Regeneron/Roche COVID-19 Antibody Cocktail Cuts Hospitalizations and Deaths
Regeneron Pharmaceuticals’ and Roche’s antibody cocktail, REGEN-COV (casirivimab/imdevimab), reduced the risk of hospitalization or death by 70 percent in high-risk nonhospitalized COVID-19 patients in a late-stage trial, the companies have said.
The cocktail also reduced the duration of symptoms from two weeks to 10 days, according to topline results from the phase 3 study in 4,567 individuals.
George D. Yancopoulos, Regeneron’s president and chief scientific officer, said the company will submit the new phase 3 data to the FDA to support an upcoming Biologics License Application.
The FDA granted the cocktail Emergency Use Authorization in November for treatment of patients with mild-to-moderate COVID-19 symptoms at high risk of progressing to severe disease or hospitalization (DID, Nov. 24, 2020). And the European Medicines Agency’s human medicines committee recently recommended a conditional marketing authorization for REGEN-COV for COVID-19 patients who are at high risk of progressing to severe disease (DID, March 1).
REGEN-COV is also being evaluated in several other studies, including an ongoing phase 2/3 trial of hospitalized COVID-19 patients, the UK’s phase 3 RECOVERY trial evaluating potential COVID-19 treatments and a phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. ― Jason Scott