Latest news on Mirikizumab in 2025

On January 15, 2025, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Mirikizumab (Mirikizumab)-Omvoh for the treatment of adults with moderately to severely active Crohn's disease. This approval marks an important development for Omvoh in the treatment of inflammatory bowel disease (IBD), as it was approved as a first-line treatment for adults with moderately to severely active ulcerative colitis (UC) back in October 2023. Today, Omvoh has received approval for the treatment of two types of inflammatory bowel disease, showing its important application potential in the treatment of intestinal diseases.

Omvoh works by targeting interleukin-23 (IL-23), a protein that plays a key role in intestinal inflammation. By inhibiting the signaling of this protein, Omvoh can effectively reduce the inflammatory response in the gastrointestinal tract, thereby improving patients' clinical symptoms. This makes Omvoh the first biotherapeutic drug in more than 15 years to disclose efficacy data from a Phase III clinical trial for Crohn's disease upon approval, a milestone.

Crohn's disease places a significant burden on patients' daily lives. This approval provides adult patients with more treatment options and has important clinical significance. Omvoh’s approval was based on positive results in the VIVID-1 study, which was conducted specifically to evaluate adult patients with moderately to severely active Crohn’s disease, specifically those who have had an inadequate response to or are intolerant to conventional treatments such as corticosteroids, immunomodulators (such as azathioprine, 6-mercaptopurine, and methotrexate), and biologics (such as TNF blockers and integrin receptor antagonists).

VIVID-1 was a randomized placebo-controlled trial, and the results showed that the proportion of patients treated with Omvoh who achieved clinical remission after 12 weeks was significantly higher than that of the placebo group, reaching 53% (vs. 36% in the placebo group, p<0.001). In addition, the endoscopic response of Omvoh patients within one year was also excellent, with 46% of patients showing significant intestinal healing, compared with only 23% of the placebo group (p<0.001). These data not only demonstrate the advantages of Omvoh in clinical efficacy, but also lay the foundation for its widespread application in the future.

Results from the VIVID-1 study also showed that 32% of Omvoh patients achieved early improvement in endoscopic response within 3 months, a significant difference compared to 11% of the placebo group (p<0.001). These results fully demonstrate that Omvoh can quickly and effectively improve intestinal inflammation in the short term, providing clinicians with new treatment options when dealing with complex cases.

In addition,Omvoh is also ongoing in the VIVID-2 study, an open-label extension (OLE) study designed to evaluate the efficacy and safety of Omvoh for up to three years in adults with moderately to severely active Crohn's disease. In the VIVID-1 study, more than 80% of patients achieved endoscopic response within one year, and this rate remained unchanged after an additional year of treatment. Nearly 90% of patients who achieved clinical remission and endoscopic response in the VIVID-1 study maintained clinical remission through one year of continuous treatment, further demonstrating the long-term effectiveness of Omvoh.

Reference materials:https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease