U.S. officials have ordered a pause to the late-stage trial of Eli Lilly's (LLY) - Get Eli Lilly and Company (LLY) Report coronavirus treatment candidate due to potential safety concerns, the company said.
“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the Activ-3 independent data safety monitoring board has recommended a pause in enrollment,” the company said in a statement to CNBC.
Eli Lilly was working on a therapy combination that combined with other treatments would reduce viral load, symptoms and hospitalizations from covid-19.
Last week, Eli Lilly said that it had submitted a request for emergency-use authorization to the U.S. Food and Drug Administration. The move came after the Indianapolis health-care giant said that its new data showed that the therapy met primary endpoints.
Eli Lilly shares at last check were down 3.5% to $149.02.
On Monday, peer drugmaker Johnson & Johnson (JNJ) - Get Johnson & Johnson (JNJ) Report said that it was pausing its late-stage coronavirus vaccine trial due to an unexplained illness from one of its participants.
Johnson & Johnson said the pause should be temporary, as it reviews data linked to the trial and determines whether the unnamed participant received a dose of the vaccine candidate or a placebo.
The Johnson & Johnson trial, which is part of the U.S. government's Operation Warp Speed effort to develop an effective vaccine for covid-19 and includes some 60,000 volunteers, was the second study in as many months to pause its dosing, following a similar decision by AstraZeneca (AZN) - Get Astrazeneca PLC Sponsored ADR Report in September.
"Adverse events – illnesses, accidents, etc. - even those that are serious, are an expected part of any clinical study, especially large studies. Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines," the company said in a statement.