The US Food and Drug Administration (FDA) issued, Saturday evening, an emergency use authorization (EUA) for an antibody cocktail, made by Regeneron Pharmaceuticals, that was used to treat President Donald Trump when he was diagnosed with coronavirus last month.
The FDA said in a statement that it issued an EAU for “casirivimab and imdevimab to be
administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms) 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 statement added.
It affirmed that in a clinical trial of patients with coronavirus, “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.”
For its part, Regeneron said in a separate statement that it “expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021.
Source-Kuna