AbbVie Submits Regulatory Application to EMA for SKYRIZI® (risankizumab) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease

AbbVie today announced that it has submitted an application to the European Medicines Agency (EMA) seeking approval for SKYRIZI ® (risankizumab) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD). The application to the EMA is supported by the recently shared positive data from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, in those with and without prior advanced therapy failure.

"As treatment goals in Crohn's disease continue to evolve, it is important to provide therapies that can deliver meaningful outcomes from the earliest stages of treatment through long-term disease management," said Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. "This submission builds on the growing body of evidence supporting SKYRIZI and reflects our efforts to advancing treatment approaches that may help patients achieve important clinical and endoscopic outcomes." In 2022, SKYRIZI became the first specific IL-23 inhibitor approved for the treatment of Crohn's disease in the European Union (EU) to treat adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. If approved, patients with moderately to severely active CD would have the option to receive their SKYRIZI induction doses via SC injection or through IV infusion and then continue subcutaneous maintenance doses every eight weeks.

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain. It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery. Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically but also emotionally and economically.

AFFIRM is a global, Phase 3, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of SC dosing of risankizumab as an induction treatment in adult patients with moderately to severely active Crohn's disease. Co-primary endpoints were achievement of CDAI Clinical Remission (CDAI < 150) and achievement of endoscopic response at week 12. A total of 289 patients were randomized in a 2:1 ratio to risankizumab SC or placebo. Key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups; 65% of patients had previously failed advanced therapies for the treatment of CD. The study consists of three treatment periods: a placebo-controlled Period A (baseline to week 12) to evaluate the efficacy and safety of risankizumab SC induction treatment, an extended Period B (week 12 to 24) where patients received blinded or open-label treatments based on their clinical response at week 12, and a 52-week open-label extension Period C, where all patients receive the approved risankizumab maintenance treatment. More information on this trial can be found at www.clinicaltrials.gov (NCT06063967).

SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.