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# Complete Response on Lilly’s Ulcerative Colitis Drug
- URL: https://www.fdaweb.com/complete-response-on-lillys-ulcerative-colitis-drug/
- Published: 2023-04-14T12:00:00.000Z
- Updated: 2026-09-14T18:25:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154215

FDA has issued Eli Lilly a complete response letter on its BLA for mirikizumab and its use for treating ulcerative colitis (UC). In the letter, the agency cited issues related to the proposed manufacturing of mirikizumab, “with no concerns about the clinical data package, safety, or label for the medicine,” the company says. Lilly recently received approval for mirikizumab as a first-in-class treatment for adults with moderately to severely active UC in Japan. Additionally, the European Medicines Agency s issued a positive opinion for mirikizumab’s use in that region.