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FDA Revokes EUA for a Monoclonal Antibody Treatment, Citing Its Ineffectiveness in Treating SARS-CoV-2 Variants

FDA maze of regulations

EUA revocation indicates that SARS-CoV-2 mutations are beginning to impact COVID-19 treatment efficacies

The US Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) for the monoclonal antibody drug bamlanivimab when it is administered alone. Bamlanivimab’s EUA previously allowed it to be used for the treatment of mild to moderate COVID-19 in adults and some pediatrics.

The FDA specifically cited the emergence of resistant SARS-CoV-2 variants that bamlanivimab is not effective in treating.

While the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, MD, Director of the FDAs Center for Drug Evaluation and Research. We urge the American public to seek out these therapies when needed while we continue to use the best data available to provide patients with safe and effective treatments during this pandemic.”

The revocation of the bamlanivimab EUA marks the first time since the beginning of the COVID-19 pandemic that the efficacy of a treatment has been affected by mutations in the SARS-CoV-2 virus.

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