The US Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron Pharmaceuticals Inc’s COVID-19 antibody therapy, an experimental treatment administered to US President Donald Trump, which said which helped cure him of the disease.
“Licensing these monoclonal antibody therapies can help outpatients avoid hospitalization and ease the burden on our health care system,” said Stephen Hahn, Commissioner of the Food and Drug Administration.
The treatment is carried out by the American biotechnology company Regeneron Pharmaceuticals Inc. and uses casirivimab and imdevimab to administer them together.
The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be given together for the treatment of mild to moderate COVID-19 in adult and pediatric patients with positive direct viral test results for SARS-CoV-2 and who are at high risk. of progression. 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 who require oxygen therapy due to COVID-19. No benefit of casirivimab and imdevimab treatment has been demonstrated in hospitalized patients due to COVID-19.
“In a clinical trial of COVID-19 patients, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk of disease progression within 28 days after treatment compared to placebo. “said the FDA.
“The safety and efficacy of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.”
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