FDA Pulls Emergency Use Authorization for Bamlanivimab

Bamlanivimab initially received an EUA on November 9, 2020 for use alone in the treatment of adults and pediatric patients (aged 12 and older and weighing at least 40kg) with mild to moderate COVID-19 who were at risk for hospitalization or progressing to severe COVID-19.

The FDA cites increased evidence of SARS-CoV-2 viral variant resistance against bamlanivimab resulting in an increased risk of treatment failure as the reason for the revocation. Given this evidence, the FDA believes that the benefits of bamlanivimab, when given alone, do not outweigh the risk.

This change does not impact combination regimens–bamlanivimab plus etesevimab and casirivimab plus imdevimab–which are still available under EUA.

“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 FDA’s Center for Drug Evaluation and Research, in a press release from the FDA.

–Audrey Amos, PharmD

Reference:

Coronavirus (COVID-19) update: FDA revokes emergency use authorization for monoclonal antibody bamlanivimab. News Release. US Food and Drug Administration. Updated April 16, 2021. Accessed April 26, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab