REGEN-COV reduces risk of symptomatic COVID-19 infections by 81 percent in Phase 3 trial
A cocktail of casirivimab and imdevimab known as REGEN-COV, produced by Regeneron Pharmaceuticals, Inc., cut the risk of symptomatic infections by 81 percent in a Phase 3 trial of more than 1,500 people, according to a new publication in the New England Journal of Medicine.
Even better, REGEN-COV reduced symptomatic infections by 93 percent after the first week and caused no toxicities amidst higher doses. It proved capable of preventing symptomatic infection even from asymptomatic household contacts, helped to treat non-hospitalized patients infected with SARS-CoV-2, and was used to treat patients hospitalized due to COVID-19, meaning it has demonstrated capabilities not only to prevent but to treat COVID-19 cases.
“This peer-reviewed NEJM publication demonstrates that REGEN-COV provides rapid and robust protection to prevent SARS-CoV-2 infection, and follows data showing that REGEN-COV maintains effectiveness against all variants of concern,” Dr. George Yancopoulos, president and Chief Scientific Officer at Regeneron, said. “Despite the increased uptake of vaccines, SARS-CoV-2 has not been eradicated. In addition, growing evidence suggests that a substantial number of individuals, such as the immunocompromised, will not respond satisfactorily to vaccines. Thus, we believe there is a significant need for complementary medicines such as REGEN-COV to help prevent the spread of SARS-CoV-2 infection, particularly in these immunocompromised patients.”
The trial of REGEN-COV was jointly run by Regeneron and the COVID-19 Prevention Trials Network (CoVPN) under the National Institute of Allergy and Infectious Diseases (NIAID). The Biomedical Advanced Research and Development Authority (BARDA) helped in part to fund both the development and manufacturing of the cocktail. In the future, though, Regeneron will work with Roche to increase global supply of REGEN-COV.
Currently, the drug cocktail is used to treat patients either already infected or in specific post-exposure treatments, yet still at high risk of serious consequences from COVID-19 infection. It’s not meant for those already hospitalized and in need of oxygen or use as a pre-exposure treatment. It is bound to such specific uses by the terms of its emergency use authorization from the U.S. Food and Drug Administration. It can only be used on those 12 years old and older who have shown positive results from direct SARS-CoV-2 viral testing.