The Food and Drug Administration (FDA) has revised the emergency use authorization (EUA) for the combination monoclonal antibody therapy REGEN-COV (casirivimab and imdevimab) to include postexposure prophylaxis of COVID-19. The drug combination can now be used in adults and children 12 years of age and older weighing at least 40 kg who have been exposed to COVID-19 and, if they become COVID-19 positive, are at high risk for severe disease, including hospitalization or death. REGEN-COV previously received an EUA for the treatment of mild to moderate COVID-19 in adults and children who tested positive for SARS-CoV-2.

Individuals at high risk for severe COVID-19 include older adults; pregnant women; patients who are obese; patients who have chronic kidney disease, diabetes, immunosuppressive disease or receive immunosuppressant therapy, cardiovascular disease or hypertension, chronic lung disease, sickle cell disease, neurodevelopmental disorders (such as cerebral palsy) or other conditions that create medical complexity (such as severe congenital anomalies); and patients with a medical-related technological dependence (such as tracheostomy, gastrostomy, or positive pressure ventilation not related to COVID-19).

To use REGEN-COV for COVID-19 postexposure prophylaxis, patients must also not be fully vaccinated or not be expected to mount an adequate immune response to the vaccine; meet the Centers for Disease Control and Prevention's definition of having had close contact with someone with COVID-19; or live in an institution where there is a high risk of exposure to someone diagnosed with COVID-19 (such as a nursing home or prison). REGEN-COV is not authorized for preexposure prevention and is not a substitute for vaccination against COVID-19.

To read the FDA news release regarding REGEN-COV's EUA revision, go to http://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-m.