F D A Clears Covid Drug From Eli Lilly That Shows Promise Against Omicron


The federal government has ordered 600,000 doses of the monoclonal antibody treatment, which is meant for high-risk Covid patients early in their illness. With Covid treatments still in short supply in the United States, the Food and Drug Administration on Friday gave emergency authorization to a new monoclonal antibody drug that has been found in the laboratory to be potent against the Omicron variant of the coronavirus. The Biden administration said it would make the therapy immediately available to states free of charge. The authorization of the treatment, bebtelovimab, means that the United States now has four drugs available for high-risk Covid patients early in the course of their illness that have been found to neutralize the Omicron variant. While there is a greater menu of Covid pills and treatments now than at any other point in the pandemic, the drugs have been so scarce that doctors have been forced to make painful rationing decisions during the Omicron surge. The drug that the F. D. A. authorized on Friday is manufactured by Eli Lilly, which said on Thursday that it had signed a contract with the Department of Health and Human Services to provide the government with up to 600,000 courses of the treatment for at least $720 million. The company said it had already manufactured hundreds of thousands of doses and was ready to begin shipments within 24 hours. The Lilly drug has not been tested in a study that can show whether it can stave off severe disease. The F. D. A. said it should not be a preferred product and instead should be used only when alternative treatments are not “accessible or clinically appropriate.” Federal health officials have given a similar designation to a Covid pill from Merck and the Covid vaccine from Johnson & Johnson. However, there are data suggesting Eli Lilly’s drug is safe and may reduce the amount of virus that builds up in people who are sick with Covid. Like other drugs for recently diagnosed Covid patients, Lilly’s new treatment is authorized for people who are vulnerable to becoming seriously ill because they are older or have a medical condition like obesity or diabetes. People as young as 12 can be eligible. The drug is meant to be given as a quick intravenous injection by a health care provider, typically at a clinic or hospital. It must be administered within seven days of symptoms starting. Eli Lilly tested the drug in a mid-stage clinical trial before the emergence of the highly transmissible Omicron variant; the trial enrolled Delta-infected patients. Unvaccinated volunteers with an average risk of becoming seriously ill with Covid had their symptoms clear up faster when they were treated with the drug and had a lower level of virus in their bodies after five days compared with those who received a placebo, the F. D. A. said. The study also enrolled higher-risk people, some of whom were vaccinated, and examined whether the drug was safe for them.

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