FDA clears monoclonal antibody drug from Eli Lilly

With Covid treatments still scarce in the United States, the Food and Drug Administration on Friday granted emergency approval to a new monoclonal antibody drug that has been found in the lab to be potent against the Omicron variant of the coronavirus.

The Biden administration said it would immediately make the therapy available to states free of charge.

The approval of the treatment, bebtelovimab, means the United States now has four drugs available to high-risk Covid patients early in the course of their disease that have been found to neutralize the Omicron variant. While there is now a larger menu of Covid pills and treatments than at any other time in the pandemic, drugs have been so scarce that doctors have had to make painful rationing decisions during the Omicron wave.

The drug the FDA approved Friday was manufactured by Eli Lilly, who said Thursday 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 produced hundreds of thousands of doses and was ready to start shipping within 24 hours.

The drug Lilly has not been tested in a study that can show whether it can prevent serious disease. The FDA said it should not be a preferred product and instead should only be used 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 is data to indicate that Eli Lilly’s drug is safe and may reduce the amount of virus that accumulates in people who are sick with Covid.

Like other drugs for recently diagnosed Covid patients, Lilly’s new treatment has been approved for people who are prone to becoming seriously ill because of their age or have a medical condition such as obesity or diabetes. People from the age of 12 can qualify.

The drug is intended to be given as a rapid intravenous injection by a healthcare provider, usually in a clinic or hospital. It should be administered within seven days of the onset of symptoms.

Eli Lilly tested the drug in a mid-stage clinical trial before the highly transmissible Omicron variant emerged; the study enrolled Delta-infected patients. In unvaccinated volunteers at average risk of becoming seriously ill with Covid, their symptoms resolved more quickly when treated with the drug and had lower levels of virus in their bodies after five days compared to those given a placebo, according to the study. the FDA.

The study also included people at higher risk, some of whom had been vaccinated, and examined whether the drug was safe for them. In the company’s safety studies, the drug was found to cause rare cases of relatively mild side effects, including infusion-related reactions, itching and rash.

Updated

February 14, 2022, 10:53 a.m. ET

Drugs with monoclonal antibodies are synthetic versions of the antibodies that are generated naturally when the body fights the virus. They were widely used during last summer’s Delta Wave, especially in red states. But during the ongoing wave, the stock of the drugs in the country has been greatly reduced as two of the three approved products are ineffective against Omicron.

That left only one such treatment, made by GlaxoSmithKline, available. Biden’s administration officials have shipped about 50,000 doses per week of the Glaxo treatment to states. By buying bebtelovimab, they could double the number of people who receive monoclonal antibodies that work against Omicron.

Falling cases and a gradual increase in the supply of two new treatments intended for the same group of high-risk patients – antiviral pills from Pfizer and Merck – are also helping to reduce treatment shortages.

The coronavirus pandemic: important things to know

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Covid boosters. Data released by the Centers for Disease Control and Prevention showed that booster shots against the coronavirus lose much of their potency after about four months, adding to evidence suggesting that some Americans may need a fourth dose.

Vaccines for young children. The Food and Drug Administration said it would wait for data on the effectiveness of three doses of the Pfizer-BioNTech coronavirus vaccine in children under 5 years of age before deciding whether to approve the vaccine for that age group.

Xavier Becerra, the secretary of health and human services, announced the deal with Lilly on Thursday. He said the company would offer the government 300,000 courses in February and another 300,000 in March. The contract includes a future option for 500,000 additional doses.

Before the rise of Omicron, the country’s three authorized antibody treatments — from Eli Lilly, Regeneron and Glaxo — were found in clinical trials to greatly reduce the risk of hospitalization or death from the virus.

But when Omicron was discovered, lab research quickly showed that Eli Lilly and Regeneron’s products were ineffective against Omicron. Last month, the FDA severely restricted use of the two products and the federal government stopped shipping them to states.

Eli Lilly had developed bebtelovimab long before the rise of Omicron as part of his collaboration with the Vaccine Research Center, a division of the National Institute of Allergy and Infectious Diseases. It did this out of “fear that there might be a new, highly drug-resistant variant,” said Dr. Daniel Skovronsky, Eli Lilly’s Chief Scientific Officer, in an interview.

The company began testing the safety of bebtelovimab early last year, then produced hundreds of thousands of doses of the drug before it knew if it would be needed. More recently, the company tested the drug in lab experiments that showed it remained highly potent against Omicron.

dr. Skovronsky said the urgency of the rapidly evolving pandemic and strong lab data warrant marketing the drug before testing it in patients with Omicron.

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

This post FDA clears monoclonal antibody drug from Eli Lilly

was original published at “https://www.nytimes.com/2022/02/11/us/politics/eli-lilly-antibody-treatment-covid.html”