AD Pipeline Update: FDA Rejects Lilly’s Lebrikizumab Due to Third-Party Manufacturing Issues

he FDA stated no concerns about the clinical data package, safety or label for lebrikizumab.

The U.S. Food and Drug Administration (FDA) did not approve Eli Lilly's lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis due to findings during an inspection of a contract manufacturer.

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, the Company reports.

"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," says Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, in a news 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."

Lilly has submitted data to the FDA from ADvocate 1, ADvocate 2 and ADhere studies, which included more than 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.