Extended indication Treatment of Short Bowel Syndrome.
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Teduglutide
Domain Chronic immune diseases
Reason of inclusion Biosimilar BS
Main indication Bowel diseases
Extended indication Treatment of Short Bowel Syndrome.
Current proprietary name Revestive
Manufacturer Viatris
Mechanism of action Glucagon analogue
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2024
Expected Registration January 2026
Orphan drug Yes
Registration phase Registered

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information