ANX-005 Medicine 03 December 2024 Extended indication Guillain-Barré Syndrome Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance ANX-005 Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Muscular diseases other Extended indication Guillain-Barré Syndrome Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Annexon Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Complement C1 inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2025 Expected Registration July 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion datum fase 3 studie in april 2024. Therapeutic value Current treatment options IVIg is de therapie van eerste keuze bij de behandeling van GBS. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Nog geen resultaten gepubliceerd. Aangezien het een eenmalige behandeling is en de prijs daarmee wellicht acceptabel kan blijven zal het potentieel IVIg kunnen gaan vervangen indien effectiviteit bevestigd wordt. Duration of treatment Frequency of administration Dosage per administration 30mg/kg of 75mg/kg References NCT04701164 (ANX005-GBS-02) Additional remarks Expected patient volume per year Patient volume < 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Richtlijnendatabase.nl Additional remarks GBS is de meest frequente oorzaak van acute spierzwakte in de westerse wereld. De incidentie in Nederland bedraagt 1.3 op de 100.000 per jaar. Dat betekent dat er in Nederland per jaar ongeveer tweehonderd mensen GBS krijgen. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks