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Eli Lilly says monoclonal antibody cocktail cuts hospitalizations by 70% for high-risk COVID-19 patients – USA TODAY

While vaccines may help slow the COVID-19 pandemic over the next months, drug company Eli Lilly announced Tuesday that its treatments can help save lives in the meantime. 

The company’s drug bamlanivimab was authorized by the U.S. Food and Drug Administration late last year and has been used by 125,000 high-risk patients nationwide based on early-stage data suggesting it could be effective.  

The drug is a monoclonal antibody, meaning it mimics one of the natural antibodies the immune system uses to fight off the virus.

Former President Donald Trump as well as former New Jersey Gov. Chris Christie and former New York City Mayor Rudy Giuliani all received monoclonal antibodies shortly after they were diagnosed with COVID-19.

In a large, late-stage study the company unveiled Tuesday, bamlanivimab combined with another monoclonal antibody, etesevimab, was found to be extremely effective in high-risk patients diagnosed with COVID-19.

Among patients who received a placebo, 10% of those at high risk ended up in the hospital, compared to just 2% of those who received the drug cocktail – a 70% drop. Patients were diagnosed an average of four days before treatment.

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None of the 518 patients who got the cocktail died, compared to eight deaths among an equal-sized group of people with COVID-19 who received a placebo. 

The single drug and the cocktail performed equally well, said Lilly’s chief scientific officer Dr. Daniel Skovronsky, but the company is going to switch to making the combination once it receives FDA authorization.

The combination is more likely to remain effective, he said at an afternoon news conference, as the virus that causes COVID-19 evolves, leading to new variants.

Antibodies used in medicine are Y-shaped proteins that attach to problematic molecules and cells, to flag them for destruction or block their activity [3,10].

“Bamlanivimab alone is predicted to be effective against more than 99% of all strains that we see in the United States today,” he said. “Bamlanivimab plus etesevimab should take care of the rest of them.”

The company may also add a third or fourth monoclonal as needed in the future to manage any variants that escape the current two-drug combination, he said.

An earlier Lilly study also showed that bamlanivimab can reduce serious disease among nursing home residents at high risk for COVID-19 and in the early days after infection.  

In future trials, Lilly will compare its proposed treatments against this combination, Skovronsky said, rather than against a placebo. Because the combination is so effective, it would be unethical to give high-risk patients a placebo, he said. 

There are 100,000 doses of bamlanivimab available today to patients around the world and another 250,000 will become available by the end of the quarter, Skovronsky said. 

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The U.S. government has bought hundreds of thousands of doses of Lilly’s and another combination antibody from Regeneron.

But many doses remain on shelves, unused, because of the difficulties of providing the drug to patients. 

To get a benefit, people have to receive the drug within the early stages of disease – once hospitalized with COVID-19, the drug does nothing to help, a Lilly study has shown.

Patients may not learn about the drugs until it’s too late, though.

At an early stage of the disease, people are particularly contagious, and hospitals, overrun with COVID-19 patients, have had a hard time making the time and space to deliver monoclonal antibodies. The drugs are delivered via infusion, like chemotherapy, rather than through a quick injection.

Skovronsky said Lilly is trying to speed up the time it takes to deliver the infusion and has gotten it down to under 20 minutes from an hour, which should make it easier to deliver. 

Finally, several physicians’ groups, including the Infectious Disease Society of America, have not recommended the drugs in their treatment guidelines, citing a lack of definitive evidence. Skovronsky said he hopes the new data will be enough to convince doctors to recommend monoclonal antibodies to their high-risk COVID-19 patients.

The company’s future studies will focus on testing whether smaller doses can help extend the predicted supply of the two monoclonal antibodies. It won’t be easy to produce more drug, said Lilly chairman and CEO David Ricks, but the drug that is made can be stretched further if lower doses can be used.

The recent studies tested 2,800 mg of each of the two monoclonals, and earlier studies had examined doses as high as 7,000 mg. But if only 700 mg can produce nearly as much benefit, the available supply will go much further, he said.

“A dose that could spread the available supply by a factor of two, three, or four to have the maximum human impact – that’s what we need to do now,” Ricks said. 

For more information about bamlanivimab in the U.S., Lilly has set up a 24-hour support line at 1-855-545-5921. Patients and physicians can also visit covid.infusioncenter.org or the HHS Therapeutic Distribution locator to find a potential treatment location.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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