FDA rescinds EUA for bamlanivimab monotherapy as COVID-19 treatment
The FDA has rescinded the emergency use authorization for bamlanivimab monotherapy for the treatment of mild-to-moderate COVID-19 in adults and certain children.
The emergency use authorization (EAU) has been revoked because of the sustained increase in COVID-19 viral variants that are resistant to bamlanivimab (Eli Lilly) alone, resulting in treatment failure, according to an FDA-issued press release.
Last year, the FDA issued an EUA to Eli Lilly for the emergency use of bamlanivimab, a monoclonal antibody, alone. Eli Lilly has now requested the FDA to revoke the EUA because they want to focus on the combination of bamlanivimab and etesevimab.
Alternative monoclonal antibody therapies remain available under EUA for this same indication. These include the combination of casirivimab (REGN10933, Regeneron Pharmaceuticals) and imdevimab (REGN10987, Regeneron Pharmaceuticals), or REGEN-COV, and bamlanivimab combined with etesevimab, according to the FDA.
“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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the 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.”