Eli Lilly & Co. (LLY) Friday said that the U.S. Food and Drug Administration has issued an emergency-use authorization for bebtelovimab, the company’s antibody treatment for COVID-19.
Bebtelovimab can now be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.
Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19.
“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.”
The EUA was based on analyses from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14.
As previously announced, Lilly has signed an agreement with the U.S. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million.
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