Sotrovimab

Extended indication	Treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Sotrovimab
Domain	Infectious diseases
Reason of inclusion	New medicine (specialité)
Main indication	Viral infections other
Extended indication	Treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19.
Manufacturer	GSK
Mechanism of action	Virus inhibitor
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Sotrovimab (also known as VIR-7831 and GSK4182136) is a monoclonal antibody with activity against SARS-CoV-2, the virus that causes COVID-19. A monoclonal antibody is a type of protein that attaches to a specific structure (called an antigen). Sotrovimab is designed to attach to the spike protein of SARS-CoV-2, limiting the ability of the virus to enter the body’s cells.

Registration route	Centralised (EMA)
Type of trajectory	Accelerated assessment
Submission date	May 2021
Expected Registration	January 2022
Registration phase	Registration application pending

Current treatment options	Remdesivir
Therapeutic value	No estimate possible yet
Substantiation	Uit de resultaten van de interim-analyse bleek dat sotrovimab het risico op hospitalisatie voor meer dan 24 uur of overlijden met 85% verminderde ten opzichte van placebo: hospitalisatie voor meer dan 24 uur of overlijden kwam voor in 1% (3 out of 291) van de patiënten die sotrovimab ontvingen en 7% (21 van de 292) patiënten die placebo kregen. De potentie is er om het in te zetten als preventief middel bij patiënten die een suboptimale of afwezige respons hebben op vaccinatie ( ie ouderen/ immuun-gecompromitteerden).
References	NCT04545060

References	Zie actuele informatie hierover bij het RIVM: https://www.rivm.nl/coronavirus-covid-19/actueel

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.