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 Leukotac
Manufacturer Elsalys
Mechanism of action Interleukin inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Monoklonaal antilichaam gericht tegen de alpha chain van de interleukine-2 receptor (IL-2).

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
References EudraCT Number: 2007-005009-24.
Additional comments Momenteel alleen fase 3 klinische studies in Europa.

Expected patient volume per year

Patient volume

150

Market share is generally not included unless otherwise stated.

References EBMT database.
Additional comments Jaarlijks worden in Nederland circa 600 allogene stamceltransplantaties uitgevoerd. In naar schatting de helft van de gevallen (=300) treedt enige vorm van Graft-versus-Host-ziekte op welke behandeld wordt met steroïden. Hiervan is naar schatting 50% steroïd refractair, wat maakt dat jaarlijks in totaal 150 patiënten theoretisch in aanmerking zouden komen voor behandeling met dit geneesmiddel.

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

Indication extension No
References adisinsight

Other information

There is currently no futher information available.