New Monoclonal Antibody Drug To Fight Omicron Gets FDA EUA

The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant, as per a PR Newswire report.

Photo Insert: Eli Lilly's bebtelovimab

The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

"Today's action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research. "This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge."

The issuance of an EUA is different than an FDA approval. In determining whether to issue an 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 bebtelovimab may be effective in treating certain patients with mild or moderate COVID-19.

When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks. There are no adequate, approved and available alternative treatments to bebtelovimab.

The EUA for bebtelovimab is supported by clinical and nonclinical data. The clinical data are from a phase 2, randomized, single-dose clinical trial evaluating the efficacy of bebtelovimab alone and bebtelovimab combined with other monoclonal antibodies for treating mild to moderate COVID-19.

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