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EMA launches rolling review of GSK/Vir Biotech’s mAb for early COVID-19

Rolling review supported by interim analysis of data from phase 3 COMET-ICE trial

The European Medicines Agency (EMA) has launched a rolling review of GlaxoSmithKline (GSK) and Vir Biotechnology’s SARS-CoV-2 monoclonal antibody (mAb) VIR-7831 for the early treatment of COVID-19, the companies have announced.

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.

In addition, this mAb 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 will review all data on VIR-7831 to reach a decision about whether to approve the mAb for emergency use in the early treatment of adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of developing severe disease.

The decision to initiate the rolling review is supported by an interim analysis of data from GSK/Vir’s phase 3 COMET-ICE trial, which evaluated VIR-7831 alone for the early treatment of high-risk patients with COVID-19.

Based on data from 583 patients included in the interim analysis, VIR-7831 demonstrated an 85% reduction in hospitalisations over 24 hours or deaths for those receiving the mAb compared to placebo.

GSK and Vir are also studying VIR-7831 in a number of additional trials, including the phase 2 COMET-PEAK, the planned phase 3 COMET-TAIL and COMET-STAR trials.

The mAb was also evaluated in the outpatient setting in the BLAZE-4 trial, sponsored by Eli Lilly, to assess the safety and efficacy of Lilly’s neutralising antibody bamlanivimab alone and with other antibodies, including VIR-7831, versus placebo in low-risk adults with mild-to-moderate COVID-19.

An interim analysis demonstrated that bamlanivimab plus VIR-7831 resulted in a 70% relative reduction of patients with persistently high viral load at day seven compare to placebo.

In a statement, GSK and Vir said that, along with Lilly, they are engaging with the US Food and Drug Administration for this treatment combination in early COVID-19.

GSK and Vir have a second mAb, VIR-7832, which is also 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

10th May 2021

From: Regulatory

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