Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.
Recent data from the U.S. Centers for Disease Control and Prevention’s (CDC) national genomic surveillance program show an increased frequency of SARS-CoV-2 variants that are expected to be resistant to bamlanivimab administered alone. As of mid-March 2021, approximately 20% of viruses sequenced in the U.S. were reported as variants expected to be resistant to bamlanivimab alone, increasing from approximately 5% in mid-January 2021.
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Source: U.S. Food & Drug Administration