FDA authorizes REGEN-COV for post-exposure prophylaxis
The emergency use authorization for the monoclonal antibody therapy has been expanded to include prevention for those exposed to COVID-19
By Kerri Hatt
The U.S. FDA has revised the emergency use authorization for REGEN-COV (casirivimab and imdevimab, administered together) to include authorization of REGEN-COV for emergency use as post-exposure prophylaxis for COVID-19.
REGEN-COV has been approved as post-exposure prophylaxis for adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are:
- At high risk for progression to severe COVID-19, including hospitalization or death and not fully vaccinated or not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (e.g., those taking immunosuppressive medications)
- And have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria (defined by the CDC as being within six feet of an infected person for a total of 15 minutes or more over a 24-hour period) or who are at high risk of exposure to SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (e.g., nursing homes or prisons)
REGEN-COV will remain authorized for treating mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, who are at high risk for symptom progression.
The FDA release noted that “Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible.”