Product Dossier
OMVOH
Product Dossier for OMVOH (mirikizumab, Eli Lilly). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Eli Lilly
- Active ingredient: mirikizumab
- Therapeutic area: Gastroenterology
- Same area: SALOFALK
- Same area: COLOFAC
What it is
OMVOH is mirikizumab, available as a solution for injection in multiple formulations including autoinjectors (pre-filled pens), pre-filled syringes, and a concentrated vial for intravenous infusion.
Approved indications
— Treatment of moderately to severely active ulcerative colitis 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.
Regulatory history
OMVOH mirikizumab was first registered on the ARTG on 27 September 2023, with registrations for 100 mg/mL solution for injection autoinjectors, pre-filled syringes, and 300 mg/15 mL concentrated injection vials for intravenous infusion. The TGA approved OMVOH on 26 September 2023 for the treatment of moderately to severely active ulcerative colitis 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. The TGA Delegate considered that the clinical data supported the efficacy and safety of mirikizumab, and that the overall benefit-risk balance was favourable for the proposed indication. The PBAC recommended OMVOH in July 2023 for moderate to severe ulcerative colitis and extended this recommendation for a further 12 months. In July 2025, the PBAC extended the recommendation for a further 12 months. Citrate-free formulations of OMVOH were subsequently registered on 4 July 2025, including autoinjectors, pre-filled syringes, and composite packs.