Extended indication Treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40
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 Other viral infections
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 comments 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

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

Therapeutic value

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

Expected patient volume per year

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

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.