Eli Lilly receives CRL from FDA for lebrikizumab BLA

Eli Lilly announced that the FDA has issued a complete response letter, or CRL, for the lebrikizumab biologic license application, or BLA, for the treatment of moderate-to-severe atopic dermatitis. The letter cited findings that arose during 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 other marketed or pipeline Lilly products are affected.