In the pivotal Phase 3 VIVID-1 trial, patients treated with Omvoh experienced significant improvement in clinical remission and endoscopic response at one year

Among those who achieved clinical remission and endoscopic response at one year, nearly 90% of patients maintained clinical remission with two years of continuous Omvoh treatment in open-label extension

INDIANAPOLIS, IN, USA I January 15, 2025 I Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. Omvoh is now approved in the U.S. for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults.1

Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation. Omvoh is the first biologic treatment in more than 15 years to have disclosed two-year Phase 3 efficacy data in Crohn’s disease at the time of approval.2

“The burden of Crohn’s disease on patients’ daily lives is substantial,” said Michael Osso, president and chief executive officer, Crohn’s & Colitis Foundation. “This approval is meaningful for adult patients with Crohn’s disease, who now have more treatment options available.”

This approval is based on positive results from the Phase 3 VIVID-1 study of Omvoh in adults with moderately to severely active Crohn’s disease who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine and methotrexate) and/or biologics (TNF blockers, integrin receptor antagonists).1 VIVID-1 was a randomized placebo-controlled trial of Omvoh. Patients randomized to placebo who did not achieve clinical response by patient-reported outcome at 12 weeks (40% of placebo patients) were subsequently switched to Omvoh treatment. Both primary endpoints in VIVID-1 were achieved:

  • Clinical remission by Crohn’s Disease Activity Index (CDAI) at one year
    • 53% of patients treated with Omvoh achieved clinical remission at one year versus 36% on placebo* (p<0.001).
  • Endoscopic response at one year
    • 46% of patients treated with Omvoh had visible healing of the intestinal lining at one year versus 23% on placebo* (p<0.001).

Additionally, 32% of Omvoh patients achieved early improvement in endoscopic response, defined by visible healing of the intestinal lining, versus 11% on placebo at three months (p<0.001).

*Placebo included patients switched to treatment with Omvoh at 12 weeks.

Omvoh is also being studied in VIVID-2, an ongoing, open-label extension (OLE) study evaluating the efficacy and safety of Omvoh for up to three years in adults with moderately to severely active Crohn’s disease. Among patients who achieved endoscopic response at one year in VIVID-1, over 80% maintained endoscopic response with one year of additional treatment (two years of continuous treatment). Additionally, among patients who achieved clinical remission and endoscopic response at one year in VIVID-1, nearly 90% of patients maintained clinical remission with one year of additional treatment (two years of continuous treatment).3

In both VIVID-1 and VIVID-2, Omvoh’s overall safety profile in patients with moderately to severely active Crohn’s disease was generally consistent with its known safety profile in patients with UC. The most common adverse reactions (reported in at least 5% of subjects and at a higher frequency than placebo during induction and through Week 52 of VIVID-1) associated with Omvoh treatment were upper respiratory tract infections, injection site reactions, headache, arthralgia and elevated liver tests. The labeling for Omvoh contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunizations. See the Safety Summary below and full Prescribing Information.1

“Many patients with Crohn’s disease have tried available therapies and are still seeking a treatment option that can work well for them to help control their disease,” said Marla Dubinsky, M.D., chief, division of pediatric gastroenterology and nutrition, co-director, Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children’s Hospital, Icahn School of Medicine, Mount Sinai New York. “The FDA approval of Omvoh may help adults with Crohn’s disease achieve long-term remission and visible healing of the intestinal lining, even if they have tried other medications that did not work or stopped working.”

Lilly has also submitted marketing applications for Omvoh in Crohn’s disease around the globe, including in the European Union and Japan. Additional global regulatory submissions are planned. In UC, Omvoh is currently approved in 44 countries.

“People living with Crohn’s disease have shared with us how truly disruptive symptoms such as abdominal pain, frequent bowel movements and bowel urgency can be,” said Daniel M. Skovronsky, M.D., Ph.D., chief scientific officer, and president of Lilly Research Laboratories and Lilly Immunology. “With Omvoh approved in both Crohn’s disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them, reflecting Lilly’s ongoing commitment to elevate care and improve outcomes for patients.”

Lilly is committed to serving patients living with Crohn’s disease and is working with insurers, health systems and providers to enable access to Omvoh. Effective Jan. 1, Omvoh has successfully gained first-line biologic coverage** from two of the three largest pharmacy benefit managers. Through Lilly Support Services™, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.

**First-line biologic coverage means Omvoh is available on formulary in the preferred specialty tier, alongside other products, and does not require failure of other biologic agents prior to use.

View the Omvoh brand logo.

About the VIVID Clinical Trial Program
VIVID-1 is a randomized, double-blind, placebo-controlled 52-week study. Patients received mirikizumab 900mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8 followed by a maintenance dose of 300mg by subcutaneous injection (SC) at Week 12 and then every 4 weeks (Q4W) for 40 weeks. Patients randomized to placebo who did not achieve clinical response by patient-reported outcome at 12 weeks (40% of placebo patients) were subsequently switched to Omvoh treatment. Clinical remission was defined as CDAI <150. Endoscopic response was defined as >50% reduction from baseline in Simple Endoscopic Score for Crohn’s disease (SES-CD) total score, based on central reading. Bowel urgency was also assessed with an Urgency Numeric Rating Scale (UNRS) of 0 to 10.

Participants who completed Week 52 of VIVID-1 and, in the investigator’s opinion, would derive clinical benefit from treatment with mirikizumab, were enrolled in VIVID-2. In VIVID-2, the primary objective is to evaluate the long-term effect of mirikizumab in clinical remission by CDAI and endoscopic response at Week 52 of treatment in VIVID-2 (totaling 104 weeks of continuous treatment). Safety is being assessed from the first dose in VIVID-2. Open-label extension studies may have selection bias as patients who cannot tolerate treatment or do not respond may drop out of the study prior to the extension.

About Omvoh®
Omvoh® (mirikizumab-mkrz) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.

Omvoh® and its delivery device base are trademarks owned by Eli Lilly and Company.

INDICATION AND SAFETY SUMMARY
Omvoh® (ahm-VOH) is a medicine used to treat

  • adults with moderately to severely active ulcerative colitis
  • adults with moderately to severely active Crohn’s disease

It is not known if Omvoh is safe and effective in children under 18 years of age.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY

1 Omvoh. Prescribing Information. Lilly USA, LLC.

2 Data on File. Lilly USA, LLC. DOF-MR-US-0083.

3 Data on File. Lilly USA, LLC. DOF-MR-US-0066.

PP-MR-US-0899 01/2025 © Lilly USA, LLC 2025. All rights reserved.

SOURCE: Eli Lilly