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Vilobelimab

Gohibic

Extended indication Gohibic is indicated for the treatment of adult patients with SARS‑CoV2‑induced acute respiratory di
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Vilobelimab
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication COVID-19
Extended indication Gohibic is indicated for the treatment of adult patients with SARS‑CoV2‑induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of Standard of Care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)).
Proprietary name Gohibic
Manufacturer InflaRx
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 January 2025
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie november 2024

Therapeutic value

Current treatment options Tocilizumab
Therapeutic value No estimate possible yet
Substantiation Het is een anti-C5a monoklonaal antilichaam dat het complementsysteem remt. Dit zou moeten zorgen voor een lagere mortaliteit bij de eindstadia van COVID-19. Hierdoor is dit geneesmiddel is in principe variantonafhankelijk. Er is op dit moment echter nog niet genoeg bewijs om een plaatsbepaling te doen (2).
Dosage per administration 800 mg
References NCT04333420 (PANAMO) (1); Expertopinie (2).

Expected patient volume per year

References Coronadashboard. Rijksoverheid (1); Expertopinie (2).
Additional remarks In 2023 waren er 857 intensive care opnames van COVID patiënten (1). Er wordt verwacht dat er mogelijk 100 patiënten behandeld zullen worden met vilobelimab (2).

Expected cost per patient per year

References Drugs.com
Additional remarks De prijs voor Vilobelimab intraveneuze oplossing (10mg/mL) is $6,350 voor 80ml. 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.