EMA launches rolling review of GSK/Vir Biotech’s mAb for early COVID-19
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
Read more: http://www.pmlive.com/pharma_news/ema_launches_rolling_review_of_gskvir_biotechs_mab_for_early_covid-19_1369663
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
Read more: http://www.pmlive.com/pharma_news/ema_launches_rolling_review_of_gskvir_biotechs_mab_for_early_covid-19_1369663
