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Mim 8

Extended indication Haemophilia A
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Mim 8
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other non-oncological hematological medications
Extended indication Haemophilia A
Manufacturer Novo Nordisk
Portfolio holder Novo Nordisk
Mechanism of action Coagulant
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks Blood coagulation factor stimulant.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks De fabrikant geeft aan registratie in 2026 te verwachten.

Therapeutic value

Current treatment options Emicizumab
Therapeutic value No estimate possible yet
Substantiation De klinische studies (FRONTIER) lopen nog.
Duration of treatment continuous
References NCT05878938 (FRONTIER 5)
Additional remarks Participants will receive Mim8 PPX once-weekly dosing (QW), once every two weeks dosing (Q2W), or once-monthly dosing s.c. injection using a prefilled fixed dose DV3407-C1 pen-injector for 26 weeks.

Expected patient volume per year

Patient volume

< 1,376

Market share is generally not included unless otherwise stated.
References Jaarreportage HemoNED 2021 (1).
Additional remarks Er zijn 1.376 patiënten bekend met hemofilie A (1). De patiëntaantallen zullen vergelijkbaar zijn met emicizumab gebruikersaantallen, maar de aantallen emicizumab gebruikers zullen mogelijk gaan stijgen. Op dit moment krijgt ongeveer 50% van de populatie emicizumab in de eerste 3 jaar na introductie. Dat zal naar verwachting doorgroeien richting 100%. De registratie-indicatie is nog niet geheel duidelijk (ernstige hemofilie, matig-ernstig?). Dit bepaalt ook het uiteindelijke patiëntvolume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.