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
Leucotac
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)
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 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.