Casirivimab/imdevimab

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	Viral infections other
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 remarks	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 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	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

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

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.