Regdanvimab

Extended indication	Extension of indication to include treatment as an adjunct to a healthy nutrition and physical activity counselling for weight management in adolescent patients from the age of 12 years and above with body weight above 60 kg and obesity (BMI corresponding to ≥30 kg/m2 for adults).
Therapeutic value	No estimate possible yet
Registration phase	Positive CHMP opinion

Product

Active substance	Liraglutide
Domain	Metabolism and Endocrinology
Reason of inclusion	Indication extension
Main indication	Other metabolism and Endocrinology
Extended indication	Extension of indication to include treatment as an adjunct to a healthy nutrition and physical activity counselling for weight management in adolescent patients from the age of 12 years and above with body weight above 60 kg and obesity (BMI corresponding to ≥30 kg/m2 for adults).
Proprietary name	Saxenda
Manufacturer	Novo Nordisk
Mechanism of action	GLP-1 receptor agonist
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)
Additional remarks	GLP-1 analoog

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	February 2020
Expected Registration	June 2021
Orphan drug	No
Registration phase	Positive CHMP opinion
Additional remarks	Positieve CHMP-opinie in maart 2021.

Therapeutic value	No estimate possible yet
Frequency of administration	1 times a day
References	NCT02918279

There is currently nothing known about the expected patient volume.

Cost	1,175.00
References	GIPdatabank
Additional remarks	In 2018 werd er per patiënt €1.175 vergoed voor het gebruik van liraglutide.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.