The U.S. FDA has issued a complete response letter for Eli Lilly's BLA for its eczema candidate, following inspection issues at the CMO facility charged with making the drug substance.
According to Lilly, the CRL cited findings that arose during a "multi-sponsor inspection" of a third-party contract manufacturing organization that included the monoclonal antibody drug substance for lebrikizumab.
Lebrikizumab is monoclonal antibody designed to bind IL-13 with very high affinity inhibiting the biological effects of IL-13. Lilly is looking to grab approval for the treatment of moderate-to-severe atopic dermatitis (eczema).
Originally a Roche drug, dermatology specialist Dermira licensed the treatment in 2017. Eli Lilly then picked up the phase 3 drug in its $1.1 billion acquisition of Dermira back in January 2020. Lilly announced that it had submitted the BLA for lebrikizumab, backed by the ADvocate 1, ADvocate 2 and ADhere studies, last November.
Importantly, the FDA's recent letter stated no concerns about the clinical data package, safety or label for lebrikizumab. Lilly says it will work closely with the third-party manufacturer and the agency to address the feedback.