JOIN USUS FDA grants emergency approval to Regeneron Covid-19 antibody given to Trump
The US Food and Drug Administration on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc's Covid-19 antibody therapy, an experimental treatment given to US President Donald Trump that he said helped cure him of the disease.
The FDA said that 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.
This includes those who are 65 years of age or older or who have certain chronic medical conditions.
The agency said that 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 hospitalised due to Covid-19.