FDA rejects Eli Lilly’s eczema drug due to third-party manufacturing issues
FDA has rejected Eli Lilly’s eczema treatment lebrikizumab due to issues found at an unnamed third-party manufacturer.
According to a press release, a “multi-sponsor” inspection found issues at the manufacturer, including ones relating to the monoclonal antibody drug substance for Lilly’s lebrikizumab. The complete response letter did not state any concerns with safety or labeling for lebrikizumab, the company wrote.
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