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The National Institute for Health and Care Excellence (NICE) has recommended interleukin-23 (IL-23) inhibitor mirikizumab (Omvoh; Eli Lilly) for the treatment of moderately to severely active Crohn’s disease.
Final draft guidance published on 30 May 2025 said that mirikizumab can be offered on the NHS to people in England with Crohn’s disease where the condition has not responded well enough or stopped responding to previous biological treatments, where a prior biological treatment was not tolerated, or where TNF-alpha inhibitors are not suitable.
The IL-23 inhibitor is already licensed for the treatment of inflammatory bowel disease (IBD) and is currently used at a lower dose to treat ulcerative colitis (UC).
When used to treat Crohn’s disease, mirikizumab will be delivered at a higher dose than when used to treat UC, according to the guidance.
Mohammed Allah-Ditta, advanced gastroenterology pharmacist in IBD medicines management at Calderdale and Huddersfield NHS Foundation Trust, said: “The loading dose is higher at 900mg, longer infusion period of 90 minutes, with frequency remaining as every four weeks for three doses.
“[The] maintenance dose is again higher for the Crohn’s disease induction at 300mg every four weeks post loading doses. As with UC, this is delivered using two injectable devices per administration (200mg and 100mg strength for Crohn’s disease, in any order).”
Allah-Ditta also highlighted that mirikizumab joins risankizumab as the only other IL-23 inhibitor currently licensed for Crohn’s disease.
“Both drugs require IV infusion loading doses but differ in the delivery device and frequency for maintenance doses,” he told The Pharmaceutical Journal.
“Positioning in pathways relative to risankizumab and other second-line options will largely be driven by clinical and patient factors, and NHS discounted drug acquisition costs.”
Marianne Radcliffe, chief executive of Crohn’s and Colitis UK, UK charity dedicated to Crohn’s disease, UC, and other forms of IBD, said: “Crohn’s disease is a lifelong condition affecting more than 200,000 people in the UK, for which there is no cure.
“People tell us how painful and debilitating their symptoms can be and many will have waited a long time for a diagnosis. Existing treatments may stop working over time for some people or may not even work at all.
“People with Crohn’s [disease] don’t want to be stuck in a hospital — they want to be out enjoying their lives. Expanding the treatment options for eligible people living with Crohn’s [disease], with drugs like mirikizumab, can only be a good thing. We welcome this latest development.”
The draft guidance coincides with emerging early stage treatment breakthroughs in autoimmune gut diseases, including a recent coeliac disease study published on 9 June 2025.
Full guidance on mirikizumab is expected to be published on 10 July 2025.
