Extended indication In combination with metformin in patients with type 2 diabetes mellitus.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Polyethylene glycol loxenatide
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Diabetes
Extended indication In combination with metformin in patients with type 2 diabetes mellitus.
Manufacturer Jiangsu Hengrui
Mechanism of action GLP-1 receptor agonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional comments GLP-1 Receptor Agonist Bekostiging mogelijk extramuraal conform andere glp-1 agonisten

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Verwachte indiening gebaseerd op actual primary completion date fase 3 studie in datum in 2016.

Therapeutic value

Current treatment options Andere GLP1-agonisten.
Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 1 times a week
Dosage per administration 100µg
References NCT02477969

Expected patient volume per year

References GIPdatabank
Additional comments Totale GLP-1 klasse in 2017 volgens GIP 12.919 gebruikers.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.