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Inolimomab

Leucotac

Extended indication Severe steroid-resistant acute graft versus host disease (GvHD)
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Inolimomab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Stem cell transplants
Extended indication Severe steroid-resistant acute graft versus host disease (GvHD)
Proprietary name Leucotac
Manufacturer Elsalys
Mechanism of action Interleukin inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Monoklonaal antilichaam gericht tegen de alpha chain van de interleukine-2 receptor (IL-2).

Registration

Registration route Centralised (EMA)
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
References EudraCT Number: 2007-005009-24
Additional remarks Momenteel alleen fase III klinische studies in de EU.

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 remarks 400-500 allogene stamceltransplantaties per jaar. 50% kans op acute GvHD (250). 30-60% van de patiënten wordt steroïderesistent (75-150).

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.