Bexicaserin Medicine 04 December 2025 Extended indication Bexicaserin monotherapy for treatment of Seizures in children, adolescents, adults and elderly with dravet syndrome. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Bexicaserin Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Epilepsy Extended indication Bexicaserin monotherapy for treatment of Seizures in children, adolescents, adults and elderly with dravet syndrome. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Lundbeck Portfolio holder Lundbeck Mechanism of action Route of administration Oral Therapeutical formulation Solution Budgetting framework Extramural (GVS) Centre of expertise Additional remarks LP352 (bexicaserin) is an oral 5-HT2C receptor superagonist. Bexicaserin is designed to modulate GABA and suppress central hyperexcitability, which is a characteristic of seizures. It's also thought to be more effective than serotonin and doesn't affect 5-HT2A and 5-HT2B receptors, which are linked to psychiatric disorders and heart disease. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date December 2026 Expected Registration November 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Combi van valproaat, clobazam, topiramate, stiripentol, ketogeen dieet. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er loopt een fase 3 studie DEEp SEA voor Dravet patiënten. Hier is nog geen data bekend. In de fase 2 werd consistent een 60% reductie in aanvallen over de developmental epilepsy groepen gezien. Verder worden er acceptabele bijwerkingen gezien. De resultaten vanuit de fase 3 dienen afgewacht te worden om meer te zeggen over de therapeutische waarde. Duration of treatment Frequency of administration Dosage per administration References NCT06660394 Additional remarks Expected patient volume per year Patient volume 850 - 950 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: Yakub 1992. Prevalence of SCN1A-Related Dravet Syndrome among Children Reported with Seizures following Vaccination; 2: A Population-Based Ten-Year Cohort Study; Hurst 1990; Brigo et al. Cochrane Database Syst Rev. 2013 Additional remarks Incidentie 1 per 20.000 (1) tot 1 per 40.000 kinderen (2). 24% van de mensen in Nederland is onder de 20, dus ongeveer 4 miljoen (4.084.800). Het aantal kinderen met Dravet in Nederland zou dan liggen tussen de 102 en de 204. Geschat wordt dat er ongeveer 750 volwassenen met Dravet zijn in Nederland (op basis van sterfte voor de leeftijd van 50 jaar van 15% tot 20% van de patiënten). Totaal aantal patiënten in Nederland ligt dan tussen de 850 tot 950 patiënten. 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