July 30, 2021
The U.S. FDA has updated emergency use authorization (EUA) for Regeneron’s REGEN- COV™ (casirivimab and imdevimab). The monoclonal antibody combination can now be used for post- exposure prophylaxis (prevention) of COVID-19 in patients at least 12 years of age who weigh at least 40kg (88 pounds) and are at high risk for progression to severe COVID-19, including hospitalization or death.
Under the updated EUA, REGEN-COV should only be used for prevention of COVID-19 in individuals who are not fully vaccinated or not expected to have an adequate immune response to full vaccination, including individuals immunocompromised due to disease or immunosuppressive medications. The individual must have been exposed to someone infected with SARS-CoV-2 consistent with U.S. Centers for Disease Control and Prevention (CDC) close contact criteria, or be at high risk of exposure within an institutional setting (such as a nursing home) due to SARS-CoV-2 infection that has occurred in other individuals in that same setting.
REGEN-COV first received an EUA in November 2020. In addition to post-exposure prophylaxis, it’s also authorized to treat mild to moderate COVID-19 in patients at least 12 years old, weighing at least 40kg, with positive results of direct SARS-CoV-2 viral testing, and a high risk of progression to severe COVID-19.
The FDA has emphasized that REGEN-COV is not authorized for pre-exposure prophylaxis of COVID-19 and is not considered a substitute for COVID-19 vaccination.