The emergency authorization, which FDA released Monday, allows the drug to be used in adults and children over the age of 12 with mild to moderate Covid-19 symptoms who are at high risk of progressing to severe disease or requiring hospitalization. Lilly has published limited data from a late-stage trial showing that the antibody reduces the amount of virus in a person’s body, and seems to speed recovery.
The drug has been tested on patients in and out of hospital settings with mixed success. The National Institutes of Health ended a trial last month of Lilly’s antibody treatment in hospitalized coronavirus patients because the drug did not show a benefit. Two ongoing trials are testing an antibody cocktail made by another company, Regeneron, in hospitalized patients, and both companies are testing their drugs in less severely ill patients.
“Authorization of this new Eli Lilly antibody treatment is a significant step forward in treating patients and bridging us to the rollout of safe and effective vaccines, with all of these efforts made possible by #OperationWarpSpeed,” Health and Human Services Secretary Alex Azar tweeted, referring to the government’s drug and vaccine accelerator.