Regeneron’s antibody cocktail REGEN-COV cuts the risk of hospitalisation or death by 70% in non-hospitalised COVID-19 patients, according to detailed phase 3 trial results.
The phase 3 trial evaluated REGEN-COV (casirivimab with imdevimab) in 4,567 high-risk outpatients with COVID-19, and studied two doses of the antibody cocktail – the currently authorised 2,400mg dose and a 1,200mg dose being reviewed by the US Food and Drug Administration (FDA).
All participants in this trial had at least one risk factor for developing severe COVID-19, including chronic lung disease, obesity, cardiovascular disease or were at least 50 years of age.
Detailed results from a phase 3 trial found that REGEN-COV significantly reduced the risk of hospitalisation or death, shortened symptom duration and reduced viral load in non-hospitalised patients with COVID-19.
“Despite increasing vaccination rates, many continue to be diagnosed with COVID-19 who could benefit from REGEN-COV due to underlying conditions like asthma or COPD that put them at higher risk for severe disease,” said Julie Philley, trial investigator.
“The phase 3 trial showed REGEN-COV helped patients avoid hospitalisation or even death while speeding up recovery time. These results add to the growing body of clinical evidence, real-world experience and strong recommendations by the [US] National Institutes of Health COVID-19 treatment guidelines that collectively underscore the urgent need to ensure all appropriate patients are treated,” she added.
Regeneron is collaborating with Swiss pharma company Roche to bolster the supply of REGEN-COV. Roche is primarily responsible for the development and distribution of the antibody cocktail outside the US, while Regeneron is mainly focused on operations for REGEN-COV in the US.
The antibody cocktail is continuing to be evaluated in both the symptomatic and asymptomatic outpatients settings, as well as for the prevention of COVID-19 and in certain hospitalised COVID-19 patient settings.
In the US, REGEN-COV is authorised for emergency use to treat patients with mild-to-moderate COVID-19 who are at high-risk of severe disease or hospitalisation.