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Friday, May 7th, 2021

FDA revokes emergency use authorization for bamlanivimab as COVID-19 treatment

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The U.S. Food and Drug Administration (FDA) revoked last week the emergency use authorization (EUA) for the sole use of the monoclonal antibody therapy bamlanivimab against COVID-19.

“Based on its ongoing 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 authorized use,” the FDA said in a statement.

This does not mean that bamlanivimab is halted from being used in conjunction with other treatments, nor that other monoclonal antibody therapies have been revoked in any way. Eli Lilly and Co. had been operating on an EUA for bamlanivimab since Nov. 9, 2020, to treat mild to moderate cases of COVID-19 in adults and pediatric patients at high risk of progressing to hospitalization or severe cases.

However, data from the U.S. Centers for Disease Control and Prevention’s (CDC) national genomic surveillance program revealed SARS-CoV-2 variants were likely to become increasingly resistant to bamlanivimab administered alone. By mid-March this year, approximately 20 percent of viruses in the United States were noted to be variants, likely with resistance to the treatment.

“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said. “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.”

Bamlanivimab stands as a warning when dealing with viruses like SARS-CoV-2 and their ability to mutate with time. The FDA is still encouraging treatment with broadly focused monoclonal antibody therapies as a means of reducing the likelihood of treatment failure for SARS-CoV-2.