U.S. FDA Authorizes Monoclonal Antibody Found Effective Against Omicron Subvariant BA.2

The U.S. Food and Drug Administration (FDA) today announced it issued an emergency use authorization (EUA) for a new monoclonal antibody (mAbs) for the treatment of COVID-19 developed by Eli Lilly & Co., bebtelovimab.

The FDA stated in a press release issued on February 11, 2022, 'Laboratory testing showed that bebtelovimab retains activity against both the omicron variant and the BA.2 omicron subvariant.'

The U.S. NIH's OpenData Portal also indicates that bebtelovimab is active against various SARS-CoV-2 virus variants, including omicron.

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 hospitalized due to COVID-19 or requiring oxygen therapy due to COVID-19.

The FDA says, 'There are no adequate, approved, and available alternative treatments to bebtelovimab.'

"Today's action makes available another mAbs that shows activity against omicron, at a time when we are seeking to further increase supply," commented Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, in the press release.

"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 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 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 mAbs outweigh the known and potential risks.

Bebtelovimab works by binding to the spike protein of the coronavirus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death.

Serious and unexpected adverse events, including hypersensitivity, anaphylaxis, and infusion-related reactions, have been observed with other SARS-CoV2 monoclonal antibodies and could occur with bebtelovimab. In addition, clinical worsening following administration of other SARS-CoV-2 mAbs treatment has been reported and therefore is possible with bebtelovimab. 

The FDA is an agency within the U.S. Department of Health and Human Services located in Maryland 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.

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