Extended indication

Extension of indication to include treatment of type 2 diabetes mellitus (T2DM) in children and ad

Therapeutic value

No estimate possible yet

Registration phase

Registration application pending

Product

Active substance

Dulaglutide

Domain

Metabolism and Endocrinology

Reason of inclusion

Indication extension

Main indication

Diabetes

Extended indication

Extension of indication to include treatment of type 2 diabetes mellitus (T2DM) in children and adolescents aged 10 to less than 18 years

Proprietary name

Trulicity

Manufacturer

Eli Lilly

Route of administration

Intramuscular

Therapeutical formulation

Injection

Budgetting framework

Extramural (GVS)

Additional comments
GLP1-agonist

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

July 2022

Expected Registration

May 2023

Orphan drug

No

Registration phase

Registration application pending

Therapeutic value

Therapeutic value

No estimate possible yet

References
NCT02963766
Additional comments
Participants received 0,75mg/week or 1,5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1,5mg/week for 26 weeks during the study.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost

< 802.00

References
GIPdatabank
Additional comments
In 2021 werd er per volwassen gebruiker €802,20 vergoed.

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.