AbbVie's IL-23 Inhibitor Risankizumab Granted Clinical Trial Approval in China for Moderate to Severe Crohn’s Disease

Source: Medical Panorama

The latest public announcement from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration indicates that AbbVie’s IL-23 inhibitor, risankizumab injection (ABBV-066), has received implicit approval for two clinical trials, intended for the treatment of moderate-to-severe Crohn’s disease. Notably, AbbVie recently announced that risankizumab met the primary endpoints in the induction phase of two Phase 3 clinical trials evaluating its efficacy in adult patients with moderate-to-severe Crohn’s disease.

Screenshot source: CDE official website

Risankizumab is an interleukin-23 (IL-23) inhibitor that specifically blocks IL-23 by binding to its p19 subunit. IL-23 is a cytokine involved in inflammatory processes and is believed to be associated with many chronic immune-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 psoriasis who are candidates for systemic therapy or phototherapy.

According to the public information released by the Center for Drug Evaluation (CDE), risankizumab had previously been approved for multiple clinical trials in China, targeting indications such as active psoriatic arthritis in adults, moderate-to-severe Crohn’s disease, and moderate-to-severe ulcerative colitis. The two clinical trials granted implicit approval this time are indicated for the treatment of moderate-to-severe Crohn’s disease in adolescents aged 16 years and older and adults.

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In clinical trials, risankizumab has demonstrated potential for the treatment of moderate-to-severe Crohn’s disease. In January 2020, AbbVie announced that risankizumab met the primary endpoints in the induction phase of two Phase 3 clinical trials named ADVANCE and MOTIVATE. In these two clinical trials, patients with moderate-to-severe Crohn’s disease received treatment with varying doses of risankizumab.

In the ADVANCE clinical study, based on the Crohn’s Disease Activity Index (CDAI) assessment, the proportion of patients achieving clinical remission at Week 12 was significantly higher among those treated with risankizumab (600 mg or 1200 mg) (45% and 42%, respectively) compared to 25% in patients receiving placebo. Similar results were observed for clinical remission assessed by the Patient-Reported Outcome index PRO-2. At Week 12, the proportion of patients achieving endoscopic remission was also significantly increased following treatment with either dose of risankizumab. Furthermore, similar efficacy outcomes were demonstrated in the separate MOTIVATE study.

Crohn’s disease is a chronic systemic condition characterized by inflammation within the gastrointestinal tract, leading to persistent diarrhea, abdominal pain, and rectal bleeding, with symptoms that worsen over time. Due to the unpredictable nature of its symptoms, Crohn’s disease imposes significant physical, emotional, and financial burdens on individuals living with the condition.

We wish the subsequent clinical studies of risankizumab every success, bringing new treatment options to patients at an early date.

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