BackUS grants emergency use authorization to Regeneron covid-19 antibody given to Donald Trump
The United States granted emergency approval for a synthetic antibody therapy against Covid-19 that was notably used to treat Donald TrumpThe treatment is by US biotech company Regeneron Pharmaceuticals Inc. and uses casirivimab and imdevimab to be administered together
PremiumThe 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.
"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," said Stephen Hahn, commissioner of the Food and Drug Administration.
The treatment is by U.S. biotech company Regeneron Pharmaceuticals Inc. and uses casirivimab and imdevimab to be administered together.
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.
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.
“In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo," the FDA said.
“The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated."
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