The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active Crohn's disease who have not responded to previous biological treatment or cannot tolerate it. The decision positions Eli Lilly's interleukin-23p19 inhibitor as a new treatment option for patients with limited therapeutic alternatives.
Regulatory Timeline and Availability
The NICE recommendation comes less than two months after the Medicines and Healthcare products Regulatory Agency granted marketing authorisation for mirikizumab in the UK. Eligible patients in England will have access to the treatment within 30 days of publication of the final guidance, while patients in Wales will gain access within 60 days.
Clinical Trial Evidence
The recommendation was based on positive data from the phase 3 VIVID-1 trial, which demonstrated significant clinical benefits for patients with Crohn's disease. In the study, 45% of mirikizumab-treated patients achieved clinical remission at one year, compared to 20% of those receiving placebo.
The trial also showed substantial improvements in intestinal healing, with 38% of patients receiving mirikizumab demonstrating visible healing of the intestinal lining at one year, compared to only 9% on placebo. Additionally, 33% of patients in the mirikizumab cohort achieved early improvement in endoscopic response at three months, compared to 13% in the placebo group.
Patient Population and Unmet Need
NICE has specified that mirikizumab should be used in patients whose disease has not responded well enough or stopped responding to a previous biological treatment, not tolerated a previous biological treatment, or been unsuitable for tumour necrosis factor-alpha inhibitors.
Crohn's disease is one of the two main types of inflammatory bowel disease (IBD), which affects more than 500,000 people in the UK. The condition specifically impacts more than 200,000 people in the UK and causes symptoms such as persistent diarrhoea and abdominal pain. If not adequately controlled, the disease can lead to complications that require hospitalisation and surgical intervention.
Mechanism of Action and Safety Profile
Mirikizumab is designed to reduce inflammation within the gastrointestinal tract by targeting the interleukin-23p19 protein. The drug's safety profile is generally consistent with its known effects in ulcerative colitis, with common adverse reactions including headache, upper respiratory tract infection and joint pain.
Expert Commentary
James Lindsay, professor of inflammatory bowel disease at Barts and the London School of Medicine and Dentistry, Queen Mary University of London, and consultant gastroenterologist at Barts Health NHS Trust, emphasized the clinical need: "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."
Marianne Radcliffe, CEO of Crohn's & Colitis UK, welcomed the expanded treatment options: "Crohn's disease is a lifelong condition affecting more than 200,000 people in the UK. Expanding the treatment options for eligible people living with Crohn's – with drugs like mirikizumab – can only be a good thing!"
James Neville, associate vice president of specialty care, Lilly UK and Ireland, highlighted the patient impact: "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 them."
Broader Treatment Landscape
Lilly's Omvoh is already recommended by NICE to treat certain cases of ulcerative colitis, another of the two main forms of IBD. The dual indication positions mirikizumab as a versatile treatment option across the inflammatory bowel disease spectrum.
