GlaxoSmithKline - Vir Biotech's Antibody COVID-19 Treatment Wins CHMP's Positive Scientific Opinion

  • The European Medicines Agency’s advisory group, Committee for Human Medicinal Products (CHMP), has concluded that GlaxoSmithKline plc GSK and Vir Biotechnology Inc VIR antibody COVID-19 treatment, sotrovimab, can be used.
  • The opinion covers confirmed COVID-19 in adults and adolescents who don’t require supplemental oxygen therapy and are at risk of progressing to severe COVID-19.
  • EMA said an interim analysis of the infusion indicated that sotrovimab reduced the risk of hospitalization for more than 24 hours or death by 85% compared with placebo.
  • Hospitalization for more than 24 hours or death occurred in 1% (3 out of 291) of patients who received sotrovimab and 7% (21 out of 292) of those who received placebo.
  • The companies also submitted an emergency use authorization application for the mAb to the FDA, and Health Canada is also reviewing it.
  • Price Action: VIR shares are down 0.09% at $45.11, and GSK stock is down 0.40% at 38.87 during the market session on the last check Friday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 VaccineEuropean Medicines Agency (EMA)
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