The FDA’s approval of Omvoh (mirikizumab-mrkz) for Crohn’s disease—its second IBD authorization since 2023—establishes it as the first biologic in >15 years with Phase 3 two-year efficacy data at launch. In the pivotal VIVID-1 trial, 53% of Omvoh-treated patients achieved clinical remission at one year versus 36% on placebo*, with early endoscopic response tripling placebo rates (32% vs. 11% at three months).
“We found that 53% of patients achieved clinical remission at one year,” said Mark Genovese, M.D., senior vice president, Lilly Immunology Development. “Among those patients, about 90% maintained remission through the second year… It shows a durable clinical effect.”
The approval follows Omvoh’s 2023 ulcerative colitis clearance. Genovese emphasized Omvoh’s IL-23p19 targeting as central to its durability, noting preclinical and genetic data validating the mechanism.
Mark Genovese, M.D.
Genovese also highlighted the broader scope of mirikizumab research, especially in pediatric populations: “Omvoh is part of Lilly’s broader approach to immunology. We view it as a therapy for moderate-to-severe IBD, both ulcerative colitis and Crohn’s.” Ongoing pediatric studies are also in the works. “These are phase 3 programs in pediatric Crohn’s and ulcerative colitis—that’s an important population since the disease can be devastating at a young age,” Genovese added.
Mechanism and differentiation
Omvoh selectively targets the p19 subunit of IL-23, a cytokine linked to inflammation in Crohn’s disease and ulcerative colitis. By narrowing the focus to IL-23p19 (rather than IL-23p40, which can also affect IL-12), Lilly aims to achieve robust efficacy while potentially minimizing off-target effects.
“We’ve known for close to two decades that IL‑23 is an important factor in inflammatory diseases, especially inflammatory bowel disease.… When we block IL‑23, we see substantial improvements in experimental colitis models,” Genovese said.
Beyond symptom control
In VIVID-1, early endoscopic healing (i.e., visible mucosal improvement at three months) was significantly higher among Omvoh-treated patients (32%) vs. placebo (11%). Improvements in bowel urgency, tracked with the Urgency Numeric Rating Scale (UNRS), were also notable. “We also looked at endoscopic response—meaning visible healing of the intestinal lining—and saw similar durability,” Genovese said.
The overall safety profile appears consistent with other biologic treatments, particularly in terms of infection risk and the need to screen for tuberculosis. Mild-to-moderate elevations in liver enzymes and common side effects such as upper respiratory infections and injection site reactions were documented.
Pediatric trials and combination therapy potential
Lilly is conducting Phase 3 pediatric trials in both Crohn’s disease and ulcerative colitis, aiming to address IBD in younger populations. The company’s broader R&D strategy also includes investigating combination approaches—pairing Omvoh with eltrekibart, an anti–neutrophil-trafficking agent—to potentially boost remission rates beyond current ceilings. “We also believe that additional benefits might require combination approaches. Even with the progress we’ve made, we’d like to push efficacy beyond the current ceiling,” Genovese said. “Our hope is that by combining two targeted therapies, we might raise the overall response rates even higher.”
By 2027, Lilly anticipates additional data from ongoing pediatric trials. Combination therapy results with eltrekibart could further push remission rates higher, and the company is also eyeing global expansions, including in the EU and Japan.
* Note: Approximately 40% of placebo patients in VIVID-1 crossed over to Omvoh at Week 12 due to inadequate response.
Filed Under: Biologics, Gastroenterology
