Anti-SARS-CoV-2 Monoclonal Antibody Products Authorized in the USA

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 virus infection who are at high risk for progressing to severe disease and/or hospitalization, reported the U.S. NIH on August 4, 2021.

'The strength of the evidence for using anti-SARS-CoV-2 monoclonal antibodies varies depending on the factors that place patients at high risk for progression to severe COVID-19 and/or hospitalization.'

These products are:

• REGEN-COV2 (Casirivimab plus imdevimab): These are recombinant human monoclonal antibodies that bind to non-overlapping epitopes of the spike protein RBD of SARS-CoV-2. The FDA also updated the EUA for casirivimab plus imdevimab as post-exposure prophylaxis for certain individuals at high risk of acquiring SARS-CoV-2 infection and, if infected, are at high risk of progressing to serious illness. 
• 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.

However, Bamlanivimab plus etesevimab are neutralizing monoclonal antibodies that bind to different but overlapping epitopes in the spike protein RBD of SARS-CoV-2. 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 are currently circulating in the United States have reduced susceptibility to bamlanivimab and etesevimab.

Furthermore, the issuance of a EUA does not constitute final FDA Approval.