FDA Approves Mirikizumab as Once Monthly Injection for Moderately to Severely Active Ulcerative Colitis

The FDA approved mirikizumab-mrkz (Omvoh) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC). The indication is for a single, once monthly maintenance injection.¹

"In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience," Miguel Regueiro, MD, a board-certified gastroenterologist specializing in inflammatory bowel disease, said in a news release.¹ "A single monthly injection of Omvoh gives patients a regimen that's easier to manage alongside the unpredictability of living with ulcerative colitis."

The approval is based on a phase 1 study comparing the 200 mg/2 mL injection to 2 100 mg/1 mL injections. The single injection showed bioequivalence to the previously approved 2-dose regimen, according to the results. At the beginning of the study, patients received treatment with mirikizumab at a loading dose of 300 mg via intravenous infusion every 4 weeks for 3 infusions before transitioning to subcutaneous maintenance at week 12.¹

Eli Lilly also released data for the drug that showed improvements in moderately to severely active ulcerative colitis, and bowel urgency experienced early improvements in bowel urgency, severity, frequency, and stool deferral time at week 12. Further, the company reported that these outcomes continued to improve through 28 weeks.²

In the phase 3b study, LUCENT-URGE (NCT05767021), investigators aimed to determine how mirikizumab would affect bowel urgency in adults with ulcerative colitis. Patients included had an established diagnosis of ulcerative colitis for 3 or more months, a diagnosis of moderately or severely active ulcerative colitis, current bowel urgency, and demonstrated inadequate response to, or loss of response to, a biologic, Janus kinase inhibitor, or sphingosine-1 phosphate receptor. The primary outcome included change from baseline in bowel urgency severity using the Urgency Numeric Rating Scale. Secondary outcomes included change from baseline in bowel urgency frequency and percentage of individuals achieving clinically meaningful improvements in bowel urgency frequency, stool deferral time intervals, and clinically meaningful improvements in stool deferral time.³

In the study, bowel urgency was reduced by 52% at week 28, with the average rating scale dropping from 6.9 at baseline to 3.7 at week 12. At week 28, the rating dropped to 3.3. For frequency, investigators reported a 55% reduction from baseline in the number of times they experienced bowel urgency, from 6.9 to 3.1, respectively. It was maintained at week 28. For stool deferral time, the proportion of patients who were able to delay a bowel movement for at least 15 minutes or experienced no urgency increased from 4.1% to 15% at week 12 and to 29.7% at week 28.²

"People living with the constant discomfort and disruption caused by the symptoms of ulcerative colitis need treatments that offer the potential to achieve lasting remission and a convenient dosing option that fits easily into their lives," George Salem, MD, director of Crohn's and Colitis Center at University of Oklahoma Health, said in the news release.¹ "With this approval, patients who respond to induction therapy with Omvoh can continue maintenance therapy with the convenience of just one injection each month—delivering the same proven results with fewer injections."

READ MORE: FDA Updates Resource Center

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REFERENCES

1. Lilly’s Omvoh (mirikizumab-mrkz) approved by US FDA as a single-injection maintenance regimen in adults with ulcerative colitis. News release. Eli Lilly. October 27, 2025. Accessed October 28, 2025. https://prnmedia.prnewswire.com/news-releases/lillys-omvoh-mirikizumab-mrkz-approved-by-us-fda-as-a-single-injection-maintenance-regimen-in-adults-with-ulcerative-colitis-302595733.html

2. Lilly’s Omovoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis. News release. Eli Lilly. October 27, 2025. Accessed October 28, 2025. https://lilly.gcs-web.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-demonstrated-early-and-sustained

3. A study of mirikizumab (LY3074828) in participants with moderately to severely active ulcerative colitis (LUCENT-URGE). ClinicalTrials.gov identification: NCT05767021. Updated October 28, 2025. Accessed October 29, 2025. https://clinicaltrials.gov/study/NCT05767021