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 other marketed or pipeline Lilly products are affected. 
 
Lilly has submitted data to the FDA from ADvocate 1, ADvocate 2 and ADhere studies, which included over 1,000 adults and adolescents (ages 12 and older) with moderate-to-severe eczema who were unable to control their symptoms with topical medicines or other systemic treatments.
 
Lilly added the IL-13-targeting monoclonal antibody as part of its $849 million acquisition of Dermira in 2020.

“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. “We will continue to work closely with the third-party manufacturer and the FDA to address the feedback in order to make lebrikizumab available to patients.”