US FDA issues complete response letter for lebrikizumab based on inspection findings at third party manufacturer

Eli Lilly

2 October 2023 - In the letter, the FDA stated no concerns about the clinical data package, safety or label for lebrikizumab.

Eli Lilly announced that the US FDA has issued a complete response letter for the lebrikizumab biologic license application for the treatment of moderate to severe atopic dermatitis.

Read Eli Lilly press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier