication to include patients from 1 month to 4 years of age for treatment of partial-onset seizures with or without secondary generalisation as monotherapy and adjunctive therapy for Vimpat/Lacosamide USB.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Lacosamide
Domain	Neurological disorders
Reason of inclusion	Indication extension
Main indication	Epilepsy
Extended indication	Extension of indication to include patients from 1 month to 4 years of age for treatment of partial-onset seizures with or without secondary generalisation as monotherapy and adjunctive therapy for Vimpat/Lacosamide USB.
Proprietary name	Vimpat
Manufacturer	UCB
Mechanism of action	Other, see general comments
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Extramural (GVS)
Additional remarks	CRMP2 protein modulator.

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	January 2021
Expected Registration	November 2021
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient 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.