FDA approves a new monoclonal antibody for Covid-19 that works against the Omicron variant

The US Food and Drug Administration has approved a new monoclonal antibody treatment for Covid-19 that appears to act against the virus’s Omicron form.

Monoclonal antibodies are lab-created proteins that mimic the immune system’s ability to fight diseases such as the coronavirus. Eli Lilly and Company’s Bebtelovimab is a monoclonal antibody administered via intravenous injection.

The Department of Health and Human Services said on Thursday that it had ordered 600,000 treatment courses. The contract will be split in half with HHS receiving half in February and the rest in March. The deal also provides the opportunity to purchase an additional 500,000 courses. According to Eli Lilly, the contract is worth at least $720 million.

Bebtelovimab is a monoclonal antibody that can be used to treat persons aged 12 and up who have mild to moderate Covid-19 and are at high risk of developing a severe version of the condition, or for whom alternative treatment options aren’t available or clinically acceptable. It is not permitted for individuals in hospitals or those who require oxygen therapy.

The treatment appears to work against Omicron, including the BA.2 subvariant, according to lab studies.

When compared to persons who did not take Covid-19, the treatment reduced the time someone with Covid-19 had symptoms in a trial with people who were at a low risk of serious illness. The bebtelovimab group also had a lower viral load five days following therapy.

“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.

Reactions at the infusion site, nausea, and vomiting are all possible side effects of bebtelovimab. Scientists have detected rare but serious complications such as anaphylaxis, infusion-related responses, and hypersensitivity with previous monoclonal antibody treatments, and these things could happen with bebtelovimab, according to the FDA.

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

In January, the FDA confined the use of Regeneron’s monoclonal antibody treatment and Eli Lilly’s earlier versions of these treatments because they appeared to no longer work against the Omicron variant, which has been the dominant circulating strain for several weeks and now accounts for all new cases in the United States. Those treatments were aimed at a specific section of the virus that had altered as a result of Omicron.

Health experts are cautiously hopeful about the pandemic’s course, in part because the country now has more medicines, including as monoclonal antibodies, than it has in the past.

GlaxoSmithKline and Vir Biotechnology’s monoclonal therapy Sotrovimab is still thought to effective against the Omicron form. The US Army has agreed to pay AstraZeneca $855 million for Evusheld, an antibody cocktail that also appears to function against Omicron.