FDA Approves Omvoh for Ulcerative Colitis

FDA Approves Omvoh for Ulcerative Colitis

October 27, 2023
Susan Jara

Adults living with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease that affects millions of individuals worldwide, now have a new treatment option. On October 26, the U.S. Food and Drug Administration (FDA) approved Omvoh (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL) for the treatment of this condition.

Mirikizumab is the first-of-its kind, interleukin-23p19 (IL-23p19) antagonist that targets the p19 subunit of IL-23, a cytokine that plays a crucial role in the inflammation associated with UC. It is a biologic drug designed to offer patients relief from three key symptoms — stool frequency, rectal bleeding, and bowel urgency.

The approval was granted following an assessment of data from the LUCENT program, comprising two randomized, double-blind, placebo-controlled Phase 3 clinical trials. This program encompassed a 12-week induction study (UC-1) and a 40-week maintenance study (UC-2), resulting in a total of 52 weeks of uninterrupted treatment. It’s worth noting that all patients included in the LUCENT program had previously undergone treatments, including biologic therapies, which were either ineffective, lost efficacy, or were intolerable to them.

Key findings from the trials included:

  • Sustained clinical remission: After 12 weeks of using mirikizumab, almost two-thirds (65 percent) of patients had a positive response, and nearly one-fourth (24 percent) achieved clinical remission.
  • Reduced reliance on steroids: Among those who responded well to mirikizumab at 12 weeks, about half (50 percent) achieved steroid-free clinical remission at one year. This means they no longer needed steroids to manage their symptoms.
  • Rapid symptom improvement: Patients saw improvements in symptoms like rectal bleeding and stool frequency as early as three weeks into their treatment.

The drug also showed hope for helping with one of most disruptive aspects of UC, bowel urgency. Patient were given an Urgency Numeric Rating Scale (NRS) to rate their bowel urgency from 0 to 10, with 0 meaning no urgency and 10 the worst possible urgency. At the beginning of the trials, patients had an average score of 7 on this scale. But for those who started with a score of 3 or higher and responded to Omvoh, a significant number (39 percent) reached a weekly average score of 0 to one within a year. Less than two percent of patients experience upper respiratory infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.

“Omvoh addresses key symptoms that matter most to patients and represents our patient-centric approach to treatment innovation,” said Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, in a company press release. “Omvoh’s approval is a significant moment for Lilly’s growing Immunology portfolio, and we are excited to work with the gastroenterology community to set high expectations of care for people living with ulcerative colitis.”

What This Means for Ulcerative Colitis Patients

For people living with ulcerative colitis, having more treatment options means a better chance to ease symptoms and enhance their quality of life. It’s about having more choices to find what works best for you.

To make the most of these options, it’s important to have honest talks with your health care team. Together, you can explore different treatments and create a plan that fits your needs and health history.

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Omvah ((mirikizumab-mrkz) U.S. Prescribing Information. October 2023. https://pi.lilly.com/us/omvoh-uspi.pdf?s=pi.

U.S. Food and Drug Administration. Novel Drug Approvals for 2023.  https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214958Orig1s000ltr.pdf. 



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