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Inebilizumab

Uplizna

Extended indication Inebilizumab monotherapy for treatment of myasthenia gravis in adults and elderly with anti-AChR or
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Inebilizumab
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Muscular diseases other
Extended indication Inebilizumab monotherapy for treatment of myasthenia gravis in adults and elderly with anti-AChR or anti-MuSK antibody
Proprietary name Uplizna
Manufacturer Amgen
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Verwachte registratie op basis van een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2024
Expected Registration October 2025
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
References NCT04524273 (MINT)

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.