GSK and Vir Receive the US FDA’s EUA for Sotrovimab (VIR-7831) to Treat COVID-19 in Adults and Pediatric Patients

May 27, 2021 Auto Bot EUA, FDA, GSK, regulatory, sotrovimab, Vir Biotechnology, VIR-7831 0

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

Click here to­ read full press release/ article | Ref: GSK | Image: The Economic Times

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