AbbVie announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of risankizumab (SKYRIZI®) for treating adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapy. The recommended induction dose is 1200 mg intravenously (IV), followed by a maintenance dose of 180 mg or 360 mg subcutaneously (SC), depending on the patient’s condition. The final decision by the European Commission is expected in the third quarter of 2024.
Dr. Edouard Louis, professor and head of gastroenterology at Liège University Hospital and dean of faculty at Liège University, commented on the significance of the INSPIRE and COMMAND Phase 3 trials. He noted that patients with moderately to severely active UC can now aim for long-term goals beyond symptom control, such as histologic-endoscopic mucosal healing. This advancement is crucial as treatment objectives are evolving towards achieving endoscopic remission, which is associated with better long-term outcomes, including reduced hospitalizations and improved quality of life.
The CHMP’s positive opinion is supported by data from two Phase 3 trials: the INSPIRE induction trial and the COMMAND maintenance trial. The INSPIRE trial assessed the efficacy of a 1200 mg IV induction dose of risankizumab at weeks 0, 4, and 8 in patients with moderately to severely active UC. Patients who responded to the induction treatment in the INSPIRE trial were then rerandomized in the COMMAND trial to receive 180 mg or 360 mg SC risankizumab as maintenance doses for an additional 52 weeks. The safety profile of risankizumab was consistent with previous trials, with no new safety risks identified.
Dr. Kori Wallace, vice president of immunology clinical development at AbbVie, emphasized the company’s dedication to advancing treatment options for patients through continuous research and development in gastroenterology. AbbVie looks forward to the EMA’s final decision on risankizumab for UC, which has the potential to help patients achieve their long-term treatment goals.
Currently, risankizumab is not approved for UC in the European Union, and its safety and efficacy are still under evaluation.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the global development and commercialization efforts.
About Ulcerative Colitis (UC)
UC is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine, causing continuous mucosal inflammation from the rectum to the colon. Symptoms include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus, urgency, and fecal incontinence. The severity and course of UC can vary, sometimes leading to surgery or life-threatening complications, imposing a substantial burden on patients.
About the INSPIRE Induction Trial
INSPIRE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of 1200 mg IV risankizumab as induction therapy in patients with moderately to severely active UC. The primary endpoint is clinical remission at week 12, with secondary endpoints including clinical response, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI). Top-line results were shared in March 2023.
About the COMMAND Maintenance Trial
COMMAND is a Phase 3, multicenter, randomized, double-blind, controlled trial evaluating the efficacy and safety of 180 mg or 360 mg SC risankizumab as maintenance therapy for 52 weeks in patients who responded to IV risankizumab induction in the INSPIRE trial. The primary endpoint is clinical remission at week 52, with key secondary endpoints including endoscopic improvement, HEMI, and steroid-free clinical remission. Top-line results were shared in June 2023.
About Risankizumab (SKYRIZI)
SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit, a cytokine involved in inflammatory processes linked to several chronic immune-mediated diseases. SKYRIZI is approved by the U.S. FDA and EMA for treating plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
EU Indications and Safety Information for SKYRIZI
SKYRIZI is indicated for moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease in adults. It is contraindicated in patients with hypersensitivity to its components or active infections. It may increase infection risk, and patients should be monitored for signs of infection and tuberculosis. Vaccinations should be updated before starting SKYRIZI, and live vaccines should be avoided during and after treatment. Common adverse reactions include upper respiratory infections, tinea infections, headache, pruritus, fatigue, and injection site reactions.
For full safety information, see the Summary of Product Characteristics (SmPC) at www.ema.europa.eu. Prescribing information may vary by country; consult the local product label for complete information.
