Extended indication COVID-19 pneumonia
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Vilobelimab
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication COVID-19
Extended indication COVID-19 pneumonia
Proprietary name Gohibic
Portfolio holder InflaRx
Mechanism of action Complement inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date August 2023
Expected Registration September 2024
Orphan drug Yes
Registration phase Registration application pending
Additional remarks NCT04333420

Therapeutic value

Therapeutic value No estimate possible yet
Dosage per administration 800mg

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References Drugs.com
Additional remarks De prijs voor Vilobelimab intraveneuze oplossing (10mg/mL) is $6,350 voor 80 milliliters. De prijs in de Verenigde Staten is vaak hoger dan in Nederland.

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.