REGEN-COV FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 6, 2021.
FDA Approved: No (Emergency Use Authorization)
Brand name: REGEN-COV
Generic name: casirivimab and imdevimab
Previous name: Regeneron antibody cocktail
Dosage form: Infusion
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: COVID-19
REGEN-COV is a combination of two monoclonal antibodies (casirivimab and imdevimab) designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
- The casirivimab and imdevimab antibody cocktail (REGEN-COV) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on November 21, 2020. Casirivimab and imdevimab injection is not FDA approved for any use.
- Casirivimab and imdevimab administered together are authorized to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing ≥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.
- On July 30, 2021, the FDA updated the EUA for REGEN-COV to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).
- Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.
- The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.
Development timeline for REGEN-COV
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
