Monoclonal Antibody for COVID-19 Eligibility Score

Background

  • Casirivimab (REGN10933) and imdevimab (REGN10987) are both recombinant human IgG1 monoclonal antibodies manufactured by Regeneron Pharmaceuticals; this antibody cocktail is also known as REGN-COV2

  • These antibodies are investigational therapies with limited clinical data available, and they target the receptor binding domain of the spike protein of SARS-CoV-2 and are designed to block viral attachment and entry into human cells, thus neutralizing the virus

  • The issuance of an Emergency Use Authorization (EUA) is different than FDA approval

  • In determining whether to issue an EUA, the FDA evaluates the available evidence and balances any known or potential risks with any known or potential benefits of the product for use during an emergency

  • Based on the FDA’s review, the agency determined it is reasonable to believe that bamlanivimab-etesevimab may provide a benefit in treating non-hospitalized patients with mild or moderate COVID-19

Patient Eligibility

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