Posted by Michael Wonder on 16 Apr 2021
FDA revokes emergency use authorisation for monoclonal antibody bamlanivimab
16 April 2021 - Alternative monoclonal antibody therapies authorised to treat patients with COVID-19 remain available.
Today, the U.S. FDA revoked the emergency use authorisation 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 on-going 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 authorised use. Therefore, the agency determined that the criteria for issuance of an authorisation are no longer met and has revoked the emergency use authorisation.
