Tadekinig Alfa Medicine 03 June 2025 Extended indication Tadekinig alfa monotherapy for add-on treatment of primary monogenic IL-18 driven Haemophagocytic lymphohistiocytosis in children, adolescents and adults with NLRC4 mutation or XIAP deficiency. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tadekinig Alfa Domain Oncology Reason of inclusion New medicine (specialité) Main indication Unknown Extended indication Tadekinig alfa monotherapy for add-on treatment of primary monogenic IL-18 driven Haemophagocytic lymphohistiocytosis in children, adolescents and adults with NLRC4 mutation or XIAP deficiency. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Ab2 Portfolio holder Mechanism of action Immunosuppression Route of administration Subcutaneous Therapeutical formulation Suspension for cutaneous use Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration February 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT03113760 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