FDA Revokes Emergency Use Authorization for COVID-19 Treatment

FDA announced on April 16, 2021 that it has revoked the Emergency Use Authorization (EUA) for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19 in adults and certain pediatric patients. The decision was based on analysis of scientific data that included a look at SARS-CoV-2 variants that appear to be resistant to bamlanivimab alone. This resistance, according to FDA, resulted in an increased risk of treatment failure, and the agency determined the benefits “no longer outweigh the known and potential risks for its authorized use.” FDA had issued EUA for bamlanivimab to be administered alone to treat mild-to-moderate COVID-19 in November 2020 based on the scientific evidence that was available at the time.

“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, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”