AIFA approves Mirikizumab reimbursement for Crohn's disease in Italy

The Italian Medicines Agency (AIFA) has approved the reimbursement of Mirikizumab for the treatment of moderate to severe active Crohn's disease in adults. This new therapeutic option is intended for patients who have shown an inadequate response, lost response, or are intolerant to conventional therapies or other biological treatments.

Mirikizumab acts as an interleukin-23p19 (IL-23p19) antagonist. The molecule was previously approved by AIFA in 2024 for the treatment of moderate to severe active ulcerative colitis. Crohn's disease is a chronic inflammatory bowel disease that affects the entire gastrointestinal tract; it is estimated to affect approximately 100,000 people in Italy, with diagnoses most common among young adults aged 15 to 40.

In Sicily alone, there are approximately 11,000 patients, many of whom are young adults between 20 and 25 years old. Medical experts note that the drug's mechanism of action blocks a cytokine responsible for the chronic inflammation, offering the potential for significant clinical responses and long-term remission, which may help prevent severe complications requiring hospitalization or surgery.