Mirikizumab is now recommended by NICE for routine NHS use in England and Wales in adults with moderately to severely active Crohn’s disease, following prior treatment failure or intolerance to biologics. The move follows a UK marketing authorisation granted just three months ago and could expand options for a significant population of patients with limited alternatives.

Eli Lilly announced that the National Institute for Health and Care Excellence (NICE) has published final guidance recommending mirikizumab for use in adults with moderately to severely active Crohn’s disease, but only under specific conditions. It is approved for NHS use in England and Wales if:

• The disease has not responded adequately to a previous biological therapy

• The previous therapy was not tolerated

• TNF-alpha inhibitors are not suitable

Mirikizumab is expected to be available to eligible patients in England within 30 days of the guidance and in Wales within 60 days.

The NICE recommendation follows a marketing authorisation granted by the MHRA earlier this year and is based on positive data from the Phase 3 VIVID-1 trial. In the study, mirikizumab demonstrated statistically significant improvements in clinical remission and endoscopic healing at one year compared to placebo.

According to trial data:

• 45% of patients receiving mirikizumab achieved clinical remission at 52 weeks versus 20% on placebo

• 38% achieved endoscopic response (visible healing) versus 9% on placebo

• Early endoscopic response at three months was seen in 33% of treated patients versus 13% of placebo recipients

James Lindsay, professor of inflammatory bowel disease at Barts and the London School of Medicine, said the recommendation provides “a new option for treatment” for patients who may have exhausted other therapies.

Marianne Radcliffe, CEO of Crohn’s & Colitis UK, added: “There is no cure and existing treatments may not work for some, or may stop working over time. Expanding the treatment options for eligible people living with Crohn’s – with drugs like mirikizumab – can only be a good thing.”

The drug’s safety profile in Crohn’s disease appears consistent with its use in ulcerative colitis, with the most common adverse events being upper respiratory infections, headache, arthralgia, and COVID-19. The drug is administered intravenously during induction and subcutaneously during maintenance.

Mirikizumab is already approved for ulcerative colitis and now joins the limited list of biologic options recommended for Crohn’s patients who have not responded to earlier lines of therapy — a population for whom unmet need remains high.