FDA issues complete response letter for lebrikizumab for eczema treatment

Key takeaways:

• The FDA issued a complete response letter to Eli Lilly and Company for the biologics license application for lebrikizumab.
• The letter did not list clinical data package, safety or label concerns.

The FDA has issued a complete response letter for Eli Lilly and Company’s lebrikizumab biologics license application for moderate to severe atopic dermatitis treatment, according to a manufacturer-issued press release.

The FDA letter cited findings from an inspection of a third-party contract manufacturer that handles lebrikizumab’s monoclonal antibody drug substance, according to the release. It did not, however, include concerns about the clinical data package, safety or label for lebrikizumab, a novel high-affinity monoclonal antibody that binds with interleukin-13.

“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,” Patrik Jonsson, Lilly executive vice president, Lilly president of immunology and Lilly USA and chief customer officer, said in the release. “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.”

Lebrikizumab was submitted for the treatment of adults and adolescents aged 12 years and older with moderate to severe atopic dermatitis that is uncontrolled by topical medicines or other systemic treatments.

The biologics license application submission of lebrikizumab to the FDA was supported by data from the phase 3 program consisting of ADvocate1, ADvocate2 and extension trial ADhere.