Lilly's Mirikizumab Case for Crohn's Disease

Eli Lilly's antibody drug, mirikizumab, also marketed under the brand name Omvoh, is showing promising results in the treatment of Crohn’s disease. This follows its previous approval for ulcerative colitis. According to recent data from the phase 3 VIVID-1 trial, mirikizumab has met both co-primary endpoints and all major secondary endpoints after one year of testing, signaling strong efficacy in a patient population that includes those who have previously not responded to biologic treatments.

At the one-year mark, mirikizumab achieved clinical remission in 54.1% of patients and an endoscopic response in 48.4% of patients. These findings were presented at Digestive Disease Week in Washington, D.C. The data indicated that mirikizumab was effective in both bio-naïve patients (those who had never tried biologics) and bio-failed patients (those for whom previous biologics either did not work or lost effectiveness). Specifically, 39.3% of bio-naïve and 36.7% of bio-failed patients on mirikizumab achieved a composite patient-reported clinical response at the 12-week mark and endoscopic response after one year, compared to 11.8% and 6.2% in the placebo group, respectively.

Further analysis showed that, by week 52, 47.3% of bio-naïve and 43.4% of bio-failed patients on mirikizumab reached clinical remission based on the Crohn’s Disease Activity Index (CDAI), compared to 26.5% and 12.4% in the placebo groups. Additionally, in a comparison with Johnson & Johnson’s Stelara (ustekinumab), mirikizumab demonstrated nominally statistically significant higher rates of clinical remission and endoscopic response at week 52, although it did not surpass Stelara in endoscopic response.

Dr. Mark Genovese, Senior Vice President of Lilly Immunology Development, emphasized the significance of these results, noting that more than half of the patients treated with mirikizumab achieved clinical remission after one year, and nearly half achieved an endoscopic response. Remarkably, the majority of those who met one of these endpoints also achieved the other.

In light of this data, Lilly has submitted applications for the use of mirikizumab in treating Crohn’s disease to the FDA and the European Medicines Agency earlier this year and plans to submit to other global regulators. Besides the current VIVID-1 study, Lilly is also investigating the efficacy of mirikizumab in pediatric Crohn’s populations.

Mirikizumab secured its first FDA approval in October, becoming the first IL-23 inhibitor to be approved for ulcerative colitis, a field already populated by biologics from companies such as AbbVie, Johnson & Johnson, and Takeda. This approval came after an initial rejection in April due to manufacturing issues identified during a preapproval inspection. Throughout 2023, mirikizumab also received approvals for ulcerative colitis in Europe and Japan, and a reimbursement recommendation in England.

With these developments, Eli Lilly is building a solid case for mirikizumab's broader application in immunology, aiming to provide new therapeutic options for patients struggling with inflammatory bowel diseases.