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 remarks 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 remarks 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 remarks 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.