Drug company will ask FDA to expand the drug’s EUA to allow it to be given for preventive purposes in ‘appropriate populations’
MONDAY, April 12, 2021 (HealthDay News) — People living with someone who has COVID-19 appear to get powerful protection against infection when they are given the Regeneron 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, according to The New York Times.
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.”
The new data on the Regeneron antibody cocktail come 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 received an injection of the Regeneron drug were 81 percent less likely to get sick with COVID-19 compared with volunteers who received placebo, the company said.
The Regeneron antibody cocktail, a combination of two drugs designed to mimic the antibodies generated naturally when the immune system fends off the virus, 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 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.
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