For immediate release:

Today, the US Food and Drug Administration revoked the emergency use authorization (EUA) that enabled the monoclonal antibody therapy bamlanivimab, when administered alone, which is used to treat mild to moderate COVID-19 in adults and certain pediatric patients. Based on the ongoing analysis of emerging scientific data, specifically the sustained increase in SARS-CoV-2 viral variants resistant to bamlanivimab alone, which increases the increased risk of treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer weighs the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuing an authorization were no longer met and withdrew the EUA.

On November 9, 2020, the FDA, based on the total scientific evidence available at the time, issued an EUA to Eli Lilly and Co. authorizing the essential use of bamlanivimab alone for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years and older weighing at least 40 kg) with positive results from direct SARS-CoV-2 virus tests, and what a have a high risk of progressing to severe COVID-19 and / or hospitalization. Importantly, although the FDA is now withdrawing this EUA, alternative monoclonal antibody therapies are available under the EUA, including REGEN-COV (casirivimab and imdevimab, co-administered), and bamlanivimab and etesevimab, co-administered, for the same uses as before for bamlanivimab has been approved. alone. The FDA believes that these alternative monoclonal antibody therapies remain appropriate for treating patients with COVID-19 when used according to the authorized labeling, based on the information currently available.

‘Although the risk benefit assessment for the use of bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies allowed for emergency use remain appropriate treatment choices when used according to the authorized labeling, and may help to keep high-risk patients with COVID-19 out of the hospital, ”says Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “We call on the American public to seek these therapies when needed, while still using the best available data to provide patients with safe and effective treatments during this pandemic.”

Monoclonal antibodies are laboratory-produced proteins that mimic the immune system’s ability to fight harmful pathogens such as viruses, such as SARS-CoV-2. Like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains.

The FDA has the responsibility to regularly review the applicability of an EUA, and as such, the agency will review new information related to the emergency use for the authorized products. Recent data from the US Centers for Disease Control and Prevention (CDC)’s national genomic monitoring program shows an increased frequency of SARS-CoV-2 variants that are expected to be resistant to bamlanivimab alone. As of mid-March 2021, about 20% of the viruses followed in the US were reported as variants that were expected to have resistance to bamlanivimab alone, which increased from about 5% in mid-January 2021.

Furthermore, there are currently no testing technologies available that enable healthcare providers to test individual patients on SARS-CoV-2 viral variants before starting treatment with monoclonal antibodies. Therefore, empirical treatment with monoclonal antibody therapies that are expected to work broadly against all variants across the country should be used to reduce the likelihood of treatment failure.

The FDA will continue to work closely with other federal government agencies, including the CDC and the National Institutes of Health, on overseeing variants that may affect the monoclonal antibody therapies used in emergencies. The agency remains committed to providing timely and transparent communication as additional information becomes available.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of food supply, cosmetics, nutritional supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.