The US Food and Drug Administration (FDA) revoked the emergency use permit which allowed experimental therapy of bamlanivimab monoclonal antibodies, when administered alone, 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 in viral variants of SARS-CoV-2 that are resistant to bamlanivimab alone, resulting in an increased risk of failure of treatment, the FDA 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 issuing an authorization are no longer met and has revoked the US.
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The emergency use permit had been issued on November 9, 2020 allowing Eli Lilly and Co emergency use of bamlanivimab only for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years or older weighing at least 40 kg) with positive results in direct viral tests for SARS-CoV-2, and who are at high risk of progressing to severe COVID-19 and / or hospitalization.
The FDA stressed that while it is now revoking the authorization, alternative monoclonal antibody therapies are still available, including REGEN-VOC (casirivimab and imdevimab, administered together), i bamlanivimab and etesevimab, administered together, For the same uses previously authorized by bamlanivimab alone.
The FDA considers these alternative monoclonal antibody therapies to remain appropriate for treating patients with COVID-19 when used in accordance with authorized indications, based on information currently available.