AbbVie announced the submission of a regulatory application to the European Medicines Agency (EMA) seeking approval for SKYRIZI® (risankizumab) for subcutaneous (SC) induction dosing in adult patients with moderately to severely active Crohn’s disease. If approved, eligible patients will have the flexibility to initiate therapy via SC injection or the already approved intravenous (IV) infusion route, followed by standard SC maintenance dosing every eight weeks.
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. The therapeutic was first approved in the European Union in 2022 as the initial specific IL-23 inhibitor for moderately to severely active Crohn’s disease.
The submission is backed by positive data from the pivotal Phase 3 AFFIRM clinical trial evaluating the efficacy and safety of SC risankizumab induction in 289 adult patients, 65% of whom had previously failed advanced therapies. The study met its co-primary endpoints at Week 12, demonstrating statistically significant superiority over placebo. 55% of patients treated with SC risankizumab achieved CDAI clinical remission (CDAI < 150) compared to 30% on placebo (P<0.0001).44% achieved endoscopic response compared to 14% receiving placebo (P<0.0001).
The overall safety profile aligned with the established profile of risankizumab in Crohn’s disease, with serious adverse events occurring in 0.5% of risankizumab-treated patients compared to 3.1% in the placebo cohort.
“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 at 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.”
Written by: Pragna Biswas
Graphics by: Pramit Hazra
