Insulin Icodec

Extended indication	treatment of diabetes mellitus in adults
Therapeutic value	Possible benefit in ease of use
Registration phase	Registration application pending

Product

Active substance	Insulin Icodec
Domain	Metabolism and Endocrinology
Reason of inclusion	New medicine (specialité)
Main indication	Diabetes
Extended indication	treatment of diabetes mellitus in adults
Manufacturer	Novo Nordisk
Portfolio holder	Novo Nordisk
Mechanism of action	Insulin preparation
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)
Additional remarks	Eenmaal wekelijkse dosering

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	April 2023
Expected Registration	May 2024
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	Possible benefit in ease of use
Frequency of administration	1 times a week
References	NCT04880850; NCT04848480

References	Gipdatabank
Additional remarks	In 2016 waren er 446.462 gebruikers van insuline (totaal van 12 verschillende producten).

There is currently nothing known about the expected cost.

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.