EC Approves AbbVie's Skyrizi for Adult Ulcerative Colitis

AbbVie’s Skyrizi (risankizumab-rzaa) has been granted approval by the European Commission (EC) for treating adults with moderately to severely active ulcerative colitis (UC). This approval is aimed at patients who have not responded adequately, lost response, or are intolerant to conventional or biologic therapies.

Ulcerative colitis is a form of inflammatory bowel disease (IBD) affecting an estimated five million people worldwide. It leads to inflammation in the digestive tract and can cause significant damage to the colon lining. Patients often experience unpredictable symptoms, including abdominal pain, bloody stools, and faecal urgency. In severe cases, the disease can result in serious complications, such as cancer.

Skyrizi is an interleukin-23 inhibitor that aims to block a cytokine associated with multiple chronic immune-mediated diseases. Previously, it received approval in the EU for treating Crohn’s disease, plaque psoriasis, and psoriatic arthritis. The treatment regimen for UC includes an initial induction period involving three 1200mg intravenous doses every four weeks. This is followed by maintenance doses of either 180mg or 360mg administered every eight weeks via subcutaneous injection.

The recent approval by the EC took into account positive results from two late-stage clinical trials. The INSPIRE study was designed to evaluate the safety and efficacy of a 1200mg intravenous dose of Skyrizi given every four weeks as an induction therapy in patients with moderately to severely active UC. Additionally, the 52-week COMMAND study assessed the effects of 180mg or 360mg subcutaneous doses as a maintenance therapy in adults with the same condition.

Both trials successfully met their primary endpoint of clinical remission and achieved crucial secondary endpoints, including endoscopic improvement and histologic endoscopic mucosal healing. These results are significant because mucosal healing extends beyond symptom management, contributing to the restoration of the intestinal lining and improved long-term outcomes.

Edouard Louis, a trial investigator from Liège University, highlighted the importance of these findings, noting that mucosal healing is associated with better long-term health outcomes. Roopal Thakkar, AbbVie’s executive vice president for research and development and chief scientific officer, emphasized that the new approval offers physicians an additional treatment option that has been proven to help a wide range of patients with varying histories of prior therapy use.