Casirivimab-imdevimab, or REGN-COV2, consists of a mixture of two monoclonal antibodies, casirivimab (REGN10933) and imdevimab (REGN10987). The antibody mixture received emergency approval in the U.S. by the Food and Drug Administration (FDA) in November 2020 for the treatment of mild to moderate COVID-19 disease.
This approval is limited to individuals at least 12 years of age and at least 40 kilograms of body weight who have tested positive for SARS-CoV-2 and are at high risk of developing a severe course of the disease. This includes patients who are 65 years of age or older or have certain chronic pre-existing conditions.
Limitations of Benefit and Potential Risk in Patients with Severe COVID-19: Benefit of treatment with casirivimab and imdevimab has not been observed in patients hospitalized for COVID-19. However, treatment outcomes with casirivimab -Imdevimab may be associated with worse clinical outcomes when the antibody mixture is administered to hospitalized patients who have high oxygen flux due to COVID-19 or who require mechanical ventilation. Therefore, casirivimab and imdevimab are not approved for use in these patients.