US FDA grants emergency use authorization to Regeneron COVID-19 antibody, also consumed by Trump

On Saturday, the US Food and Drug Administration issued emergency use authorization for Regeneron Pharmaceutical Inc’s COVID-19 antibody therapy, an experimental treatment which was given to US President Donald Trump.

The FDA said the monoclonal antibodies, casirivimab and imdevimab, need to administer together for the treatment of mild for moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.


These patients are those who are older than 65 years of age or suffer from certain chronic medical conditions. This treatment is part of a class of drugs known as monoclonal antibodies, which are manufactured copies of antibodies created by the human body to fight infections.

The company said it expects to have a dose of REGEN-COV2 treatment ready for about 80,000 patients by the end of this month, about 200,00 patients by the first week of January, and approximately 300,000 patients in total by the end of January.

The FDA said the antibodies are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.