Extended indication Extension of indication to include treatment of adolescents for weight management for Wegovy.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Semaglutide
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension IND
Main indication Other metabolism and Endocrinology
Extended indication Extension of indication to include treatment of adolescents for weight management for Wegovy.
Proprietary name Wegovy
Manufacturer Novo Nordisk
Mechanism of action GLP-1 receptor agonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date September 2022
Expected Registration July 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

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

Duration of treatment Average 68 week / weeks
Frequency of administration 1 times a week
Dosage per administration 2,4 mg
References Weghuber et al 2022 NEJM
Additional remarks In combinatie met leefstijl interventie. De behandelduur was de maximale behandelduur in de studie.

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

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information