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Omvoh
Published
Product name
Omvoh
Active ingredient
Mirikizumab
Submission type
New Biological Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Omvoh is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a biological medicine, or have medical contraindications to such therapies.
How this medicine works
Mirikizumab is a humanised immunoglobulin G4 (IgG4) monoclonal antibody that binds with high affinity and specificity to the p19 subunit of human interleukin (IL)-23 cytokine and inhibits its interaction with the IL-23 receptor. It has no observed cross-reactivity to other members of the IL-12 cytokine family (that is, IL-12, IL-27, and IL-35).
Interleukin-23 is an important driver of mucosal inflammation in ulcerative colitis 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 genetic deletion or pharmacological inhibition of IL-23 p19 can ameliorate or prevent intestinal inflammation.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Omvoh was considered favourable for the therapeutic use approved.
Sponsor