FDA CRL - Eli Lilly And Company

Eli Lilly and Company received notification from the FDA that its Biologics License Application (BLA) 761306 for lebrikizumab injection could not be approved in its current form. The decision followed a Remote Regulatory Assessment (RRA) and pre-license inspection (PLI) of a drug substance manufacturing facility, where significant deficiencies were identified and remain unresolved. These issues raised concerns about the reliability of data submitted in the BLA, specifically impacting the comparability between commercial and clinical materials, and thus the adequacy of the proposed lebrikizumab drug substance manufacturing process and overall control strategy. Additionally, the FDA requested further process validation data for the pre-filled syringe needle safety device (PFS-NSD) manufacturing process.

To address these, Lilly must resolve all facility deficiencies and provide satisfactory responses to the inspection team. The FDA recommends engaging an independent third party to conduct a comprehensive assessment of the impacted data and information, with the protocol confirmed as adequate by the agency. A comprehensive safety update is required, and the conditionally acceptable proprietary name, Ebglyss, must be resubmitted. All proposed labeling comments are reserved until other issues are resolved. Under the Public Health Service Act and relevant FDA regulations, Eli Lilly must resubmit the application, fully addressing all deficiencies, within one year.