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Remibrutinib

Extended indication

Chronic spontaneous urticaria
Therapeutic value

No estimate possible yet
Registration phase

Clinical trials

Product

Active substance

Remibrutinib
Domain

Chronic immune diseases
Reason of inclusion

New medicine (specialité)
Main indication

Skin diseases
Extended indication

Chronic spontaneous urticaria
Manufacturer

Novartis
Portfolio holder

Novartis
Mechanism of action

Tyrosine kinase inhibitor
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Extramural (GVS)
Centre of expertise

UMCU, EMC (UCARE centres)
Additional remarks 
Highly specific inhibitor of Bruton's tyrosine kinase

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

2024
Expected Registration

October 2025
Orphan drug

No
Registration phase

Clinical trials

Therapeutic value

Current treatment options

2nd generation antihistamines (1st line), omalizumab (2nd line), cyclosporin (3rd line)
Therapeutic value

No estimate possible yet
Frequency of administration

2 times a day
Dosage per administration

25 mg
References 
NCT05032157
Additional remarks 
De eerste keuze is omalizumab. 
Remibrutinib (een BTK remmer) zal waarschijnlijk ingezet worden na falen omalizumab.

Expected patient volume per year

References 
European Journal of Dermatology. Treatment of chronic spontaneous urticaria with an inadequate response to H1-antihistamines: an expert opinion. Volume 27, numéro 1, January-February 2017.; Urticaria Farmacotherapeutische richtlijn;
Additional remarks 
De incidentie van urticaria is 5,2 per 1.000 patiënten per jaar. Ongeveer 1,8% van de bevolking heeft minstens één keer in zijn leven chronische urticaria (zo'n 300.000 personen). Dat betekent dat de klachten langer dan zes weken duren. Echter, bij 90% van de patiënten verdwijnen de klachten binnen drie maanden, 66 tot 93% van de patiënten heeft chronische spontane urticaria.

Expected cost per patient per year

Additional remarks 
Unknown

Potential total cost per year

Additional remarks 
Unknown

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.