In the fiercely competitive inflammatory bowel disease (IBD) market, Eli Lilly is making the case for its antibody Omvoh as a holistic solution for patients living with ulcerative colitis or Crohn’s disease—and one that could offer relief after other biologic drugs have failed, too.
The new findings, which tied Omvoh (mirikizumab) to patients meeting multiple simultaneous treatment goals in ulcerative colitis (UC) and Crohn’s at one year of treatment, leveraged fresh analyses of Lilly’s Lucent and Vivid programs in the respective IBD indications, including through the use of a newly devised composite outcome metric in UC, Lilly said Thursday.
First approved for UC back in Oct. 2023, Omvoh ranks among Lilly’s stable of key products expected to drive sales growth in the coming years. The medicine completed its trek into Crohn’s disease last January and, roughly a year ago, the antibody drug also scored FDA clearance in a single-injection, once-monthly maintenance regimen for adults with moderately to severely active UC.
In Lilly’s most recent earnings report, the Indianapolis pharma logged second-quarter sales for Omvoh at $102 million, marking a roughly 36% jump over the $75 million the medicine generated for the period in 2025.
Still, IBD is one of the most hotly contested commercial disease spaces, and Omvoh is facing down a slew of entrenched biologic giants, such as AbbVie’s Skyrizi, Johnson & Johnson’s Stelara and Tremfya, and Takeda’s Entyvio, to name a few.
In presenting the post-hoc data Thursday—also being featured at the annual United European Gastroenterology Week kicking off in Barcelona this weekend—Lilly drew attention to the fact that the multifaceted IBD outcomes it gleaned were also observed in patients with prior biologic failure—a population the company argued often faces greater treatment challenges.
More than a third of patients in the UC analysis and nearly half of those in the Crohn’s post-hoc had previously dealt with biologic treatment failure, Lilly said.
For the analyses of Lilly’s Lucent-2 trial in UC, Lilly devised a composite outcome on “comprehensive disease control” defined by parallel symptomatic, endoscopic and histologic remission, biomarker normalization and no use of corticosteroids.
In the Vivid-1 follow-up in Crohn’s, Lilly used a composite outcome of corticosteroid-free deep remission, marked by simultaneous clinical remission, endoscopic remission and no steroid use.
"Treatment in inflammatory bowel disease is often measured one endpoint at a time,” Anabela Cardoso, SVP of Lilly immunology medical affairs, said in a statement.
“These new data show that patients treated with Omvoh achieved multiple treatment goals simultaneously at one year, including those with prior biologic failure, and were more likely to report better quality of life,” she continued, adding that the results show that for patients with UC and Crohn’s disease, “a higher bar for disease control is achievable.”
Beyond the composite outcomes Lilly assessed for, the company added in its announcement Thursday that patients who met the defined endpoints were also more likely to achieve remission according to the Inflammatory Bowel Disease Questionnaire (IBDQ), a patient-reported measure of health-influenced quality of life.
“Together, these findings reflect an evolution of treatment goals in inflammatory bowel disease (IBD), looking across symptoms, inflammation and impact of disease on daily life to support a more holistic, patient-centered approach that goes beyond clinical remission,” the company argued.
Digging deeper into the results, 27.7% of Omvoh patients in the UC analysis hit Lilly’s comprehensive disease control threshold compared to 14% on placebo. Looking specifically at people who’d experienced prior biologic failure, 23.4% who received Omvoh achieved comprehensive disease control, versus 9.4% in the control cohort.
Meanwhile, more than 91% of patients on Omvoh who achieve comprehensive disease control also struck on IBDQ remission, versus 65.2% of those who got a dummy drug. Omvoh was also linked to fewer reports of minimal bowel urgency and work productivity in those patients, as compared to participants who did not achieve disease control.
In the Crohn’s analysis, meanwhile, 20.4% of patients on Omvoh hit the corticosteroid-free deep remission goal versus 2% of participants on placebo, and among those with prior biologic failure, 15.7% of Omvoh-treated patients hit that goal, compared to none in the control arm.
While Omvoh now has its core indications in IBD locked down, Lilly is continuing to pursue opportunities to move the needle further with the drug in gastroenterology, namely through a number of combination studies that it says are “aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety.”
Several such examples include a phase 2 trial pairing Omvoh with the neutrophil inflammation-targeting antibody eltrekibart in UC, and another midstage study in combination with α4β7 integrin inhibitor zotemtegrast in the same indication.
And in Crohn’s, Lilly is both looking at wedding mirikizumab with an FXR agonist and assessing the concurrent use of Omvoh with an incretin therapy—the category that includes Lilly’s GIP/GLP-1 blockbuster Zepbound—in adults with UC or Crohn’s who are also living with obesity or overweight and at least one other weight-related health condition.