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American experiment for Lilly antibody therapy to the end; No safety problem

Eli Lilly & Co.  Products before revenue figures

Photographer: Daniel Acker / Bloomberg

Pause clinical trial of The experimental antibody therapy of Eli Lilly & Co. will not resume once federal researchers have concluded that the drug is unlikely to help hospitalized patients with Covid-1

9 with advanced cases.

However, researchers from the National Institutes of Health, who initially stopped the study due to safety concerns, did not find that the treatment had caused any harm, which could prejudge a regulatory review of antibody use in a different setting.

Although the decision to discontinue the NIH-sponsored study means that Lilly’s treatment with antibodies may not work for the most extreme cases, other studies are underway to determine if it helps patients earlier in the disease. Of note, the finding that there is no safety issue in the hospital trial could remove a potential hurdle to the emergency solution that Lily is seeking to use the antibodies in patients outside the hospital.

On October 13, an independent data safety monitoring board for the so-called ACTIV-3 study, sponsored by the National Institute of Allergy and Infectious Diseases, part of the NIH, recommended that the study be stopped due to safety concerns. Since then, the board has found no difference in safety risks between the groups of patients receiving the antibody known as LY-CoV555 and those who did not.

This means that it is no longer possible for a hospital study to detect an unexpected safety problem that will spread to non-hospitalized patients where the antibody has shown promising results.

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