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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.