Infectious Disease

The FDA is lifting the EUA for bamlanivimab monotherapy as a COVID-19 treatment

April 16, 2021

1 min read

ADD SUBJECT TO EMAIL ALARMS

Receive an email when new articles are published

Please enter your email address to receive an email when new articles are published . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If you continue to have this problem, please contact customerservice@slackinc.com.

Back to Healio

The FDA has revoked emergency use of bamlanivimab monotherapy for the treatment of mild to moderate COVID-19 in adults and certain children.

The Emergency Authorization (EAU) has been withdrawn due to the continued increase in COVID-19 virus variants resistant only to bamlanivimab (Eli Lilly), which lead to treatment failure, according to an FDA-issued press release.

Last year, the FDA granted Eli Lilly an EUA for the emergency use of bamlanivimab, a monoclonal antibody, on its own. Eli Lilly has now asked the FDA to revoke the EEA because they want to focus on the combination of bamlanivimab and eesevimab.

Alternative monoclonal antibody therapies are still available for the same indication as part of the EUA. These include the combination of casirivimab (REGN10933, Regeneron Pharmaceuticals) and imdevimab (REGN10987, Regeneron Pharmaceuticals) or REGEN-COV and bamlanivimab in combination with eesevimab according to the FDA.

“While the benefit-risk assessment for the use of bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies approved for emergency use remain suitable treatment options if they are used in accordance with the approved labeling and can help to stay high. High-risk patients with COVID-19 discharged from hospital “ Patrizia Cavazzoni, MD, Director of the FDA Center for Drug Evaluation and Research said in the press release. “We urge the American public to seek out these therapies when needed, while we continue to use the best available data to provide safe and effective treatments to patients during this pandemic.”

ADD SUBJECT TO EMAIL ALARMS

Receive an email when new articles are published

Please enter your email address to receive an email when new articles are published . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If you continue to have this problem, please contact customerservice@slackinc.com.

Back to Healio

COVID-19 Resource Center

COVID-19 Resource Center

Related Articles