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F.D.A. Authorizes Monoclonal Antibody Drug With Promise Against Omicron

todayFebruary 11, 2022 7

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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 says it will make the therapy immediately available to the states, free of charge. It is meant to be given intravenously by a health care provider, typically at a clinic or hospital.

The treatment, bebtelovimab, is manufactured by Eli Lilly, which said 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 is ready to begin shipments within 24 hours.

The agency said the drug should not be a preferred product and instead be used only when alternative treatments are not “accessible or clinically appropriate.”

The drug has not been tested in a study that can show whether it can stave off severe disease.

Like other drugs for Covid patients early in their course of their illness, Eli 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.

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. Volunteers at standard risk of becoming seriously ill with Covid treated with the drug had their symptoms clear up faster and had a lower level of virus in their bodies after five days than those who received a placebo, the agency said.

Monoclonal antibody drugs are synthetic versions of the antibodies generated naturally when the body fights off the virus. They were widely used during the Delta surge last summer, particularly in red states. But during the ongoing surge, the drugs have undergone rationing because most of them were ineffective against Omicron.

That left just one such treatment, made by GlaxoSmithKline, available. Biden administration officials have been shipping roughly 50,000 doses a week of the Glaxo treatment to states. The purchase of bebtelovimab will enable them to double that number.

Falling case counts and a gradual increase of supplies of two new treatments meant for the same group of high-risk patients — antiviral pills from Pfizer and Merck — are also beginning to help ease treatment shortages.

President Biden’s health secretary, Xavier Becerra, announced the deal with Lilly on Thursday. He said the company would ship the government 300,000 courses in February, and another 300,000 in March.

The contract includes a future option for 500,000 additional doses.

“We want to make sure if an American gets sick with Covid-19, they can get a treatment that works,” Mr. Becerra said.

Eli Lilly had been developing bebtelovimab long before the emergence of Omicron, but the new variant accelerated the drug’s path to market.

The company began safety testing of bebtelovimab early last year, and then manufactured hundreds of thousands of doses of the drug before knowing whether it would be needed. More recently, the company tested the drug in laboratory experiments that found that it retains a high level of activity against Omicron.

Dr. Daniel Skovronsky, Eli Lilly’s chief scientific officer, said the fast-changing pandemic and strong laboratory data justified bringing the drug to market before testing it in patients with Omicron.

“If the national strategy is every time there’s a new variant we need to do clinical trials for that variant, we’ll never have the drugs in time,” he said. “We’ll always be one variant behind.”

Original story from https://www.nytimes.com

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