Shots:

• The US FDA has granted EUA for sotrovimab for mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progression to severe COVID-19 including hospitalization for >24hrs. or death
• The EUA is based on an interim analysis from the P-III COMET-ICE trial that demonstrated an 85% reduction in hospitalization or death. In vitro data indicate that the therapy maintains activity against all known variants- including Indian variant
• Sotrovimab will be available in the US in the coming wks. and data for the full population from the COMET-ICE trial is expected in H1’21. The companies plan to submit BLA to the FDA in H2’21

  Ref: GSK | Image: GSK