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Lilly Receives Complete Response Letter for Lebrikizumab

FDA declines to approve eczema therapy after finding issues at a third-party contract manufacturing organization.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Eli Lilly and Co. was issued a complete response letter from the U.S. FDA for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema). The letter cited findings from a multi-sponsor inspection of a third-party, contract manufacturing organization 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. No o...

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