AbbVie Gains EU Approval for SKYRIZI® in Treating Severe Ulcerative Colitis in Adults

AbbVie has announced that SKYRIZI® (risankizumab) has received marketing authorization from the European Commission for treating adult patients with moderately to severely active ulcerative colitis (UC). This is the fourth approved indication for SKYRIZI® in the European Union.

This approval is grounded in data from two pivotal Phase 3 trials: the INSPIRE induction trial and the COMMAND maintenance trial. Both studies showed that SKYRIZI® met the primary endpoint of clinical remission, using the Adapted Mayo Score, and achieved key secondary endpoints, including mucosal healing and histologic endoscopic mucosal healing.

Professor Edouard Louis, an investigator in the INSPIRE trial, highlighted the significance of these findings. He emphasized that patients treated with SKYRIZI® experienced notable improvements in clinical remission and mucosal healing, which is linked to better long-term outcomes. This new treatment option provides hope for patients dealing with the chronic and unpredictable nature of UC.

UC affects about 5 million people globally, with its incidence rising. The disease commonly presents symptoms such as diarrhea, abdominal pain, blood in stools, and rectal pain, significantly impacting patients' quality of life by reducing their ability to engage in daily activities.

Roopal Thakkar, executive vice president at AbbVie, acknowledged the importance of this approval, noting that SKYRIZI® offers a new treatment option for a broad range of UC patients, regardless of their prior therapy experiences. The approval in the EU enhances AbbVie's portfolio for treating inflammatory bowel disease (IBD), providing healthcare professionals with more treatment choices.

SKYRIZI® is administered through an initial induction dose of 1,200 mg via intravenous infusion at weeks 0, 4, and 8. From week 12 onwards, maintenance doses of either 180 mg or 360 mg are given every eight weeks, depending on the patient's individual needs.

The INSPIRE trial showed that a significantly higher percentage of patients achieved clinical remission at week 12 with risankizumab compared to placebo. Similarly, the COMMAND trial demonstrated that a higher proportion of patients on risankizumab achieved clinical remission at week 52 compared to those in the induction-only control group.

Mucosal healing was another crucial endpoint. In the INSPIRE trial, 37% of patients treated with risankizumab achieved mucosal healing at week 12 compared to 12% on placebo. In the COMMAND trial, mucosal healing at week 52 was seen in 51% of patients on 180 mg and 48% on 360 mg of risankizumab, compared to 32% in the control group.

Histologic endoscopic mucosal healing was also significantly improved in patients treated with risankizumab compared to those on placebo in both trials.

The safety profile of SKYRIZI® was consistent with previous studies, with no new safety concerns detected. Common adverse events included COVID-19, anemia, nasopharyngitis, and arthralgia. The findings from the INSPIRE and COMMAND trials were published in the Journal of the American Medical Association (JAMA) in July 2024.

SKYRIZI® is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading its global development and commercialization. The drug is an interleukin (IL)-23 inhibitor that selectively blocks the IL-23 cytokine, which plays a role in inflammatory processes associated with chronic immune-mediated diseases. SKYRIZI® has received approvals for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

AbbVie remains committed to advancing research in gastroenterology, aiming to alleviate the burden of conditions like UC and Crohn's disease. This approval is a testament to AbbVie's dedication to improving treatment options for patients suffering from these debilitating conditions.