Inebilizumab Medicine 03 December 2024 Extended indication Inebilizumab monotherapy for preventive treatment of immunoglobulin G4 related disease in adults and elderly at high risk of flare Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Inebilizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Rheumatism Extended indication Inebilizumab monotherapy for preventive treatment of immunoglobulin G4 related disease in adults and elderly at high risk of flare Current proprietary name Already available biosimilars / generics Proprietary name Uplizna Manufacturer Amgen Portfolio holder Amgen Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2024 Expected Registration October 2025 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding. 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 NCT04540497 (MITIGATE) 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