The US Food and Drug Administration has approved mirikizumab-mrkz (Omvoh) for the treatment of moderately to severely active ulcerative colitis in adults. This approval, announced on October 26, 2023, is based on data from a pair of phase 3 trials within the LUCENT program, making mirikizumab the first and only IL-23p19 antagonist to receive such an indication.
Bruce Sands, MD MS, highlighted the significance of this approval, noting that it offers a novel treatment option for patients who have not found relief with other biologic treatments. The approval is particularly notable for addressing key symptoms such as stool frequency, rectal bleeding, and bowel urgency.
The LUCENT program included two trials, UC-1 and UC-2, focusing on induction and maintenance studies, respectively. Results from UC-1 showed that 24% of patients achieved clinical remission, 65% achieved a clinical response, and 34% achieved endoscopic improvement with mirikizumab, compared to placebo. In UC-2, 51% of patients achieved clinical remission, with 99% of those in remission being steroid-free for at least the previous 12 weeks.
Adverse reactions to mirikizumab included upper respiratory infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection. However, the treatment was noted for its lower likelihood of discontinuation due to adverse events.
The approval of mirikizumab represents a significant advancement in the treatment of ulcerative colitis, offering new hope for patients who have struggled with the condition despite previous treatments. Eli Lilly and Company plans to make mirikizumab available in the US in the coming weeks, marking a pivotal moment in the company's Immunology portfolio and the broader gastroenterology community.
