EUA of Bamlanivimab for Treatment of COVID-19 Revoked

The USFDA has 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.

Therefore, the agency determined that the criteria for issuance of authorization are no longer met and has revoked the EUA. Alternative monoclonal antibody therapies, including REGEN-COV (imdevimab and casirivimab administered together), and bamlanivimab and etesevimab administered together. Recent data from the US CDC revealed 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.

Additionally, there are currently no testing technologies available that enable health care providers to test individual patients for SARS-CoV-2 viral variants before the start of treatment with monoclonal antibodies. Therefore, empiric treatment with monoclonal antibody therapies that are expected to work broadly against all variants across the nation should be used to reduce the likelihood of treatment failure.

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