Omvoh (mirikizumab) — A Lilly Medicine

Dosing

For adults with moderately to severely active UC1

START WITH INFUSIONS EVERY 4 WEEKS FOR 3 DOSES IN TOTAL

Induction Phase

UC: 300 mg per infusiona
MAINTENANCE WITH SUBCUTANEOUS INJECTIONS EVERY 4 WEEKS STARTING AT WEEK 12

Maintenance Phase

UC: 2 × 100 mg injections
  • Initially intravenous infusion, then subcutaneous maintenance injections every 4 weeks, starting at Week 12.1
  • Patients can administer Omvoh with ease and convenience through prefilled pens for maintenance dosing.1

Omvoh is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject after training in proper technique.1

aFor at least 30 minutes.1

bPreparation of 3 × 300 mg per IV infusion dose for at least 90 minutes.

CD=Crohn's disease; UC=ulcerative colitis.

1. Omvoh EUSPC FEB 2025.

Flexible Start With Omvoh In UC1,2

UC dosing flow on a Week 0 to Week 212 timeline: Induction Therapy (Omvoh 300 mg, 20 mg/mL IV infusion ≥30 minutes every 4 weeks, 3 treatments) → Maintenance Therapy (Omvoh 200 mg SC injection every 4 weeks after last IV infusion, one 200 mg prefilled pen for a full dose) → Continue maintenance treatment. Non-responders to induction continue to Extended Induction (Omvoh 300 mg IV infusion every 4 weeks, 3 treatments). Loss of response during maintenance triggers Reinduction (Omvoh 300 mg IV infusion every 4 weeks); non-responders to reinduction consider a discontinuation.
  1. † Omvoh responders in LUCENT-1=551/868 (63.5%); 544 entered LUCENT-2.1,2
  2. ‡ Patients with loss of therapeutic response during maintenance treatment may receive Omvoh 300 mg IV infusion every 4 weeks for a total of 3 doses (reinduction). If clinical benefit is achieved from this additional IV therapy, patients may resume Omvoh SC dosing every 4 weeks. The efficacy and safety of repeated reinduction therapy have not been evaluated.1

IV, intravenous; SC, subcutaneous; UC, ulcerative colitis.

1. Omvoh EUSPC FEB 2025. 2. D'Haens G, et al. Inflamm Bowel Dis. 2024;30(12):2335–2346.

Omvoh offers in-label flexible dosing to help to meet your patients' needs1,2

Extended Induction and Reinduction Dosing1

Extended Induction and Reinduction Dosing timeline. Induction phase: Omvoh 300 mg IV Q4W (3 doses, 12 weeks total) at WK0, WK4, WK8. Maintenance phase: Omvoh 200 mg SC Q4W from WK12 onward. If reinduction is necessary: Omvoh 300 mg IV Q4W (3 doses, 12 weeks total), then resume Omvoh 200 mg SC Q4W. If response is not achieved, consider discontinuation.
  • Some patients may need extended induction therapy following initial induction to achieve clinical response.1
  • If a patient loses response during maintenance therapy, reinduction therapy can help them regain response.1

IV, intravenous; Q4W, every 4 weeks; SC, subcutaneous.

1. Omvoh EUSPC FEB 2025. 2. D'Haens G, et al. Inflamm Bowel Dis. 2024;30(12):2335–2346.

Omvoh Extended Induction Helps Week 24 Response Rates Among Week 12 Non-responders

Majority of patients treated with Omvoh 300 mg IV achieved clinical response at Week 12 (induction) or Week 24 (extended induction)1

Stick-figure timeline from Week 0 through Week 24: 8 navy figures representing Omvoh 300 mg IV induction responders by Week 12, 2 lime figures representing patients who achieved response with extended induction at Week 24, 2 grey figures representing non-responders. Total clinical response rate at Week 24: 80.3% (N=868).

LUCENT-11

• 63.5% of patients achieved early clinical response with IV induction by Week 12 (N=868)

LUCENT-22

• 54% of patients who did not achieve adequate response at Week 12 went on to achieve clinical response at Week 24 with Omvoh extended induction therapy (N=272)

Clinical Response: ≥2-point and ≥30% decrease in the MMS from baseline; RB=0 or 1, or ≥1-point decrease from baseline.

IV, Intravenous; MMS, modified Mayo Score.

1. D'Haens G, et al. N Engl J Med.2023;388(26):2444–2455 (including supplementary index). 2. D'Haens G, et al. Inflamm Bowel Dis. 2024 Jan 25:izae004. Epub ahead of print.

In Total, 80% Of Omvoh-treated Patients Achieved Clinical Responsea At Week 24, Including Week 12 Non-responders Receiving Three Additional Doses1

Clinical response: NRI and mBOCF data1

Induction Response: 63% Clinical Response at Week 12 (induction population N=551/868). After Extended Induction (N=272), Total Response: 80% Clinical Response at Week 24 (N=697/868). With Omvoh's flexible dosing in label, 8/10 patients can achieve a clinical response at Week 24.

a Clinical remission was based on the MMS and was defined as: SF subscore=0 or 1 with a ≥1-point decrease from baseline, RB subscore=0, and ES=0 or 1 (excluding friability).1

Clinical response: ≥2-point and ≥30% decrease in the MMS from baseline: RB=0 or 1, or ≥1-point decrease from baseline.2

IV, intravenous; mBOCF, modified baseline observation carried forward; MMS, modified Mayo Score; NRI, non-responder imputation; RB, rectal bleeding; SC, subcutaneous.

1. D'Haens G, et al. Inflamm Bowel Dis. 2024;30(12):2335–2346. 2. D'Haens G, et al. N Engl J Med.2023;388(26):2444–2455 (+ Suppl. index).