FDA revokes EUA for MAb bamlanivimab for COVID-19

The US Food and Drug Administration on Friday 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 an authorization are no longer met and has revoked the EUA. The drug continues to be authorized for use together with etesevimab under EUA 094.