European Medicines Agency begins review of dual-action Covid-19 monoclonal antibody (VIR-7831)

The review will look at its use for the treatment of adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19, and will include interim data from the Phase III COMET-ICE trial.

SPS commentary:

The review will include data from an interim analysis of efficacy and safety data from the Phase 3 (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization.

Results of the interim analysis of the COMET-ICE study, based on data from 583 randomised patients, demonstrated an 85% (p=0.002) relative reduction in hospitalisation or death in those receiving VIR-7831 compared to placebo. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy.

Biospace Inc.