Words by Isabel O’Brien
Eli Lilly’s experimental drug mirikizumab has moved a step closer to approval in the European Union for the treatment of Crohn’s disease, following a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The biologic targeting the IL-23p19 pathway has shown significant results in clinical trials, offering new hope for patients with moderately to severely active Crohn’s disease—particularly those who have not responded to existing therapies.
The treatment’s potential was highlighted in the Phase 3 VIVID-1 trial, which showed statistically significant improvements in both clinical remission and endoscopic response. Notably, the trial also reported reductions in the troublesome symptom of bowel urgency, a common issue for Crohn’s patients.
Stefan Schreiber, Director of the Clinic for Internal Medicine. the University Hospital Schleswig-Holstein, Kiel, Germany, commented: “I am excited for the potential of [mirikizumab] as a novel treatment option for patients suffering from moderately to severely active Crohn’s disease, since the majority of patients do not achieve remission on current therapies or cannot maintain it long term.”
The drug’s approval could mark a breakthrough for a disease that affects hundreds of thousands in Europe. Crohn’s disease is a chronic inflammatory condition of the digestive tract, often leading to severe symptoms and, if uncontrolled, long-term complications. Despite the availability of various biologic treatments, many patients still fail to achieve remission, making it imperative to develop additional solutions.
In addition to its clinical benefits, mirikizumab safety profile is consistent with its use in ulcerative colitis, where it was approved in 2023. Adverse effects were generally mild, with upper respiratory infections and joint pain being the most common.
The CHMP’s recommendation now heads to the European Commission for final approval, which is expected in the coming months. Lilly is also awaiting decisions on mirikizumab use in Crohn’s disease in the US and Japan, with approval decisions expected in 2025.
