The Food and Drug Administration has granted an emergency use authorization for a new monoclonal antibody treatment developed by Eli Lilly to fight the Omicron variant of COVID-19. The decision was finalized one day after the pharmaceutical announced it had agreed to supply 600,000 doses of the treatment, called bebtelovimab, to the U.S. government.
The Biden administration said those doses would be distributed across the country for free.
The treatment is authorized for anybody over the age of 12 who is at high risk of experiencing severe complications from COVID-19. The FDA said that bebtelovimab should only be given to patients “for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.”
“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, 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.”
Bebtelovimab expands on the available treatments that work against the Omicron variant. Another antibody treatment made by GlaxoSmithKline has been authorized for patients with the Omicron variant. In addition, a pill created by Pfizer was also granted an emergency use authorization to treat people in the early stages of infection.
A similar antibody treatment made by Eli Lilly, along with one manufactured by Regeneron, had their authorization revoked after they were found to be ineffective against the Omicron variant.