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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.