U.S. FDA authorizes new COVID-19 monoclonal antibody that works against Omicron variant

Jen Christensen



Published Friday, February 11, 2022 8:49PM EST


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The U.S. Food and Drug Administration has authorized a new monoclonal antibody treatment that seems to work against the Omicron variant of the virus that causes COVID-19.

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.

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On Thursday, the Department of Health and Human Services announced that it had purchased 600,000 treatment courses of the treatment. HHS is set to get half of the contract in February and the rest in March. The contract also includes an option to buy 500,000 more courses. The contract is worth at least US$720 million, according to Eli Lilly.

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.

“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,” Dr. Daniel Skovronsky, Lilly’s chief scientific and medical officer and president of Lilly Research Laboratories, said in a statement.

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.”

The FDA limited the use of Regeneron’s monoclonal antibody treatment and Eli Lilly’s earlier versions of these treatments in January because they no longer seemed to work against the Omicron variant, which has been the dominant circulating strain for several weeks and now accounts for all new cases in the US. Those treatments had targeted a part of the virus that had changed with Omicron.

Health experts have said they are cautiously optimistic about the pandemic’s trajectory in part because the country has access to more treatments, like monoclonal antibodies, than ever.

Sotrovimab, a monoclonal treatment made by GlaxoSmithKline and Vir Biotechnology, is still thought to work against the Omicron variant. The U.S. Army has struck an $855 million deal with AstraZeneca for Evusheld, an antibody cocktail that also seems to work against Omicron.





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