Drug updated on 1/31/2025
Dosage Form | Injection (intravenous: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial; subcutaneous: 100 mg/mL solution in a single-dose prefilled pen or syringe, 200 mg/2 mL solution in a single-dose prefilled pen or syringe) |
Drug Class | interleukin-23 antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- OMVOH is indicated for the treatment of moderately to severely active ulcerative colitis in adults
- OMVOH is indicated for the treatment of moderately to severely active Crohn’s disease in adults
Latest News

Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- In ulcerative colitis (UC) among the biologic/Janus Kinase Inhibitor (JAKi)-naive population, induction studies showed that upadacitinib demonstrated significant improvements in clinical response and remission compared to most other interventions. In maintenance studies, mirikizumab showed significant improvements compared to most interventions. Among the biologic/JAKi-experienced population, mirikizumab significantly improved clinical response and remission compared to adalimumab, while upadacitinib showed significant improvement compared to all other interventions. Endoscopic mucosal healing rates were similar across active treatments in both induction and maintenance periods.
- In Crohn’s disease (CD), upadacitinib, vedolizumab, adalimumab, guselkumab, mirikizumab, ustekinumab, and risankizumab demonstrated statistically significant efficacy across clinical, endoscopic, histological, genetic, biomarker, and quality-of-life parameters, while PF-00547659 only showed statistically significant results for the Crohn’s Disease Activity Index 70 (CDAI-70) at week 12.
- In UC, similar rates of serious adverse events were reported across all active interventions during the induction period, regardless of prior treatment exposure.
- In CD, all included biologic drugs were well tolerated, with most adverse effects being mild and low in incidence.
- In UC, the biologic/JAKi-naive and biologic/JAKi-experienced populations were identified, with mirikizumab and upadacitinib showing significant improvements in these subgroups. In CD, adult patients with moderate-to-severe disease who had an inadequate response or intolerance to conventional therapy also constituted a distinct subgroup benefiting from biologic treatments.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Omvoh (mirikizumab-mrkz) Prescribing Information. | 2025 | Eli Lilly and Company, Indianapolis, IN |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and Safety of Advanced Therapies in Moderately-to-Severely Active Ulcerative Colitis: a Systematic Review and Network Meta-analysis | 2024 | Advances in Therapy |
The Efficacy and Safety of Biologic Drugs in the Treatment of Moderate-Severe Crohn's Disease: A Systematic Review | 2023 | Pharmaceuticals (Basel, Switzerland) |