Expand all sections

Setmelanotide

Imcivree

Extended indication Treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl sy
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Setmelanotide
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Other metabolism and Endocrinology
Extended indication Treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS).
Proprietary name Imcivree
Manufacturer Rhythm
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 October 2021
Expected Registration August 2022
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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.