Lanadelumab Medicine 05 December 2023 Extended indication TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older. Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Lanadelumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older. Current proprietary name Already available biosimilars / generics Proprietary name Takhzyro Manufacturer Shire Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Lanadelumab is een potent, specifiek, volledig humaan recombinant immunoglobuline G1 (IgG1) monoclonaal antilichaam dat bindt aan actief plasma kallikreïne en de activiteit remt. Gebonden aan plasma kallikreïne blokkeert lanadelumab splitsing van high molecular weight kininogen (HMWK) en daarmee de productie van bradykinine, waardoor de vorming van angio-oedeem voorkomen kan worden. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2023 Expected Registration August 2023 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2023. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References 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