The U.S. Food and Drug Administration (FDA) has rejected Eli Lilly’s (NYSE: LLY) application for lebrikizumab, an anti-IL-13 biologic intended for the treatment of moderate-to-severe atopic dermatitis. The company announced the setback this week, highlighting the challenges faced in the regulatory approval process.
Background on Lebrikizumab’s Acquisition
Eli Lilly acquired lebrikizumab in 2020 as part of its purchase of dermatology specialist Dermira for approximately USD 1.1 billion. This monoclonal antibody (mAb) was seen as a promising late-stage candidate to address significant unmet needs in atopic dermatitis treatment.
Reasons for FDA Rejection
The FDA’s refusal stemmed from “findings” identified during an inspection of a contract manufacturing organization (CMO) responsible for producing lebrikizumab. Importantly, Eli Lilly clarified that there were no issues related to the clinical data supporting the drug. The company plans to collaborate with the CMO to resolve the identified manufacturing concerns.
Recent Regulatory Challenges for Eli Lilly
This rejection marks the second setback for Eli Lilly in 2023, following a negative response from the FDA regarding mirikizumab, a first-in-class anti-IL-23p19 mAb for ulcerative colitis (UC), also due to manufacturing process issues. These challenges underline the complexities of bringing innovative therapies to market.-Fineline Info & Tech
