NICE recommends mirikizumab (Omvoh ▼) for previously treated moderately to severely active Crohn’s disease 1
pharmafile | May 30, 2025 | News story | Research and Development | Crohn’s disease, Eli Lilly and Company, Gastrointestinal tract, Medicines and Healthcare products Regulatory Agency (MHRA)(, NHS England and Wales, National Institute for Health and Care Excellence (NICE), Omvoh, inflammatory bowel disease (IBD), mirikizumab
In the Phase 3 VIVID-1 trial, patients treated with mirikizumab experienced significant improvement in clinical remission and endoscopic response at one year 2
Among those who achieved endoscopic response at one year, 88% of patients maintained endoscopic response at two years of continuous mirikizumab treatment in open-label extension 3
BASINGSTOKE, May 30, 2025 – Today, Eli Lilly and Company (Lilly) announced that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending mirikizumab (Omvoh) for use on the NHS in England and Wales as an option to treat moderately to severely active Crohn’s disease in adults only if:
- The disease has not responded well enough or stopped responding to a previous biological treatment, or
- A previous biological treatment was not tolerated, or
- Tumour necrosis factor (TNF)-alpha inhibitors are not suitable 1
The final guidance is expected to be published after a period for stakeholders to appeal and to highlight factual inaccuracies.
The announcement comes less than two months after the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for mirikizumab in the United Kingdom. 4 Mirikizumab will be available to eligible patients in England within 30 days of publication of the final guidance, and within 60 days in Wales.
James Lindsay, Professor of Inflammatory Bowel Disease at Barts and the London School of Medicine and Dentistry, Queen Mary University of London and a Consultant Gastroenterologist at Barts Health NHS Trust, comments: “Many patients with Crohn’s disease have explored several of the currently available therapies but are still seeking a treatment option that effectively helps manage their symptoms and reduces the long-term inflammatory burden of the condition. The recent authorisation of mirikizumab is positive news for those living with Crohn’s disease as well as the gastroenterologists and specialists who care for them as it gives a new option for treatment.”
Marianne Radcliffe, CEO of Crohn’s & Colitis UK, said: “Crohn’s disease is a lifelong condition affecting more than 200,000 people in the UK. They tell us all the time how painful and debilitating their symptoms can be, and many will have waited a long time for a diagnosis. There is no cure and existing treatments may not work for some, or may stop working over time. People with Crohn’s don’t want to be stuck in hospital, they want to be out living their lives. Expanding the treatment options for eligible people living with Crohn’s – with drugs like mirikizumab – can only be a good thing!’
“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 James Neville, Associate Vice President of Specialty Care, Lilly UK and Ireland. “With mirikizumab now authorised in both Crohn’s disease and ulcerative colitis, more patients will have access to 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 improving outcomes for patients.”
This authorisation and recommendation is based on positive results from the Phase 3 VIVID- 1 study 2 of mirikizumab 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). VIVID-1 was a randomised placebo-controlled trial of mirikizumab. 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 mirikizumab treatment. Both co-primary endpoints in VIVID-1 were achieved:
- Clinical response by PRO at week 12 and clinical remission by Crohn’s Disease Activity Index (COAi) at week 52
- 45% of patients treated with mirikizumab achieved clinical remission at one year versus 20% on placebo* (p<0.001).
- Clinical response by PRO at week 12 and endoscopic response at week 52
- 38% of patients treated with mirikizumab had visible healing of the intestinal lining at one year versus 9% on placebo* (p<0.001).
Additionally, 33% of mirikizumab patients achieved early improvement in endoscopic response, defined by visible healing of the intestinal lining, versus 13% on placebo at three months (p<0.001).2
*Placebo included patients switched to treatment with mirikizumab at 12 weeks. Mirikizumab’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 ulcerative colitis. The most common adverse reactions with mirikizumab treatment (reported in at least 5% of subjects and at a higher frequency than placebo during induction and through Week 52 of VIVID-1) are COVID-19, arthralgia, headache, and upper respiratory tract infection (most frequently nasopharyngitis).2 The safety information for mirikizumab contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatic enzyme elevations and immunisations.4
Adverse reactions from clinical studies (Table 1) are listed by MedORA system organ class. The frequency category for each reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to< 1/1 000); very rare ( < 1/10 000).4
Table 1: Adverse reactions
| MedDRA System organ class | Frequency | Adverse reaction |
| Infections and infestations | Common | Upper respiratory tract infectionsa |
| Uncommon | Herpes zoster | |
| Immune system disorders | Uncommon | Infusion-related hypersensitivity reactions |
| Musculoskeletal and Connective Tissue Disorders | Common | Arthralgia |
| Nervous system disorders | Common | Headache |
| Skin and subcutaneous tissue disorders | Common | Rashb |
| General disorders and administration site conditions | Very common | Injection site reactionsc |
| Uncommon | Infusion site reactionsd | |
| Investigations | Uncommon | Alanine aminotransferase increased |
| Uncommon | Aspartate aminotransferase increased |
a Includes: acute sinusitis, C0VID-19, nasopharyngitis, oropharyngeal discomfort, oropharyngeal pain, pharyngitis, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, and viral upper respiratory tract infection.
b Includes: rash, rash macular, rash maculo-papular, and rash papular and rash pruritic.
c Reported during mirikizumab maintenance therapy where mirikizumab treatment is administered as subcutaneous injection.
d Reported during mirikizumab induction therapy where mirikizumab treatment is administered as intravenous infusion.
About Crohn’s disease
Crohn’s disease is a chronic, inflammatory bowel disease associated with progressive bowel damage, disability and decreased health-related quality of life. If not adequately controlled, it may lead to complications that require hospitalisation and surgical intervention. A substantial proportion of patients do not experience adequate treatment outcomes, have secondary loss of response to maintenance therapy, or do not tolerate existing therapies, including biologic agents. Patients with previous biologic failure may be more difficult to treat.
About mirikizumab
Mirikizumab is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active Crohn’s disease in adults. Mirikizumab 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 Crohn’s disease. In Crohn’s disease the recommended mirikizumab dose regimen has 2 parts.
Induction dose
The induction dose is 900 mg (3 vials of 300 mg each) by intravenous infusion for at least 90 minutes at weeks 0, 4 and 8.
Maintenance dose
The maintenance dose is 300 mg (i.e. one prefilled syringe or prefilled pen of 100 mg and one prefilled syringe or pre-filled pen of 200 mg) by subcutaneous injection every 4 weeks after completion of induction dosing. The injections may be administered in any order. The 200 mg pre-filled syringe and 200 mg pre-filled pen are only for the treatment of Crohn’s disease.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Reporting suspected adverse reactions after
authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: website,
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
About Eli Lilly and Company
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 UK or Eli Lilly and Company UK & Ireland: Overview I LinkedIn P-LLY
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REFERENCES
1 NICE (2025) Mirikizumab for treating moderately to severely active Crohn’s disease. Final Draft Guidance. Available at: www.nice.org.uk/guidance/indevelopment/gid-ta11267 [Accessed May 2025].
2 M. Ferrante. (2024). Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active controlled, treat-through study. The Lancet. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01762-8/abstract [Accessed May 2025].
3 S Vermeire. (2025). D0P005 Long-term efficacy and safety of mirikizumab treatment for Crohn’s Disease: Results from the VIVID-2 open-label. Journal of Crohn’s and Colitis. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i91/7967055 [Accessed May 2025].
4 Mirikizumab (0mvoh) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/search?q=omvoh [Accessed May 2025].
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