U.S. FDA grants emergency use authorization to Regeneron COVID-19 antibody given to Trump

The U.S. Food and Drug Administration on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc's COVID-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped cure him of the disease. The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to 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.

The U.S. Food and Drug Administration on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc's COVID-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped cure him of the disease.

The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to 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. https://bit.ly/3kTd6fR This includes those who are 65 years of age or older or who have certain chronic medical conditions.

The agency said the antibodies are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19.

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