Regeneron's COVID-19 antibody cocktail pads case for saving lives in hospitalized patients as FDA decision nears

REGEN-COV, a combination of casirivimab and imdevimab, reduced the risk of death by 36% over placebo at Day 29 in hospitalized COVID-19 patients who didn’t require high-flow oxygen or mechanical ventilation when entering the trial, Regeneron unveiled at IDWeek 2021. All patients also received standard-of-care treatments. Regeneron already has a request under FDA review to expand REGEN-COV’s emergency use authorization to cover hospital settings. The two-drug combo is currently authorized for treating certain outpatients and as a post-exposure prophylaxis method to prevent the development of symptomatic COVID-19 in high-risk individuals. The 36% improvement didn’t meet the statistical significance bar. An early stop of the phase 2/3 trial thanks to slow enrollment was partly to blame. The efficacy data came from nearly 1,200 patients, just over a third of the trial size originally planned.