Inolimomab Leucotac Active substance InolimomabDomain Oncology and HematologyReason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)Main indication Stem cell transplantsExtended indication Severe steroid-resistant acute graft versus host disease (GvHD) 1. Product Proprietary name LeucotacManufacturer ElsalysMechanism of action Interleukin inhibitorRoute of administration IntravenousTherapeutical formulation Intravenous dripBudgetting framework Intermural (MSZ)Additional comments Monoklonaal antilichaam gericht tegen de alpha chain van de interleukine-2 receptor (IL-2). 2. Registration Registration route Centralised (EMA)Orphan drug YesRegistration phase Clinical trials 3. Therapeutic value Therapeutic value No judgementDuration of treatment Not foundReferences EudraCT Number: 2007-005009-24Additional comments Momenteel alleen fase III klinische studies in de EU. 4. Expected patient volume per year Patient volume 75 - 150 Market share is generally not included unless otherwise stated. References Xhaard et al. Biol Blood Marrow Transplant. 2012 Mar;18(3):406-13.Additional comments 400-500 allogene stamceltransplantaties per jaar. 50% kans op acute GvHD (250). 30-60% van de patiënten wordt steroïderesistent (75-150). 5. Expected cost per patient per year There is currently nothing known about the expected cost. 6. Potential total cost per year There is currently nothing known about the possible total cost. 7. Off label use There is currently nothing known about off label use. 8. Indication extension There is currently nothing known about indication extensions. 9. Other information There is currently no futher information available.