Fenebrutinib Medicine 04 June 2026 Extended indication Relapsing MS Therapeutic value Total cost Registration phase Clinical trials Product Active substance Fenebrutinib Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Multiple sclerosis Extended indication Relapsing MS Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Roche Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options anti-CD20 therapie (ocrelizumab, ofatumumab, ublituximab en rituximab) en natalizumab en alemtuzumab (alleen iv of sc). Therapeutic value Substantiation De Fenhance 1 en 2 studies zijn beide positief ten aanzien van relapse reductie bij RMS ten opzichte van terflunomide. Mogelijk kan fenebrutinib worden beschouwd als hoog effectieve ziekte modulerende therapie bij RMS naast de huidige beschikbare hoog effectieve MS therapieen. Duration of treatment Frequency of administration 2 times a day Dosage per administration 200 mg References NCT04586010 (FENhance 1); NCT04586023 (FENhance 2) Additional remarks Expected patient volume per year Patient volume 100 - 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Hersenstichting.nl (1); ms.nl (2) Additional remarks In 2023 waren er 38.600 mensen bekend bij de huisarts met multiple sclerose (1). Bij 85% van de mensen gaat het om de relapsing vorm (2). Door de concurrentie aan middelen bij RRMS zal het verwachte marktaandeel op maximaal een paar honderd patiënten komen te liggen. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks