Eli Lilly and Company has announced that the U.S. FDA has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. This approval marks a significant milestone for the company, as Omvoh is now approved in the U.S. for two types of inflammatory bowel disease (IBD), following its earlier approval in October 2023 as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults.
Omvoh targets interleukin-23p19 (IL-23p19), a protein that plays a central role in intestinal inflammation. By specifically targeting this protein, Omvoh helps to reduce inflammation within the gastrointestinal tract, which is a key contributor to the symptoms of both Crohn’s disease and ulcerative colitis. The approval of Omvoh in Crohn’s disease is especially significant, as it is the first biologic treatment in more than 15 years to present two-year Phase 3 efficacy data at the time of approval, further underscoring its potential as an effective treatment option for patients.
The Burden of Crohn’s Disease and the Importance of Omvoh Approval
Crohn’s disease is a chronic and often debilitating condition that significantly impacts patients’ quality of life. The disease causes inflammation in the digestive tract, leading to symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The approval of Omvoh provides a new option for adult patients who have struggled to manage their disease with other therapies. Michael Osso, president and CEO of the Crohn’s & Colitis Foundation, commented on the significance of this approval, stating, “The burden of Crohn’s disease on patients’ daily lives is substantial. This approval is meaningful for adult patients with Crohn’s disease, who now have more treatment options available.”
VIVID-1 Study: Positive Phase 3 Results for Omvoh
The FDA’s approval of Omvoh was based on positive results from the Phase 3 VIVID-1 study, which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active Crohn’s disease. These patients had either not responded to or had become intolerant of existing therapies, such as corticosteroids, immunomodulators, or biologics like TNF blockers and integrin receptor antagonists. The VIVID-1 study was a randomized, placebo-controlled trial, with patients randomized to receive either Omvoh or a placebo. Notably, 40% of placebo patients did not achieve a clinical response by patient-reported outcome at 12 weeks and were subsequently switched to Omvoh treatment.
The results from the VIVID-1 trial were impressive, with both primary endpoints achieved:
- Clinical Remission: At the one-year mark, 53% of patients treated with Omvoh achieved clinical remission according to the Crohn’s Disease Activity Index (CDAI), compared to just 36% of patients on placebo (p<0.001).
- Endoscopic Response: Omvoh also showed strong results in terms of endoscopic response, with 46% of patients treated with Omvoh demonstrating visible healing of the intestinal lining at one year, compared to just 23% in the placebo group (p<0.001).
Furthermore, 32% of patients on Omvoh achieved early improvement in endoscopic response, with visible healing at three months, compared to only 11% in the placebo group (p<0.001).
Ongoing Studies and Long-Term Efficacy
Omvoh is also being studied in VIVID-2, an ongoing open-label extension study evaluating the efficacy and safety of Omvoh for up to three years in patients with moderately to severely active Crohn’s disease. The data from VIVID-1 and VIVID-2 suggest that Omvoh may provide long-term benefits. Among patients who achieved endoscopic response at one year in VIVID-1, over 80% maintained this response after an additional year of treatment. Additionally, nearly 90% of patients who achieved both clinical remission and endoscopic response at one year maintained these improvements after two years of continuous treatment.
Safety Profile of Omvoh
The safety profile of Omvoh in patients with Crohn’s disease was generally consistent with its known safety profile in patients with ulcerative colitis. The most common adverse reactions reported in the VIVID-1 study were upper respiratory tract infections, injection site reactions, headache, arthralgia (joint pain), and elevated liver tests. These adverse reactions were observed in at least 5% of patients and occurred more frequently than in the placebo group. The labeling for Omvoh includes warnings and precautions for hypersensitivity reactions, the risk of infection (including tuberculosis), hepatotoxicity (liver damage), and the need for immunizations.
Expert Insights on Omvoh’s Impact
Dr. Marla Dubinsky, a leading expert in pediatric gastroenterology and nutrition at the Icahn School of Medicine at Mount Sinai, New York, commented on the impact of Omvoh for Crohn’s disease patients: “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. 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.”
Global Expansion and Lilly’s Commitment to Patients
Lilly is working on expanding the availability of Omvoh to patients worldwide. The company has submitted marketing applications for Omvoh in Crohn’s disease in the European Union and Japan, with additional global regulatory submissions planned. Currently, Omvoh is approved in 44 countries for the treatment of ulcerative colitis, and its approval for Crohn’s disease will provide more patients with access to this promising treatment.
Dr. Daniel M. Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories and Lilly Immunology, emphasized the company’s commitment to improving patient outcomes: “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. 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.”
Access to Omvoh and Patient Support
Lilly is dedicated to ensuring that patients have access to Omvoh and is collaborating with insurers, health systems, and healthcare providers to facilitate access. Starting January 1, Omvoh has gained first-line biologic coverage from two of the three largest pharmacy benefit managers, which means it is available on formulary in the preferred specialty tier alongside other biologic agents and does not require prior use of other biologics before being prescribed.
Through Lilly Support Services™, the company offers a comprehensive patient support program that includes co-pay assistance for eligible commercially insured patients, helping to reduce the financial burden on patients seeking treatment.
