The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending mirikizumab for use within the NHS in England and Wales for the treatment of adults with moderately to severely active Crohn’s disease, provided certain criteria are met. The recommendation applies to patients whose condition has failed to respond to a previous biologic therapy, where treatment was not tolerated, or where tumour necrosis factor (TNF) inhibitors are deemed unsuitable.

The decision follows the UK marketing authorisation granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025. Under standard implementation timelines, mirikizumab will become available to eligible patients in England within 30 days of the final NICE guidance, and within 60 days in Wales.

The recommendation is based on results from the Phase 3 VIVID-1 trial, which assessed mirikizumab in patients with moderately to severely active Crohn’s disease who had previously shown inadequate response or intolerance to corticosteroids, immunomodulators or biologics. Patients receiving mirikizumab achieved statistically significant improvements across clinical and endoscopic endpoints compared with placebo.

At week 52, 45% of patients treated with mirikizumab achieved clinical remission, compared with 20% on placebo (p<0.001). In terms of endoscopic outcomes, 38% showed visible mucosal healing after one year of treatment, versus 9% on placebo (p<0.001). Early endoscopic response, assessed at three months, was achieved in 33% of mirikizumab-treated patients, compared with 13% on placebo (p<0.001).

Sustained benefit was observed in the open-label extension of the trial, with 88% of those who achieved endoscopic response at one year maintaining it at year two under continued treatment. The safety profile of mirikizumab in Crohn’s disease was generally consistent with that seen in ulcerative colitis, for which the drug is also authorised. Reported adverse events occurring in at least 5% of patients included COVID-19, arthralgia, headache and nasopharyngitis.

Crohn’s disease is a chronic inflammatory condition affecting over 200,000 people in the UK. While there is no cure, disease-modifying therapies aim to manage symptoms, reduce inflammation, and improve long-term outcomes. NICE’s backing of mirikizumab offers an additional option for patients whose disease has proved refractory to other biologic agents.