Inebilizumab

Extended indication	Inebilizumab monotherapy for preventive treatment of immunoglobulin G4 related disease in adults and elderly at high risk of flare
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 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	No estimate possible yet
References	NCT04540497 (MITIGATE)

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.