Extended indication Treatment and prevention of COVID-19.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Casirivimab/imdevimab
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Other viral infections
Extended indication Treatment and prevention of COVID-19.
Proprietary name REGEN-COV
Manufacturer Regeneron
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Casirivimab and imdevimab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the active substances are attached to the spike protein, the virus is unable to enter the body’s cells.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date March 2021
Expected Registration November 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Uit de fase 3 data blijkt dat casirivimab/imdevimab het aantal ziekenhuisopnames met 70% terugdrong in niet opgenomen patiënten met COVID-19.
Duration of treatment one-off
Frequency of administration 1 times a day
References NCT04425629

Expected patient volume per year

Additional comments De verwachting is dat deze combinatie mogelijk een plek zal krijgen als PEP/prep voor hoog risico individuen.

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.