Monoclonal antibodies are lab-made proteins that mimic the immune system’s ability to fight harmful pathogens like the coronavirus. Bebtelovimab, made by Eli Lilly and Company, is a monoclonal antibody given through intravenous injection.
Bebtelovimab can be used to treat people 12 and older who have mild to moderate Covid-19 and are at high risk of a severe form of the disease or for whom other treatment options aren’t accessible or clinically appropriate. It is not authorized for hospitalized patients or those who need oxygen therapy.
Lab tests showed that the treatment seems to work against Omicron, including the BA.2 subvariant.
In a trial with people who were at a low-risk of severe illness, the treatment reduced the time someone with Covid-19 had symptoms, compared with people who did not use it. The group that got bebtelovimab also saw a reduced viral load five days after treatment.
Possible side effects of bebtelovimab include reaction at the site of the infusion, nausea and vomiting. With other monoclonal antibody treatments, scientists have noticed rare but serious events including anaphylaxis, infusion-related reactions and hypersensitivity, and these things could also happen with bebtelovimab, the FDA said.
“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”