Monoclonal Antibody for Omicron Approved

FDA issues EUA for monoclonal antibody that is effective against Omicron

(RxWiki News) The US Food and Drug Administration (FDA) has authorized a type of monoclonal antibody that appears to be effective against the Omicron variant.

The monoclonal antibody, bebtelovimab, retains activity against Omicron, the FDA said. It's one more in a list of several monoclonal antibodies the FDA has issued emergency use authorizations (EUAs) for.

The agency authorized this new monoclonal antibody for use in patients who have COVID-19, face a high risk of severe COVID-19 and are at least 12 years old.

“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 Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a 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.”

Bebtelovimab works in much the same way as other monoclonal antibodies for COVID-19. It binds to the spike protein on the virus in an attempt to neutralize it.

This and other monoclonal antibodies for COVID-19 have been tied to a lower risk of hospitalization and death from COVID-19.

The FDA pointed out that this drug has not been studied in people who are hospitalized for COVID-19 and is therefore not intended for use in such a setting.

Possible side effects of bebtelovimab included nausea, vomiting, rash, itching and reactions related to the injection site. Other monoclonal antibodies for COVID-19 have shown a risk for rare but severe reactions like hypersensitivity and anaphylaxis. The FDA noted that this suggests that these reactions could be possible with bebtelovimab, too.

Although the number of viable treatments for COVID-19 is increasing over time, the best treatment is still prevention. And health officials still recommend vaccination, boosters and masking up in public spaces as ways to lower your risk of COVID-19 infection.

Talk to your health care provider about the available treatments for COVID-19.

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Review Date: 
February 17, 2022