FDA gives early-use authorization to Lilly’s new COVID-19 antibody

Eli Lilly and Co. has won emergency use authorization for a new COVID-19 antibody that it says works against omicron and all other known variants of the virus.

The U.S. Food and Drug Administration gave authorization on Friday afternoon for the drug, called bebtelovimab, for use in people 12 and older who have COVID-19 and are at high risk of progression to severe illness, including hospitalization or death.

The antibody, which is administered by infusion, will be free for patients.

The Indianapolis-based drugmaker said Thursday it planned to supply up to 600,000 doses of the antibody to the U.S. government if it won early use authorization. The deal calls for the federal government to pay Lilly more than $720 million.

It’s the third antibody that Lilly has developed for treatment of COVID-19. In December, the U.S. government paused distribution of Lilly’s two previous antibodies, saying they did not appear effective against the omicron variant. Those antibodies, bamlanivimab and etesevimab, were administered together in a cocktail.

Unlike vaccines, the antibodies do not prevent a person from getting infected with the virus, but are designed to neutralize the disease if given after a person is infected.

Lilly executives said during an earnings conference call last week they had already manufactured several hundred thousand doses of the antibody and had submitted the drug to the FDA for emergency use authorization.

The drugmaker said that early testing demonstrated that the antibody is effective against omicron, which is currently the predominant variant in the United States.

The tests also show that the antibody “retains neutralization against all other known variants of interest and concern, including BA.2,” Lilly said, referring to an Omicron subvariant that has been gaining traction in some parts of the world.

The supply agreement calls for the delivery of up to 600,000 doses no later than March 31, with an option of 500,000 additional doses no later than July 31.

Lilly rang up $2.24 billion in sales of bamlanivimab and etesevimab last year, representing about 8% of its total revenue, according to full-year and fourth-quarter results released last week.