FDA CRL - Eli Lilly And Company

The FDA issued a Complete Response Letter (CRL) to Eli Lilly and Company for its Biologics License Application (BLA 761279) for LY3074828 injection, indicated for moderately to severely active ulcerative colitis. The application cannot be approved in its current state due to several deficiencies. Key issues include unresolved deficiencies identified during a pre-license inspection of Lilly’s Indianapolis manufacturing facility. Additionally, the submitted Prescribing Information, Medication Guide, Instructions for Use, and carton/container labeling require significant revisions to comply with regulatory content and format standards (e.g., 21 CFR 201.56, 201.57, 208.24(d)). The FDA also requires a comprehensive safety update, including new nonclinical and clinical data, detailed adverse event summaries, updated exposure, worldwide safety experience, and translations of foreign labeling, as stipulated by 21 CFR 314.50(d)(5)(vi)(b). Furthermore, the application lacks data for at least one drug product lot suitable for commercial release, a requirement for biologics licensing per 21 CFR 601.20(b)(1), and clarification on its availability and manufacturing timeline is needed. To proceed, Eli Lilly must resolve all facility deficiencies, submit fully compliant and revised labeling, provide the requested safety update, clarify product lot details, and resubmit the proposed proprietary name. A complete resubmission addressing all issues is required within one year.