FDA revokes bamlanivimab authorization
FDA said on April 16 that it is revoking the emergency use authorization (EUA) for bamlanivimab—when administered alone—to be used for treatment of mild to moderate COVID-19 in adults and certain pediatric patients.
Bamlanivimab is an investigational monoclonal antibody therapy that was granted an EUA by FDA in November 2020 to be used alone in adult and pediatric patients ages 12 years and older who weigh at least 40 kg, have positive test results for COVID-19, and are at high risk for severe COVID-19 progression.
“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,” said FDA in a press statement.
Alternative monoclonal antibody therapies remain available under EUA, including REGEN-COV (casirivimab and imdevimab, administered together), and bamlanivimab and etesevimab, administered together, for the same uses as previously authorized for bamlanivimab alone.
“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 FDA’s 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.”
By Loren Bonner, senior editor