Inolimomab

Active substance
Inolimomab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Stem cell transplants
Extended indication
Severe steroid-resistant acute graft versus host disease (GvHD)

1. Product

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).

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
Yes
Registration phase
Clinical trials

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found
References
EudraCT Number: 2007-005009-24
Additional comments
Momenteel alleen fase 3 klinische studies in Europa.

4. 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.

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

Indication extension
No
References
adisinsight

9. Other information

There is currently no futher information available.