The Food and Drug Administration is now permitting preventative use of the monoclonal antibody cocktail from Regeneron for certain people who have been exposed to COVID-19.
Until now, monoclonal antibodies had only been for patients who were already infected with COVID-19 and at high risk of getting very sick, to help prevent more severe illness.
This is the first preventative therapy for unvaccinated and immunocompromised people in high-risk settings, aimed at proactively warding off infection before a positive test.
This expanded use will be for people who meet several criteria: those who suspect they have been exposed to COVID-19, or are at high risk of an exposure; at high risk of getting very sick from COVID-19 due to health complications; or at high risk of getting sick due to not being fully vaccinated, or because of an inadequate response to the vaccine due to an immunocompromising condition.
With this preventative use, there will also be a new repeat dosing available for some people -- for those with "ongoing exposure" to COVID-19 for more than four weeks and who may not mount a strong immune response to the vaccine. These patients can get a slightly smaller monthly dose of the cocktail for "the duration of ongoing exposure" to help keep them protected from the virus.
This is the only COVID-19 antibody therapy available in the U.S. for both treatment and post-exposure prophylaxis. It has shown to hold up against the variants of concern, including delta. A Regeneron spokesperson told ABC News the company is continuing discussion with the FDA to evaluate even broader prevention use in immunocompromised people for “pre-exposure” situations.
-ABC News’ Sasha Pezenik