The FDA has authorized an additional use for the COVID-19 monoclonal antibody therapeutic REGEN-COV (casirivimab and imdevimab). The REGEN-COV Emergency Use Authorization (EUA) has been expanded to include post-exposure prophylaxis. FDA’s authorization of a therapeutic product for post-exposure prophylaxis is a significant advancement in the COVID-19 response that supplements vaccination for disease prevention.

The new authorization is for post-exposure prophylaxis use:

• in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
• Not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
  • Have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per CDC or
  • Who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of COVID-19 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)

This new authorized use is in addition to the prior authorization of REGEN-COV to treat non-hospitalized patients with mild to moderate COVID-19 in adult and pediatric patients, aged 12 and older, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID 19, including hospitalization or death.

REGEN-COV is expected to be effective against circulating variants, including the Delta variant. It should be noted that post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19, and REGEN-COV is not authorized for pre-exposure prophylaxis.

For both non-hospitalized treatment and post-exposure prophylaxis use, the authorized dose is 600 mg of casirivimab and 600 mg of imdevimab. For treatment of mild to moderate COVID-19, a single intravenous infusion is strongly recommended; however, subcutaneous injection may be an alternative if infusion is not feasible or would significantly delay treatment. For post-exposure prophylaxis, REGEN-COV may be administered as either subcutaneous injection or a single IV infusion. Please refer to the updated Fact Sheets for full details about dosing and administration.

Should you have any questions regarding the expanded indication for REGEN-COV, please contact [email protected].