Olutasidenib

Extended indication	Treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Insulin icodec / semaglutide
Domain	Metabolism and Endocrinology
Reason of inclusion	New medicine (specialité)
Main indication	Diabetes
Extended indication	Treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists
Proprietary name	IcoSema
Manufacturer	Novo Nordisk
Mechanism of action	Insulin preparation
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	November 2024
Expected Registration	December 2025
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	Verwachte registratie op basis van gemiddelde doorlooptijd van 13 maanden voor nieuw middel.

Therapeutic value	No estimate possible yet
Frequency of administration	1 times a week
References	NCT05352815 (COMBINE 1); NCT05259033 (COMBINE 2); NCT05013229 (COMBINE 3)
Additional remarks	IcoSema is een fixed-ratio combinatie van wekelijks basaal insuline icodec en wekelijks semaglutide (700U/2 mg/ml). IcoSema wordt op dezelfde manier getitreerd als insuline, met een maximale wekelijkse dosering van 350 doseringsstappen (i.e., 350 U insuline icodec/1 mg semaglutide).

References	GIPdatabank (1)
Additional remarks	In Nederland zijn er ongeveer 195.000 gebruikers van langwerkende insulines (1).

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.