U.S. FDA Grants Emergency Use Authorization to Regeneron COVID-19 Antibody Given to Trump

Reuters reports that the U.S. Food and Drug Administration (FDA) has issued emergency use authorization for Regeneron Pharmaceuticals' COVID-19 experimental antibody therapy, a treatment administered to President Trump that he claimed helped cure him of the disease. According to the FDA, the monoclonal antibodies casirivimab and imdevimab should be administered in combination for treating mild to moderate COVID-19 in adults and children with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for severe COVID-19. This recommendation also applies to people 65 years or older or with certain chronic medical conditions. Regeneron stated that the clinical evidence from an outpatient trial suggests monoclonal antibodies such as REGEN-COV2 provide the greatest benefit when administered early after diagnosis and in persons who have not yet activated their own immune response or who have high viral load. The firm also expects to have doses of REGEN-COV2 treatment ready for about 80,000 patients by the end of November, about 200,000 patients by the first week of January, and roughly 300,000 patients by the end of January. The FDA cautioned that the antibodies are not authorized for people who are hospitalized due to COVID-19 or who require oxygen therapy because of the virus.