The U.S. Food and Drug Administration has dismissed the emergency use authorization (EUA) that allowed the use of investigational monoclonal antibody therapy bamlanivimab, when administered alone, for the treatment of mild-to-moderate COVID-19 in adults and some pediatric patients. 

On the basis of evaluation of emerging scientific data, particularly the sustained increase in SARS-CoV-2 variants resistant to bamlanivimab alone, leading to a heightened risk for failure of treatment, the agency has concluded that the known and potential benefits of bamlanivimab, given alone, do not appear to outweigh the known and potential risks for its authorized use. According to the FDA, the criteria for issuance of an authorization are no longer fulfilled and the agency has thus revoked the EUA… (FDA, April 16, 2021)