U.S. FDA Issued Second Emergency Authorization for Lilly's Bamlanivimab

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Eli Lilly and Co. on February 9, 2021, for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who test positive for the SARS-CoV-2 coronavirus and who are at high risk for progressing to severe COVID-19.

This new EUA use for bamlanivimab includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.

The FDA's statement explained 'in a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared to placebo.'

However, bamlanivimab and etesevimab are not authorized for hospitalized patients due to COVID-19 or require oxygen therapy due to COVID-19. Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19.

Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation, says the FDA.

“Today’s action, which provides another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options health care providers can use to fight this pandemic,” commented Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, in a press statement.

“The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients. As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness.” 

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Bamlanivimab and etesevimab are monoclonal antibodies specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’s attachment and entry into human cells.

Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.

Furthermore, the issuance of a EUA is different than an FDA approval.

In determining whether to issue a EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that bamlanivimab and etesevimab administered together may effectively treat certain patients with mild or moderate COVID-19. When used to treat COVID-19 for the authorized population, these antibodies' known and potential benefits outweigh the known and potential risks.

There are no adequate, approved, and available alternative treatments to bamlanivimab and etesevimab administered together for the authorized population says the FDA.

On Nov. 9, 2020, the FDA issued a EUA for a single infusion of 700 mg bamlanivimab to treat mild-to-moderate COVID-19 in adult and certain pediatric patients. While bamlanivimab and etesevimab administered together resulted in a lower risk of resistant viruses developing during treatment than bamlanivimab administered alone, both treatments are expected to benefit patients at high risk of disease progression.

At present, both 700 milligrams bamlanivimab alone as well as 700 milligrams bamlanivimab and 1,400 milligrams etesevimab administered together will be available under a EUA.

The FDA is an agency within the U.S. Department of Health and Human Services that protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.