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Dulaglutide

Trulicity

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.