Eli Lilly’s Omvoh recommended by NICE to treat Crohn’s disease in adults

Eli Lilly’s Omvoh recommended by NICE to treat Crohn’s disease in adults

By, Admin 3 June 2025

Eli Lilly’s Omvoh (mirikizumab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat moderately to severely active Crohn’s disease in adults on the NHS in England and Wales.

Eligible Patient Criteria

The health technology assessment agency has recommended in final draft guidance that the drug be used in patients:

  • Whose disease has not responded well enough or stopped responding to a previous biological treatment,
  • Who have not tolerated a previous biological treatment, or
  • Who have been unsuitable for tumour necrosis factor-alpha inhibitors.

Regulatory Background and Supporting Data

NICE’s decision comes less than two months after the Medicines and Healthcare products Regulatory Agency (MHRA) approved Omvoh for use in the UK and was based on positive data from the late-stage VIVID-1 study.

Clinical Trial Results (VIVID-1 Study)

  • Clinical remission at one year was achieved by 45% of Omvoh-treated patients vs 20% on placebo.
  • Visible healing of the intestinal lining at one year was seen in 38% of Omvoh-treated patients vs 9% on placebo.
  • At three months, 33% of Omvoh patients showed early improvement in endoscopic response, compared to 13% on placebo.

Crohn’s Disease: Prevalence and Impact

Crohn’s disease is one of the two main types of inflammatory bowel disease (IBD), affecting more than 500,000 people in the UK.
The condition causes:

  • Persistent diarrhoea
  • Abdominal pain
  • Potential complications requiring hospitalisation or surgery if left uncontrolled

Omvoh’s Mechanism and Previous Approvals

Lilly’s Omvoh is already recommended by NICE for certain cases of ulcerative colitis, the other main form of IBD.
The drug works by targeting the interleukin-23p19 protein, thereby reducing inflammation in the gastrointestinal tract.

Statement from Eli Lilly Leadership

James Neville, Associate Vice President of Specialty Care, Lilly UK and Ireland, stated:

“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] 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 the….”

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!