Currently Enrolling Trials
Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist.
Omvoh is specifically indicated for the treatment of moderate to severe ulcerative colitis in adults.
Omvoh is supplied as an injection for intravenous or subcutaneous use
The labeling for Omvoh contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunizations. For that reason, recommended evaluations and immunizations prior to treatment initiation include:
- Evaluate patients for tuberculosis (TB) infection prior to initiating treatment.
- Obtain liver enzymes and bilirubin levels prior to initiating treatment.
- Complete all age-appropriate vaccinations according to current immunization guidelines.
- The recommended induction dosage of Omvoh is 300 mg administered by intravenous infusion over at least 30 minutes at Week 0, Week 4, and Week 8.
- The recommended maintenance dosage of Omvoh is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter.
Mechanism of Action
Omvoh (mirikizumab-mrkz) is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation. Mirikizumab-mrkz inhibits the release of pro-inflammatory cytokines and chemokines.
Adverse effects associated with the use of Omvoh may include, but are not limited to, the following:
Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.
Clinical Trial Results
The FDA approval of Omvah was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biologic treatments, that did not work, stopped working or that they could not tolerate.