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FDA ends authorization for the COVID antibody treatment bebtelovimab

Virus Outbreak New Antibody Drug
Darron Cummings
/
AP
In this April 26, 2017, file photo shows the Eli Lilly and Co. corporate headquarters in Indianapolis. Eli Lilly has halted commercial distribution of bebtelovimab after the FDA ended emergency use authorization of the monoclonal antibody treatment for COVID.

The Food and Drug Administration says the Eli Lilly drug is no longer approved for emergency use because it is ineffective against current omicron strains.

The changing nature of COVID-19 variants has taken out the final monoclonal antibody treatment used to fight the virus.

The Food and Drug Administration announced Wednesday that Eli Lilly's bebtelovimab is no longer authorized for emergency use because it is ineffective against current omicron strains BQ.1 and BQ.11.

"Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time," the FDA said in a news release.

Eli Lilly has halted commercial distribution of bebtelovimab, the FDA said. Eli Lilly and other companies are reportedly working on updated antibody therapies.

The number of cases remain lower and flatter since a major surge this past summer due to the highly transmissible omicron subvariants BA.4 and BA.5. However, a winter surge has been predicted by many health experts due to newer strains.

The FDA decision was expected after other monoclonals were also deemed ineffective. Those included bamlanivimab, casirivimab and sotrovimab.

However, preventive booster vaccines have been developed that target subvarients. Also, treatments such as Paxlovid, Veklury and Lagevrio have become preferred approaches against BQ.1 and BQ.1.1 patients that show mild to moderate symptoms.

Antibody treatments were early stars in the battle against the coronavirus. Nearly a year ago, Gov. Ron DeSantis lauded state-run distribution of monoclonals such as Regeneron and bickered with federal authorities over availability. Before vaccines were developed, former President Donald Trump received monoclonal antibodies in 2020, calling the treatment a “miracle.”

Originally founded in December 2006 as an independent grassroots publication dedicated to coverage of health issues in Florida, Health News Florida was acquired by WUSF Public Media in September 2012.