Regeneron's REGEN-COV Receives FDA Emergency Use Authorization for Post-Exposure Prophylaxis of COVID-19

On July 30, the U.S. FDA updated the Emergency Use Authorization (EUA) for Regeneron’s COVID-19 neutralizing antibody combination therapy, REGEN-COV (casirivimab and imdevimab), authorizing its use for post-exposure prophylaxis in individuals at high risk of progressing to severe COVID-19. This EUA is limited to post-exposure prophylaxis and cannot be used for pre-exposure prophylaxis, which relies primarily on vaccines. REGEN-COV remains authorized for the treatment of mild to moderate COVID-19. This EUA is of significant importance for protecting high-risk populations, particularly healthcare workers.

This is the first SARS-CoV-2 neutralizing antibody authorized in the United States for both the treatment of COVID-19 patients and post-exposure prophylaxis.

The expansion of this EUA is supported by a pivotal Phase 3 clinical trial, with trial data showing that volunteers who received a single subcutaneous dose of neutralizing antibody therapy experienced an 81% reduction in the risk of developing symptomatic COVID-19.

A recent study published in *Nature* shows that the casirivimab/imdevimab combination maintains robust neutralizing activity against the Delta variant and other SARS-CoV-2 variants.

Reference Source:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-30-2021

Executive Editor: Liuli

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