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Insulin lispro

Lyumjev

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 remarks 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 remarks Positieve CHMP opinie ontvangen 13 oktober 2022.

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

Additional remarks 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 remarks 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.