AbbVie IL-23 inhibitor approved in China for clinical treatment of Crohn's disease

AbbVie's IL-23 inhibitor, the Risankizumab Injection (ABBV-066), has received two clinical trials with implied permission to treat moderate to severe Crohn's disease, according to the latest publicity from the Drug Review Center (CDE) of China's National Drug Administration. It's worth noting that AbbVie recently announced that risankizumab has reached the primary endpoint of the induction phase in two Phase 3 clinical trials for adult patients with moderate to severe Crohn's disease.Risankizumab is an IL-23 (leukocyte interleukin 23) inhibitor that specificly blocks IL-23 by binding to the p19 sub-base of IL-23. IL-23 is a cytokine involved in the inflammatory process and is thought to be associated with many chronic immuno-mediated diseases. In the United States, risankizumab was approved by the FDA in April 2019 for the treatment of adult patients with moderate to severe plaque-like psoriasis suitable for systemic or phototherapy.According to CDE public information, risankizumab has previously been approved in China for a number of clinical trials, targeting adaptations including adult active psoriasis arthritis, moderate-severe Crohn's disease, moderate-severe ulcerative colitis and so on. The two clinical trials approved for this approval are implied for the treatment of moderate to severe Crohn's disease in adolescents and adults 16 years of age and older.In clinical trials, risankizumab has shown the potential to treat moderate to severe Crohn's disease. In January 2020, AbbVie announced that risankizumab had reached the primary endpoint of the induction phase in two Phase 3 clinical trials called ADVANCE and MOTIVATE. In both clinical trials, patients with moderate to severe Crohn's disease were treated with different doses of risankizumab.In the ADVANCE clinical study, patients treated with risankizumab (600 mg or 1200 mg) achieved significantly higher rates of clinical remission at the 12th week (45 percent and 42 percent, respectively), while 25 percent of patients treated with a placebo were treated, according to the Crohn's Disease Activity Index. Similar data were obtained for clinical remission assessed on the patient reporting outcome index PRO-2. At the 12th week, the proportion of patients who achieved endoscopic remission was also significantly increased after receiving any dose of risankizumab. In another MOTIVATE study, a similar effect was shown.Crohn's disease is a chronic systemic disease that manifests it as inflammation in the gastrointestinal tract, causing persistent diarrhea, abdominal pain, and rectal bleeding, and worsens over time. Because the symptoms of Crohn's disease are difficult to predict, it can be a significant physical, emotional and financial burden on people living with the disease.I wish the follow-up clinical study of risankizumab a smooth start and bring new treatment options to patients at an early time. (Medical Mission)