APEli Lilly & Co. said Monday the U.S. Food and Drug Administration has issued a complete response letter for its lebrikizumab, a treatment for moderate-to-severe atopic dermatitis, after an inspection at a third-party manufacturer. The letter, which means the FDA cannot approve the drug for now, was based on findings from an inspection of a plant that included the monoclonal antibody drug substance for Lilly’s lebrikizumab. “The letter stated no concerns about the clinical data package, safety or label for lebrikizumab,” said Lilly, which is confident the data support its submission package for the medicine. The stock LLY fell 0.6% premarket but is up 47% in the year to date, while the S&P 500 SPX has gained 11.7%.
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