Core Viewpoint - AbbVie's drug, Risankizumab injection, has been approved by the National Medical Products Administration for the treatment of moderate to severe active ulcerative colitis (UC) in adults who have inadequate response, loss of response, or intolerance to traditional therapies or biological agents, marking the second indication approval after Crohn's disease [1]. Group 1 - Risankizumab is the first IL-23 specific inhibitor approved for ulcerative colitis globally, providing a new treatment option for UC patients [1]. - Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to significant gastrointestinal symptoms and complications, with increasing incidence rates in China, particularly among young adults aged 20-49 [1]. - Approximately one-fifth of UC patients are unable to work or study due to their condition, and long-term disease can lead to psychological issues such as sleep disorders, fatigue, and anxiety [1]. Group 2 - The approval of Risankizumab is significant as it targets the IL-23 pathway, a key mechanism in the pathogenesis of ulcerative colitis, aiming to improve symptoms such as abdominal urgency, pain, and sleep disturbances [2]. - The goal of treatment emphasizes long-term stability of the disease without reliance on steroids, which is crucial for enhancing the quality of life for patients [2].
利生奇珠单抗新适应症获批,用于中重度溃疡性结肠炎