The Food and Drug Administration (FDA) announced Friday that it has issued emergency use authorization (EUA) for Eli Lilly's new monoclonal antibody treatment.
Clinical trials have shown the treatment to be effective against the COVID-19 omicron variant.
“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.”
According to the Center's for Disease Control, omicron is the dominant variant in the U.S.
The EUA covers treatment for patients with mild to moderate COVID-19 who are at high risk of hospitalization or death.
It can be used on children as young as 12 if they weigh at least 88 pounds, the FDA says.
Prior to the authorization, the U.S. agreed to purchase 600,000 doses. They are to be delivered no later than March 31, Eli Lilly said.