Safe and effective: this was the verdict of Phase 3 trial results for Regeneron Pharmaceuticals, Inc.’s REGEN-COV COVID-19 treatment, as published in the New England Journal of Medicine earlier this week.
That trial reportedly met both its primary and secondary endpoints, inducing significantly reduced risk of hospitalization or death for infected, high-risk, non-hospitalized patients treated with a cocktail of casirivimab and imdevimab. That cocktail, better known as REGEN-COV, is currently authorized by the U.S. Food and Drug Administration (FDA) for emergency use on those at high risk of serious consequences from COVID-19 infection.
“Results from this NEJM publication show that REGEN-COV reduced the risk of hospitalization or death by 70 percent in high-risk non-hospitalized patients infected with COVID-19,” Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said. “This peer-reviewed publication further supports the growing evidence on REGEN-COV’s critical role to improve outcomes for patients, and reduce the significant burden on their communities and healthcare systems during this COVID-19 pandemic.”
In trials, REGEN-COV has also been shown capable of preventing symptomatic infection in both uninfected and infected asymptomatic household contacts of those infected with the SARS-CoV-2 virus, treating non-hospitalized patients already infected with SARS-CoV-2 and treating patients hospitalized and on low-flow oxygen due to their COVID-19 infections. Other analyses have indicated its capabilities against major COVID-19 variants as well, including Delta, Gamma, Beta and Mu.
Funded in part by the Biomedical Advanced Research and Development Authority (BARDA), REGEN-COV is being provided for free to specific patients as part of the government’s involvement in its development. The U.S. recently agreed to purchase another 1.4 million doses of the treatment for such purposes, bringing its total acquisition to nearly 3 million doses.