EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with COVID-19. EMA is starting this review to support national authorities who may decide on the use of this medicine for COVID-19 prior to marketing authorisation.
The review will include data from a study comparing the effect of VIR-7831 with that of a dummy treatment (placebo) in patients with mild to moderate COVID-19 who were at high risk of progressing to more severe COVID-19. The preliminary results indicate that VIR-7831 reduced the risk of hospitalisation for more than 24 hours or death by 85% compared with placebo.
EMA’s human medicines committee (CHMP) will look at how well the medicine prevents hospitalisation and death in non-hospitalised COVID-19 patients who do not require oxygen supplementation. The CHMP will also consider data on the medicine’s quality and safety.
While a more comprehensive rolling review is anticipated to start ahead of a possible application for a marketing authorisation, this current review will provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine.
EMA will communicate on the outcome of this review once it concludes.