GlaxoSmithKline Requests Emergency Authorization from FDA for COVID-19 Antibody Drug

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  • GlaxoSmithKline and Vir Biotechnology Friday applied to the Food and Drug Administration for emergency use authorization of their COVID-19 antibody drug
  • The companies are requesting approval for use of the drug in high-risk people age 12 years and older
  • The submission is based on findings of a phase three trial of the drug, which showed that it was 85 percent effective at reducing hospitalizations or death from COVID-19 compared wth a placebo
  • The companies began trials on the drug in August as antibody therapies gained attention after they were used to treat former President Donald Trump last year
  • GSK said they will discuss with the European Medicines Agency and other global drug regulators to make the drug available for COVID-19 patients in other parts of the world