Dive Brief:
- Eli Lilly will supply the U.S. government with 600,000 doses of its new COVID-19 treatment should the antibody drug gain emergency authorization from the Food and Drug Administration. 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.
Dive Insight:
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's application for an emergency authorization is now under FDA review, and the contract with the federal government would assure swift rollout should the agency give its OK. Lilly intends for bebtelovimab to treat mild to moderate cases of COVID-19 in patients at risk of progressing to severe disease.
A new drug will help rebuild the government's response to the pandemic. Pfizer's antiviral pill 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.