AbbVie (NYSE:ABBV) has submitted an application to the EMA seeking approval for risankizumab (Skyrizi, 600 mg intravenous induction and 360 mg subcutaneous maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
The submission is supported by three Phase 3 studies, ADVANCE, MOTIVATE and FORTIFY.
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea and abdominal pain.
Patients with Crohn's disease live with challenging symptoms, such as persistent diarrhea and abdominal pain, impacting their quality of life.