Extended indication Behandeling van type 1 diabetes.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Regulatoire T-cellen (TREGS)
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Diabetes
Extended indication Behandeling van type 1 diabetes.
Manufacturer PolTREG
Budgetting framework Intermural (MSZ)
Additional comments 'T1D is an example of autoimmune disease which frequency is contineously increasing in pediatric population in Europe. Yet, there is no commonly accepted treatment which could be administered to stop the progression of disease and all afected subjects develop full onset T1D. It is therefore important to go through formal path of registration and start offering the treatment which has some efficacy in this disease.'

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Er wordt veel van dit product verwacht, echter zullen de bijwerkingen niet gering zijn. Op dit moment worden de resultaten uit de klinische studies nog afgewacht.

Expected patient volume per year

Patient volume

< 80,000

Market share is generally not included unless otherwise stated.

References Gipdatabank (1); DitabetesFonds (2);
Additional comments Totaal aantal gebruikers van diabetesmiddelen in 2016 was 814.714 (1). 10% hiervan heeft diabetes type 1 dus het aantal patiënten in Nederland bedraagt ongeveer 80.000 (2).

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.