Extended indication Extension of indication to include the use of SAXENDA for weight management in children from the age
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Liraglutide
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Metabolic diseases
Extended indication Extension of indication to include the use of SAXENDA for weight management in children from the age of 6 years to less than 12 years
Proprietary name Saxenda
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
ATMP No
Submission date August 2024
Expected Registration March 2025
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van IHSI-inschatting.

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 3 mg
References NCT04775082 (SCALE KIDS)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 1,128.00
References GIPdatabank (1)
Additional remarks In 2023 werd er per patiënt €1.128 vergoed voor het gebruik van liraglutide (1).

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.