3 monoclonal products are approved for Covid-19 treatment under EUA

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9/6/2021, 8:10:26 PM


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As of September 2021,per NIH, there are three anti-SARS-CoV-2 monoclonal antibody products currently have Emergency Use Authorizations (EUAs) from the Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in nonhospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization

only two of three are currently used Due to low efficacy and potential contribution to saracov2 fitness and new mutation emergence.

  1. The distribution of bamlanivimab plus etesevimab was paused on June 25, 2021, because both the Gamma (P.1) and Beta (B.1.351) variants of concern (VoC) that are currently circulating in the United States have reduced susceptibility to bamlanivimab and etesevimab.
  2. Casirivimab plus imdevimab: These are recombinant human monoclonal antibodies that bind to nonoverlapping epitopes of the spike protein RBD of SARS-CoV-2.
  3. Sotrovimab: This monoclonal antibody was originally identified in 2003 from a SARS-CoV survivor. It targets an epitope in the RBD of the spike protein that is conserved between SARS-CoV and SARS-CoV-2. The FDA also updated the EUA for casirivimab plus imdevimab as post-exposure prophylaxis for certain individuals who are at high risk of acquiring SARS-CoV-2 infection and, if infected, are at high risk of progressing to serious illness