- Eli Lilly will supply the U.S. government with 600,000 doses of its new COVID-19 treatment following the Food and Drug Administration's decision Friday to authorize it for emergency use. Discovered by Lilly's partner AbCellera, the drug has appeared effective in laboratory testing against all known coronavirus variants of concern, including omicron and the sub-strain known as BA.2.
- The U.S. will pay Lilly at least $720 million for the supply, equaling a price of $1,200 per dose, for delivery no later than March 31, the company announced Friday. The contract calls for an option to add another 500,000 by July 31. U.S. patients will have no out-of-pocket costs for treatment with the drug, called bebtolivimab.
- The agreement comes after the FDA placed strict limitations on the use of several similar drugs, including Lilly's bamlanivimab and etesivimab, because they lack effectiveness against omicron. Expansion in bebtolivimab's availability would give doctors another treatment option beyond Vir Biotechnology's sotrovimab, Gilead's Veklury, Pfizer's Paxlovid and Merck & Co.'s molnupiravir.
As the pandemic has gone on, the coronavirus evolved in ways that have made some drugs ineffective and reduced the protection offered by vaccines. Use of Lilly's initial antibodies, bamlanivimab and etesevimab, was first paused because of reduced effectiveness to the beta and gamma variants. They were then reintroduced because they worked against delta, but were limited again, along with Regeneron's antibody cocktail, because they didn't help against omicron.
AbCellera designed bebtelovimab to bind to a portion of the coronavirus that mutates less frequently, with the aim of creating a drug that could treat variants as the virus evolved.
Lilly began testing the drug last year, before the omicron variant became dominant in the U.S. The drugmaker quickly filed for an emergency authorization after early Phase 2 results, even though bebtelovimab hasn’t been tested in patients infected with omicron and hasn’t proven it can keep people out of the hospital.
Lab tests have indicated the drug can neutralize omicron. But the Phase 2 study results so far have only shown that the drug helped patients at low risk of severe disease clear symptoms faster. Treatment with bebtelovimab either alone, or alongside other antibodies, was associated with “generally lower” rates of hospitalization and death than was reported in placebo arms of other similar trials, the FDA said.
Still, those results were enough for the regulator due to the shortage of effective, available tools against omicron. The FDA on Friday cleared bebtelovimab to treat patients with mild to moderate COVID-19 and at risk of progressing to severe disease. Treatment is advised only when other available options, like Pfizer’s antiviral pill Paxlovid, "are not accessible or clinically appropriate," the agency said.
The decision "is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge," said Patrizia Cavazzoni, the director of the FDA’s center for drug evaluation research.
A new drug will help rebuild the government's response to the pandemic. Paxlovid will be a help, but supply is limited to 6 million courses through March 31. The FDA also recently extended its approval for Gilead's antiviral Veklury from hospitalized patients to non-hospitalized patients, but the drug is considered only modestly effective.
Vir's sotrovimab was the lone antibody effective against omicron, and on Thursday the company announced that lab testing suggests it also works against the subvariant BA.2. A separate analysis published as a pre-print Thursday found that it lost effectiveness, however.
Regeneron expects to begin testing this spring on a new antibody that will work against omicron and existing variants of concern, drawn from its library of disease-fighting molecules. That timeline could put them several months behind Lilly in launching a more effective COVID-19 drug. Company executives said in their fourth quarter earnings call that the FDA may offer a more streamlined regulatory pathway for COVID-19 treatments that emerge from the same technology as earlier authorizations.