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Glepaglutide

Extended indication Short Bowel Syndrome.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Glepaglutide
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Bowel diseases
Extended indication Short Bowel Syndrome.
Manufacturer Zealand
Mechanism of action Glucagon analogue
Route of administration Subcutaneous
Budgetting framework Extramural (GVS)
Additional remarks Glucagon-like peptide 2 stimulants.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Primary completion fase 3 studie in juli 2022.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Het vergelijkbare geneesmiddel teduglutide wordt nog niet vergoed in Nederland (wel in de meeste andere Europese landen). Glepaglutide gaat concurreren met tedaglutide binnen de groep van glucagon-like peptide-2 analogen bij SBS. De halfwaardetijd van glepaglutide (circa 50u) is vele male langer dan die van teduglutide waardoor een wekelijkse subcutane injectie mogelijk wordt in plaats van een dagelijkse. Dit is een potentieel voordeel.
Frequency of administration 2 times a week
References NCT03690206

Expected patient volume per year

Patient volume

< 300

Market share is generally not included unless otherwise stated.
References Expert opinie (1);
Additional remarks Er wordt verwacht dat er in Nederland enkele honderden patiënten met deze indicatie zijn.

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.