FDA Gives Emergency Approval for Lilly’s Anti-Omicron Antibody Treatment

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Eli Lilly’s Bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant of the SARS-CoV-2 virus. 

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A Neutralizing Antibody Effective Against Mutated SARS-CoV-2 Variants

Discovered by AbCellera and the US National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center researchers and licensed and developed by Eli Lilly, Bebtelovimab is a neutralising IgG1 monoclonal antibody (mAb), directed against the SARS-CoV-2 virus’ spike protein. It maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2. 

Bebtelovimab can now be used as an intravenous injection (175 mg/dose) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) satisfying the following conditions: 

• Those with positive results of direct SARS-CoV-2 viral testing, and
• having high risk for progression to severe COVID-19, including hospitalization or death, and
• for whom alternate COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

The data supporting this Emergency Use Authorization are primarily based on a Phase 2, randomized, clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19 who were treated with the authorized dose of bebtelovimab (175 mg) alone or together  in combination with other mAbs like bamlanivimab and etesevimab. Pseudovirus and authentic virus testing demonstrated that bebtelovimab retains full neutralizing activity against Omicron and all other known variants of interest and concern, including BA.2.

Eli Lilly has signed an agreement with the U.S. government to supply up to 600,000 doses of bebtelovimab for at least $720 million.

“With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic.” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. 

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Author

Arvind C. Shekhar