The United States Food and Drug Administration (FDA). has withdrawn the emergency use permit which enabled the experimental monoclonal antibody therapy bamlanivimab, when given alone, for the treatment of mild to moderate COVID-19 in adults and certain pediatric patients.
Based on its continued analysis of emerging scientific data, notably the continued increase in SARS-CoV-2 viral variants resistant to bamlanivimab alone, resulting in an increased risk of 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 associated with its authorized use. Therefore, the agency has determined that the criteria for granting an authorization are no longer met and has withdrawn the EUA.
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The emergency use permit was issued to Eli Lilly and Co. on November 9, 2020. the emergency use of bamlanivimab only for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive direct viral test results for SARS-CoV-2, and who are at risk of progression to severe COVID-19 and / or hospitalization.
The FDA noted that although it is now withdrawing the authorization, alternative monoclonal antibody therapies remain available, including REGEN-COV (casirivimab and imdevimab, administered together), Y bamlanivimab and etesevimab, given together, for the same uses previously approved for bamlanivimab alone.
The FDA believes these alternative monoclonal antibody therapies are still suitable for the treatment of COVID-19 patients when used according to authorized indications, based on the information currently available.