Regeneron says antibody cocktail provides long-term protection from COVID-19
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Regeneron said that a single dose of its antibody cocktail REGEN-COV reduced the risk for COVID-19 by nearly 82% up to 8 months after administration in a phase 3 trial.
REGEN-COV, which contains 600 mg each of the monoclonal antibodies casirivimab and imdevimab, was authorized for emergency use by the FDA in November 2020 for the treatment of mild to moderate COVID-19 in high-risk patients. The FDA expanded the emergency use authorization in July to include post-exposure prophylaxis.
Trial results announced Monday by Regeneron showed that, compared with placebo, people who received a single dose of REGEN-COV had an 81.6% reduced risk for developing COVID-19 during a 2-to-8-month follow-up period (95% CI, 59.8%-91.6%) and an 81.5% reduced risk for developing COVID-19 at any time during the 8 months after receiving REGEN-COV (95% CI, 70.6%-88.4%).
Myron S. Cohen, MD, who leads the monoclonal antibody efforts for the NIH-sponsored COVID Prevention Network and is director of the Institute for Global Health & Infectious Diseases at the University of North Carolina at Chapel Hill, said the findings “demonstrate how a single dose of REGEN-COV can help protect people from COVID-19 for many months after administration.”
"These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines, including people who are immunocompromised,” Cohen said.
Regeneron said the data build on previously published findings in The New England Journal of Medicine, which reported a risk reduction of 81.4% in the first month.
The newly announced findings were from an 8-month follow-up that continued to compare outcomes from more than 1,600 people assigned to receive a single dose of the cocktail or placebo. In all, seven people in the treatment arm and 38 in the placebo arm developed COVID-19 within 2 to 8 months.
George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said the data “add to the increasing body of evidence supporting the use of REGEN-COV to prevent COVID-19 in uninfected individuals.”
“With infections still occurring despite widespread vaccination, the immunocompromised face an ongoing risk of encountering the virus during their daily lives,” Yancopoulos said in a statement. “We intend to rapidly share these additional data with regulatory authorities to help those in most need of protection from COVID-19.”
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