On October 28, 2025, Eli Lilly and Company announced U.S. FDA approval for OMVOH™ (mirikizumab-mrkz) as the first and only single 500 mg subcutaneous (SC) injection every 4 weeks for maintenance treatment in adults with moderately to severely active ulcerative colitis (UC) who achieved clinical response to OMVOH induction therapy. This update builds on the drug’s October 2023 approval for both induction (300 mg IV at Weeks 0, 4, 8) and maintenance (200 mg SC every 4 weeks), offering a more convenient, higher-dose option to sustain remission longer-term.
Approval stems from the pivotal Phase 3 LUCENT program (LUCENT-1: NCT03518086, n=562; LUCENT-2: NCT03524092, n=676), double-blind, placebo-controlled trials in patients with UC for ≥3 months, inadequate response/intolerance to conventional/prior advanced therapies, and Mayo score ≥6 (endoscopy ≥2). After IV induction, responders were randomized to SC OMVOH 200 mg Q4W, 500 mg Q4W, or placebo Q4W through Week 52.
Primary endpoint: clinical remission (Mayo score ≤2, all subscores ≤1) at Week 52.
- LUCENT-1: 49% (200 mg), 51% (500 mg) vs 25% placebo (both p<0.001).
- LUCENT-2: 48% (200 mg), 52% (500 mg) vs 29% placebo (p<0.001). Key secondaries:
- Endoscopic improvement: 42-45% vs 20-24% (p<0.001).
- HEMI (histologic-endoscopic mucosal improvement): 29-34% vs 13-15% (p<0.001). Sustained benefits through Week 104 in open-label extensions; 49% on 500 mg achieved remission.
Safety: Consistent across doses/durations (>3 years data). Common AEs (≥3% >placebo): upper respiratory infections (14%), arthralgia (8%), injection site reactions (6%), rash (5%). Serious infections: 2.5%; infections: 40% vs 37% placebo. No increased TB/reactivation, malignancy, or deaths vs placebo. Monitor for hypersensitivity.
“This approval transforms UC maintenance by enabling one quick injection every 4 weeks,” said Lotus Yip, Lilly VP, Immunology. Over 50,000 UC patients now have access; Lilly advances Phase 3 in pediatric UC and Crohn’s disease (VIVID/CROHN’S-1 met endpoints). OMVOH, a humanized IgG4 IL-23p19 monoclonal antibody, targets inflammation at the source. Prescribing info updated; available immediately.
