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EMA concludes GSK, Vir’s mAb can be used to treat high-risk COVID-19 patients

Recommendations can be used to support national advice prior to marketing authorisation

The European Medicines Agency (EMA) has issued advice for the use of GlaxoSmithKline (GSK) and Vir Biotech’s monoclonal antibody (mAb) VIR-7831 for the treatment of COVID-19.

VIR-7831, also known as sotrovimab, is a dual-action mAb with the potential to block viral entry into healthy cells and also clear infected cells, according to preclinical data.

It is designed to bind to an epitope on SARS-CoV-2 that is shared with the virus that cause SARS (SARS-CoV-1), suggesting that this epitope is ‘highly conserved’ and less likely to mutate over time.

The EMA, following the completion of its review of the mAb, has concluded that VIR-7831 can be used for the treatment of confirmed COVID-19 in adults and adolescents aged 12 years and older who are at risk of progressing to severe disease and who do not require supplemental oxygen.

The recommendations come following a review of data, including from a study evaluating the effects of VIR-7831 in adult outpatients with mild COVID-19 symptoms.

According to a planned interim analysis of this study, VIR-7831 reduced the risk of hospitalisation for more than 24 hours or death by 85% compared to placebo.

The side effects reported in the study were also found to be mild to moderate, although the EMA added that reactions related to infusions cannot be excluded and healthcare professionals are advised to monitor patients for such reactions.

The agency’s advice can be used to support national advice for European Union member states on the potential use of the mAb prior to a marketing authorisation for the treatment.

Earlier this month, the EMA announced that it had launched a rolling review of VIR-7831, based on the interim analysis of data from the phase 3 COMET-ICE trial.

GSK and Vir also have a second mAb, VIR-7832, which is being investigated as a potential COVID-19 treatment. Both VIR-7831 and -7832 are also being studied in the phase 1b/2a NHS-supported AGILE trial in the UK in adults with mild-to-moderate COVID-19.

Article by
Lucy Parsons

25th May 2021

From: Regulatory

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