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Monoclonal Antibodies Granted EUA for Treatment of COVID-19

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eMediNexus    10 February 2021

The U.S. Food and Drug Administration has granted an emergency use authorization (EUA) for bamlanivimab and etesevimab combination for the treatment of mild to moderate COVID-19 in adults and children, aged 12 years or above (weighing at least 40 kg), with confirmed COVID-19, having a high risk of progression to severe disease.

The authorization also includes treatment for individuals aged 65 years or older or having some chronic medical conditions. A study conducted among patients with COVID-19, having a high risk for disease progression, revealed that a single intravenous infusion of the combination antibody therapy led to a significant decline in COVID-19-associated hospitalization and death over a follow-up of 29 days, in comparison with placebo. The drugs are; however, not authorized for patients hospitalized for COVID-19 or who need oxygen therapy due to the disease… (FDA, February 9, 2021)

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