Enrollment for Eli Lilly's late-stage trial of its monoclonal antibody treatment is being put on hold over potential safety concerns following a recommendation from U.S. health regulators.
“Safety is of the utmost importance to Lilly," an Eli Lilly spokesperson told FOX Business in a statement Tuesday. "We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment."
The trial is used to test the safety and efficacy of Eli Lilly's antibody treatment for hospitalized patients battling COVID-19, and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
A spokesperson for the National Institute of Allergy and Infectious Diseases did not return FOX Business' request for comment by the time of publication.
Eli Lilly submitted an emergency use authorization request to the Food and Drug Administration for its LY-CoV555 antibody treatment last week. The company said in a news release that it anticipated being able to supply as many as 100,000 doses by the end of October, and up to 1 million by next year.
|LLY||ELI LILLY & CO.||195.46||-0.94||-0.48%|
|JNJ||JOHNSON & JOHNSON||170.51||+0.32||+0.19%|
The announcement comes just a day after Johnson and Johnson said it would be pausing its coronavirus vaccine research study due to an adverse reaction by one of the participants.
Eli Lilly stock fell more than 4 percent following the news.