AbbVie Seeks EMA Approval for SKYRIZI® in Crohn's Disease Treatment with New Application

AbbVie Submits New Regulatory Application for SKYRIZI®

AbbVie, a global biopharmaceutical leader, announced on August 27, 2026, that it has filed a regulatory application with the European Medicines Agency (EMA). The application seeks approval for SKYRIZI® (risankizumab) as a subcutaneous (SC) induction therapy for adults suffering from moderately to severely active Crohn's disease (CD).

This new submission is underpinned by positive findings from the Phase 3 AFFIRM study, a pivotal trial that analyzed the safety and efficacy of risankizumab SC for CD patients. The study assessed patients who had either previously experienced treatment failures with advanced therapies or had yet to try such treatments.

Dr. Roopal Thakkar, AbbVie’s Executive Vice President and Chief Scientific Officer, emphasized the importance of evolving treatment strategies for Crohn's disease: “As treatment goals in Crohn's disease continue to change, it is essential to provide therapies that yield significant benefits from early treatment stages through long-term disease management.”

Background on SKYRIZI and Crohn's Disease

In 2022, SKYRIZI made history by becoming the first specific IL-23 inhibitor to gain approval for treating Crohn's disease within the European Union. This treatment option is particularly vital for patients who have not adequately responded to, lost response to, or were intolerant of conventional therapies or biologics. If AbbVie receives EMA approval, patients will have the flexibility to choose between receiving their SMARTZ® induction dosing via subcutaneous injection or intravenous infusion, followed by maintenance doses every eight weeks.

Crohn's disease is a chronic inflammatory condition that typically affects the gastrointestinal tract, leading to symptoms like persistent diarrhea and abdominal pain. Its progressive nature can cause significant distress not only physically but also emotionally and financially for those impacted.

Details of the AFFIRM Study

The Phase 3 AFFIRM study was a global, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness and safety of risankizumab SC for induction therapy. The trial involved 289 adult patients diagnosed with moderately to severely active Crohn's disease. The co-primary endpoints included achieving a Clinical Remission as defined by the Crohn's Disease Activity Index (CDAI < 150) and endoscopic response at the 12-week mark. Approximately 65% of participants had previously failed to respond to advanced treatment options, underscoring the population's unmet needs.

During the trial, patients were divided into two groups in a 2:1 ratio, with some receiving SC risankizumab and others a placebo. The study included three distinct phases: a placebo-controlled phase evaluating induction treatment over the first 12 weeks, an extended treatment period where patient responses were assessed, and a 52-week open-label extension phase offering all participants the established risankizumab maintenance treatment.

Looking Towards the Future

AbbVie remains committed to advancing treatment options for Crohn's disease patients who require effective management strategies. In addition to the proposed subcutaneous administration of risankizumab, the application represents a significant milestone in the ongoing journey to optimize disease management for Crohn's sufferers.

Recognizing the unrelenting burden that Crohn's disease poses, AbbVie is dedicated to providing accessible and meaningful options for those in need. With over 1 million patients already benefiting from AbbVie's immunology pipeline, the company strives to redefine treatment standards across immune-mediated conditions. For more information about AbbVie and their products, visit AbbVie Immunology.

Important Safety Information

Risankizumab is contraindicated for those with hypersensitivity to the active component or any excipients. Patients with significant infections, including tuberculosis, should exercise caution. Appropriate screening for TB is recommended before initiating treatment. Some common adverse reactions include upper respiratory infections, tinea infections, headaches, and fatigue. For complete safety information, refer to the product's Summary of Product Characteristics (SmPC).

AbbVie’s ongoing commitment to research and innovation furthers the potential for significant advancements in the treatment landscape for Crohn's disease and other immune-mediated conditions globally. Together, these efforts illuminate a pathway to improved patient outcomes and quality of life.