Extended indication

Extension of indication to include the treatment of diabetes mellitus in adolescents and children ag

Therapeutic value

No estimate possible yet

Registration phase

Positive CHMP opinion

Product

Active substance

Insulin lispro

Domain

Metabolism and Endocrinology

Reason of inclusion

Indication extension

Main indication

Diabetes

Extended indication

Extension of indication to include the treatment of diabetes mellitus in adolescents and children aged 1 year and above.

Proprietary name

Lyumjev

Manufacturer

Eli Lilly

Mechanism of action

Insulin preparation

Route of administration

Subcutaneous

Therapeutical formulation

Injection

Budgetting framework

Extramural (GVS)

Additional comments
Lyumjev is een formulering van insuline lispro die citraat en treprostinil bevat. Citraat verhoogt de lokale 
vasculaire permeabiliteit en treprostinil induceert lokale vaatverwijding om versnelde absorptie van 
insuline lispro te bereiken. (1b tekst lyumjev)

Registration

Registration route

Centralised (EMA)

ATMP

No

Submission date

January 2022

Expected Registration

December 2022

Orphan drug

No

Registration phase

Positive CHMP opinion

Additional comments
Positieve CHMP opinie ontvangen 13 oktober 2022.

Therapeutic value

Therapeutic value

No estimate possible yet

Expected patient volume per year

Additional comments
Dit geneesmiddel wordt al bij kinderen van verschillende leeftijden toegepast (zie GIP-databank) het patiëntvolume dat extra zal worden behandeld door deze indicatie-uitbreiding lijkt dan ook beperkt.

Expected cost per patient per year

References
medicijnkosten.nl
Additional comments
Lyumjev junior kwikpen injvlst 100e/ml pen 3ml
prijs per pen betreft € 6,97 incl. BTW

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.