CHMP Endorses AbbVie's Risankizumab for Moderate to Severe Ulcerative Colitis in Adults

AbbVie has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending the approval of risankizumab (SKYRIZI®) for treating adults with moderately to severely active ulcerative colitis (UC). The recommendation is based on successful results from two pivotal Phase 3 trials, INSPIRE and COMMAND, which evaluated the drug's efficacy and safety in this patient population.

Ulcerative colitis (UC) is a chronic, immune-mediated inflammatory bowel disease (IBD) primarily affecting the large intestine. The condition is idiopathic, meaning its exact cause is unknown, and it often leads to significant health burdens and disability. Typical symptoms include rectal bleeding, abdominal pain, bloody diarrhea, and fecal urgency. The course of the disease varies, ranging from mild cases to severe, refractory conditions that may require surgical intervention.

In the INSPIRE induction trial, patients received 1200 mg of intravenous (IV) risankizumab at weeks 0, 4, and 8. The primary endpoint was achieving clinical remission by week 12, as measured by the Adapted Mayo Score, which considers stool frequency, rectal bleeding, and endoscopic findings. Secondary endpoints included clinical response, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI). The trial successfully met all these endpoints.

Following the induction phase, the COMMAND maintenance trial continued to assess patients who responded to the IV induction dose. Participants were re-randomized to receive either 180 mg or 360 mg of subcutaneous (SC) risankizumab or to enter a control group where they discontinued the drug. This phase aimed to evaluate the efficacy and safety of SC risankizumab as a maintenance therapy over 52 weeks. The primary goal was to maintain clinical remission, with key secondary objectives including endoscopic improvement, HEMI, and steroid-free clinical remission. The trial also met these key endpoints, providing robust evidence of the drug’s potential for long-term disease management.

The safety profile of risankizumab in both trials was consistent with previous studies across other indications, showing no new safety risks. Common adverse events included upper respiratory infections, tinea infections, headaches, fatigue, and injection site reactions.

Dr. Edouard Louis, a leading investigator in the INSPIRE trial, highlighted the significance of these findings, noting that treatment goals for UC are evolving from mere symptom control to achieving endoscopic remission and mucosal healing. Such outcomes are linked to favorable long-term results, including reduced hospitalizations and improved quality of life.

AbbVie’s Vice President of Immunology Clinical Development, Dr. Kori Wallace, emphasized the company’s dedication to advancing treatment options for patients with UC. AbbVie looks forward to the final decision from the European Commission, expected in the third quarter of 2024, which could mark a significant milestone in the management of this challenging condition.

Risankizumab (SKYRIZI) is an interleukin (IL)-23 inhibitor that blocks the p19 subunit of IL-23, a cytokine involved in inflammatory processes. The drug is already approved for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease. Its use in UC is currently under evaluation in the European Union.

The development and commercialization of risankizumab are part of a collaboration between AbbVie and Boehringer Ingelheim, with AbbVie leading globally. The company is committed to ongoing research and innovation in gastroenterology, aiming to mitigate the burden of IBD and enhance the quality of life for those affected.