Garadacimab Medicine 03 June 2025 Extended indication ANDEMBRY is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Garadacimab Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication ANDEMBRY is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Current proprietary name Already available biosimilars / generics Proprietary name Andembry Manufacturer Cslbehring Portfolio holder Mechanism of action Other, see general comments Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Amsterdam UMC Additional remarks Monoclonale antistof gericht tegen factor XIIa Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2023 Expected Registration February 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie december 2024 Therapeutic value Current treatment options Lanadelumab (Takhzyro), uit plasma verkregen C1-esteraseremmerconcentraat (Cinryze, Berinert), Berotralstat (Orladeyo) Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 200 mg (met een oplaaddosis van 400 mg) References NCT04656418 (VANGUARD); Craig et al. Lancet. 2022; Craig et al. Lancet. 2023. Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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