European Commission approves AbbVie’s SKYRIZI for Ulcerative Colitis Treatment

UK— The European Commission has granted authorization for AbbVie’s SKYRIZI® (risankizumab) for the treatment of adult patients with moderately to highly active ulcerative colitis (UC).

This approval targets those who have experienced an inadequate response, lost response, or are intolerant to conventional or biologic therapy. 

According to AbbVie, this marketing authorization for SKYRIZI is its fourth authorized indication in the European Union as the company works to extend treatment choices for UC patients in Europe.

This approval was based on the positive results of two Phase 3 clinical trials, INSPIRE and COMMAND, as emphasized by Roopal Thakkar, M.D., executive vice president of research and development and chief scientific officer at AbbVie.

Dr. Thakkar highlighted that the trials observed positive results in mucosal healing, particularly among patients without prior biologic experience or JAK inhibitor failure.

He noted that the approval of SKYRIZI provides physicians with a new treatment option proven to help a broad range of patients with varying degrees of prior therapy use, whether conventional or biological.

Dr. Thakkar further explained that the European approval of SKYRIZI for UC patients enhances their diversified IBD portfolio, giving healthcare professionals more options to treat their IBD patients effectively.

He also pointed out that this development aligns with AbbVie’s commitment to addressing unmet needs in the IBD community.

Additionally, Edouard Louis, M.D., Ph.D., an INSPIRE trial investigator, commented on the significance of this approval.

He noted that ulcerative colitis is a chronic, unpredictable, and sometimes debilitating disease, and individuals living with this condition require sustained symptom relief.

Prof. Louis explained that patients treated with SKYRIZI in the INSPIRE and COMMAND trials experienced significant improvements in clinical remission and mucosal healing.

These findings are particularly important as mucosal healing goes beyond mere symptom management to restoring the intestinal lining, which is associated with improved long-term outcomes.

The introduction of SKYRIZI as a new treatment option is expected to help UC patients achieve their long-term treatment goals.

This development is especially critical given that UC affects an estimated 5 million people worldwide, with the incidence of the disease on the rise globally.

Common signs and symptoms of UC include diarrhea, abdominal pain, blood in the stool, urgency to defecate, passing mucus from the rectum, and rectal pain and bleeding.

These symptoms often lead to significant discomfort and impair patients’ ability or desire to engage in everyday activities.

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and commercialization efforts globally.

This partnership has brought innovative treatments to patients suffering from inflammatory bowel diseases, ultimately improving their quality of life and long-term health outcomes.