Eli Lilly halts COVID-19 treatment citing safety concerns
Health experts have noted that large clinical trials are usually paused when side effects occur.
Drugmaker Eli Lilly said Tuesday that it is pausing its clinical trial of an antibody treatment for COVID-19 due a safety concern.
“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 (DSMB) has recommended a pause in enrollment,” Eli Lilly spokeswoman Molly McCully in a statement, The Hill reports.
Health experts have noted that large clinical trials are usually paused when side effects occur. British drugmaker AstraZeneca recently pumped the brakes on its vaccine trial after a patient fell ill.
An AstraZeneca spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
Eli Lilly’s drug is known as a monoclonal antibody – which is a synthetic version of the antibodies produced by a patient who recovered from the potentially fatal coronavirus, per U.S. News and World Report.
President Donald Trump praised a similar drug made by Regeneron, which he was given following his alleged COVID-19 diagnosis.
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the drug and pharmaceutical company said in a statement of the study, which is named ENSEMBLE “Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”
Eli Lilly has not announced how long the pause might last.
“The trial, evaluating Lilly’s investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study,” the company said in the statement.
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