Casirivimab/imdevimab (REGEN-COV) Authorized as COVID-19 Post-exposure Prophylaxis

Healthcare providers should be aware that on July 30, 2021, the FDA revised the emergency use authorization (EUA) for casirivimab/imdevimab (REGEN-COV) to include authorization for post-exposure prophylaxis for COVID-19. REGEN-COV also remains authorized for the treatment of 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, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Casirivimab/imdevimab (REGEN-COV) may now be used as post-exposure prophylaxis for COVID-19 in adults and pediatric individuals (12 years 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 who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), AND
o have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or
o who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons).

The data supporting the expansion of the EUA to include an indication for post-exposure prophylaxis are from a Phase 3 trial studying household contacts of individuals with SARS-CoV-2.  An 81% risk reduction in confirmed symptomatic COVID-19 cases was observed with casirivimab/imdevimab (REGEN-COV) compared to placebo in the primary analysis population.

This added indication expands the population of patients eligible for casirivimab/imdevimab (REGEN-COV).  Healthcare providers may wish to identify and refer for post-exposure prophylaxis close contacts (including household contacts) of their patients diagnosed with SARS-CoV-2 infection if those contacts meet the criteria outlined above.

Healthcare providers are also reminded that casirivimab/imdevimab (REGEN-COV) can be administered by subcutaneous injection when intravenous infusion is not feasible and would lead to delay in treatment.

Resources

Department of Health and Human Services (HHS), Federal Response to COVID-19: Monoclonal Antibody Playbook: https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Documents/USG-COVID19-Tx-Playbook.pdf

HHS Therapeutics Locator (map of locations that have received a distribution of monoclonal antibody therapeutics): https://protect-public.hhs.gov/pages/therapeutics-distribution

O’Brien, et al. (2021). Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. New England Journal of Medicine, https://www.nejm.org/doi/full/10.1056/NEJMoa2109682

Ordering information for casirivimab/imdevimab (REGEN-COV) from the drug’s sole distributor AmerisourceBergen, Inc: https://app.smartsheet.com/b/form/255d164d67834793b4ab549e160941e8

Updated Fact Sheet for Healthcare Providers on Emergency Use Authorization (EUA) of REGEN-COV (casirivimab/indevimab): https://www.fda.gov/media/145611/download