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Inebilizumab

Uplizna

Extended indication Inebilizumab monotherapy for preventive treatment of immunoglobulin G4 related disease in adults and
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Inebilizumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Rheumatism
Extended indication Inebilizumab monotherapy for preventive treatment of immunoglobulin G4 related disease in adults and elderly at high risk of flare
Proprietary name Uplizna
Manufacturer Amgen
Portfolio holder Amgen
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2024
Expected Registration October 2025
Registration phase Clinical trials
Additional remarks Verwachte registratie op basis van gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Therapeutic value

Therapeutic value No estimate possible yet
References NCT04540497 (MITIGATE)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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.