April 13, 2021 - People living with someone who has COVID-19 appear to get powerful protection against infection when they are given Regeneron's antibody cocktail, a new study shows.
The findings suggest that beyond preventing the worst outcomes for coronavirus infection when given early enough, the cocktail could also prevent people from getting sick in the first place, the company said Monday.
"With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus, and we are also working to understand its potential to provide ongoing protection for immunocompromised patients who may not respond well to vaccines," Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said in a statement.
In its statement, Regeneron said it would ask the U.S. Food and Drug Administration to expand the drug's emergency authorization use -- for high-risk people who already have COVID-19 but are not hospitalized -- to allow it to be given for preventive purposes in "appropriate populations."
There's "a very substantial number of people" in the United States and globally who could be a good fit to receive these drugs for preventive purposes, Dr. Myron Cohen, a University of North Carolina researcher told The New York Times. He leads monoclonal antibody efforts for the Covid Prevention Network, a U.S. National Institutes of Health-sponsored initiative that helped oversee the Regeneron trial.
"Not everyone's going to take a vaccine, no matter what we do, and not everyone's going to respond to a vaccine," Cohen noted.
The new data on Regeneron's antibody cocktail comes from a clinical trial that enrolled more than 1,500 people who lived in the same house as someone who had tested positive for the virus within the previous four days. Those who got an injection of Regeneron's drug were 81 percent less likely to get sick with COVID-19 compared to volunteers who got a placebo, the company said.
Dr. Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital who was not involved in the study, told the Times that the data were "promising" for people who have not been vaccinated. But he noted that the type of patients that would be needed to determine whether the drug should be used preventively for immunocompromised patients were not included in the trial. "I would say we don't yet know that," Gandhi said.
Regeneron's cocktail, a combination of two drugs designed to mimic the antibodies generated naturally when the immune system fends off the virus, was given to President Donald Trump after he got sick with COVID-19 last fall.
The treatment received emergency authorization last November. Doctors are using it, as well as another antibody cocktail from Eli Lilly, for high-risk COVID-19 patients, to guard against severe disease and hospitalization.
But many hospitals and clinics have not made the treatments a priority because they are time-consuming and difficult to administer, mostly because they must be given via intravenously. Regeneron plans to ask the FDA to allow its drug to be given via an injection, as it was in the latest study, which would allow it to be given more quickly and easily.