Eli Lilly: FDA Issues CRL For Lebrikizumab BLA Related To Third-party Manufacturing Organization

(RTTNews) - Eli Lilly and Company (LLY) announced the FDA has issued a complete response letter for the lebrikizumab biologic license application for the treatment of moderate-to-severe atopic dermatitis. The company said the FDA 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.

"We are confident in lebrikizumab's potential to help people living with eczema and in the clinical data that supports our submission package for the medicine," said Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer.

The company noted that the FDA stated no concerns about the clinical data package, safety or label for lebrikizumab.

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