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Pitolisant

Wakix

Extended indication Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents
Therapeutic value Possible added value
Registration phase Registered

Product

Active substance Pitolisant
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Sleep disorders
Extended indication Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents and children from the age of 6 years.
Proprietary name Wakix
Manufacturer Bioprojet
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date June 2022
Expected Registration February 2023
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP opinie in januari 2023.

Therapeutic value

Therapeutic value Possible added value
Dosage per administration nog niet bekend

Expected patient volume per year

Additional remarks Nog niet bekend

Expected cost per patient per year

Cost < 5,162.00
References GIPdatabank; EPAR
Additional remarks In 2021 werd er per volwassen gebruiker €5.162 vergoedt. Bij de jonge patiënten zal de dosering lager zijn dan bij de volwassenen. Dit zal per patiënt moeten worden bepaald maar geldt hetzelfde maximum als bij de volwassenen.

Potential total cost per year

Additional remarks Nog niet bekend

Off label use

Additional remarks Nog niet bekend

Indication extension

Indication extension Yes
Additional remarks Betreft uitbreiding naar kinderen vanaf 6 jaar,

Other information

There is currently no futher information available.