FDA Approves Single-Injection Maintenance Regimen of Mirikizumab-mrkz for Ulcerative Colitis

The FDA has approved mirikizumab-mrkz (Omvoh; Eli Lilly and Company), a 200-mg/2-mL once-monthly maintenance single injection for subcutaneous treatment in adults with moderate to severe active ulcerative colitis (UC), offering patients a simplified therapy by replacing the previous 2-injection regimen. This approval joins past indications granted for mirikizumab, following earlier approvals for Crohn disease and the citrate-free formulation.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. "A single monthly injection of Omvoh gives patients a regimen that's easier to manage alongside the unpredictability of living with ulcerative colitis."¹

Understanding Mirikizumab

Mirikizumab is an IL-23p19 antagonist that targets the p19 subunit of IL-23, thereby inhibiting the IL-23 pathway. Overactivation of the IL-23 pathway contributes significantly to inflammation and plays a key role in the development of inflammatory bowel disease (IBD).¹

Treatment with mirikizumab begins with 3 intravenous infusions every 4 weeks, each lasting for about 30 minutes for UC and 90 minutes for Crohn disease. After induction, maintenance doses are given as self-administered subcutaneous injections every 4 weeks using prefilled pens or syringes.¹

Currently, mirikizumab is available as a 300-mg/15-mL single-dose vial and during maintenance as a 200-mg/2-mL prefilled pen or syringe for UC and a 100-mg/mL and a 200-mg/2-mL prefilled pen or syringe for Crohn disease.¹

Signs and Symptoms of Ulcerative Colitis

As a type of IBD, UC causes inflammation and sores, also known as ulcers, in the colon. The condition commonly starts in the rectum before expanding upward through part or all of the colon; however, patients may not experience immediate symptoms, and they vary depending on the severity of inflammation and its location. This could include diarrhea, blood in the stool, belly pain and cramping, rectal pain, urgency to pass stool, not being able to pass stool despite urgency, weight loss, fatigue, and fever.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 the Crohn's and Colitis Center at OU Health, said in the news release. "With this approval, patients who respond to induction therapy with [mirikizumab] can continue maintenance therapy with the convenience of just 1 injection each month—delivering the same proven results with fewer injections."¹

Data Supporting Single-Injection Approval

The approval for the single-injection formulation of mirikizumab is supported by a phase 1 study that demonstrated a 200-mg injection is bioequivalent to the previously approved two 100-mg injections. For UC, treatment begins with 3-mg intravenous infusions every 4 weeks, followed by subcutaneous self-injections every 4 weeks starting at week 12 for maintenance.¹

Mirikizumab was first approved by the FDA based on the LUCENT (NCT03518086) clinical program, marking the drug as the first IL-23p19 antagonist approved for adult patients with moderately to severely active UC. Following the initial approval, mirikizumab has been approved in 45 countries.³

"At Lilly, we are committed to supporting people living with IBD by delivering meaningful clinical outcomes and continuing to improve their treatment experience," Ashley Diaz-Granados, senior vice president of US Immunology at Lilly, said in the news release. "Building on the introduction of a citrate-free formulation of Omvoh earlier this year, this approval further delivers on our commitment by providing patients the same outcomes in a single-injection maintenance regimen that fits more seamlessly into their lives."¹

REFERENCES

1. Lilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis. News release. Eli Lilly and Company. October 27, 2025. Accessed October 28, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-approved-us-fda-single-injection

2. Ulcerative colitis. Mayo Clinic. Updated October 21, 2025. Accessed October 28, 2025. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326

3. FDA approves mirikizumab for moderately to severely active ulcerative colitis. Pharmacy Times. October 27, 2023. Accessed October 28, 2025. https://www.pharmacytimes.com/view/fda-approves-mirikizumab-for-moderately-to-severely-active-ulcerative-colitis