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Setrusumab

Extended indication Osteogenesis imperfecta
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Setrusumab
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Other metabolism and Endocrinology
Extended indication Osteogenesis imperfecta
Manufacturer Mereo
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: SOST protein inhibitor, setrusumab is een volledig gehumaniseerd monoklonaal antilichaam dat is ontworpen om sclerostine te remmen

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Primary completion date maart 2025. In de Verenigde Staten heeft het een weesstatus, in Europa nog niet.

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a month
References NCT05125809

Expected patient volume per year

Patient volume

< 1,200

Market share is generally not included unless otherwise stated.
References www.oivereniging.nl/ (1)
Additional remarks Van iedere 15.000 tot 20.000 personen heeft er één OI, dus in Nederland zijn er 800 tot 1.200 mensen met OI. Per jaar worden hier 10 tot 15 kinderen met OI geboren. OI komt bij mannen en vrouwen evenveel voor. (1)

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

Indication extension No
References Adis Insight

Other information

There is currently no futher information available.