[5][6] In the United States, mirikizumab is indicated for the treatment of adults with moderately to severely active ulcerative colitis.
[4][7][8] In January 2025, the US Food and Drug Administration (FDA) expanded the indication for mirikizumab to include the treatment of moderately to severely active Crohn's disease in adults.
[11] The approval was based on the LUCENT 1 clinical study which evaluated the safety and efficacy of mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
[13][12][14] After twelve weeks of induction treatment, 24% of participants on mirikizumab achieved clinical remission, which compared with 15% for those on a placebo.
[18] The applicant for this medicinal product is Eli Lilly Nederland B.V.[18] Mirikizumab was approved for medical use in the European Union in May 2023.