Ianalumab Medicine 03 June 2025 Extended indication Behandeling van volwassen patiënten met actieve (of matige-ernstige) ziekte van Sjögren. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ianalumab Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication Behandeling van volwassen patiënten met actieve (of matige-ernstige) ziekte van Sjögren. Current proprietary name Already available biosimilars / generics Proprietary name nog niet bekend Manufacturer Novartis Portfolio holder Novartis Mechanism of action Receptor antagonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise UMCG, EMC Additional remarks anti-BAFF-R mAb Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date January 2026 Expected Registration March 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Algemene immunosuppressiva (e.g., corticosteroïden) Therapeutic value No estimate possible yet 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 300mg References NCT05350072 (NEPTUNUS-1); NCT05349214 (NEPTUNUS-2) 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 Het syndroom van Sjögren komt voor bij ongeveer 40 tot 60 op de 100.000 mensen. De fabrikant geeft aan dat wellicht maar een fractie van de patiënten met orgaanbetrokkenheid in aanmerking zal komen. Expected cost per patient per year Cost References Additional remarks nog niet bekend Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks