By Fineline Cube 
AbbVie (NYSE: ABBV) announced that it has submitted an application to the European Medicines Agency (EMA) for the SKYRIZI (risankizumab) subcutaneous (SC) induction regimen for the treatment of adult patients with moderately to severely active Crohn’s disease (CD). If approved, the filing would give European patients the option to receive their induction doses entirely via SC injection — removing the need for intravenous infusion and further cementing SKYRIZI’s position as a leading IL-23 inhibitor in inflammatory bowel disease.
Regulatory Milestone
| Element | Detail |
|---|---|
| Agency | European Medicines Agency (EMA) |
| Submission Type | Application for new induction regimen |
| Product | SKYRIZI (risankizumab) subcutaneous (SC) induction |
| Indication | Adults with moderately to severely active Crohn’s disease (CD) |
| Date | 27 Aug 2026 |
| Current Status | Application submitted; pending EMA review |
Drug Profile & Mechanism of Action
- Molecule: Risankizumab, marketed as SKYRIZI
- Target: Interleukin (IL)-23 — selectively blocked by binding to its p19 subunit
- Mechanism: IL-23 is a cytokine involved in inflammatory processes and is thought to be linked to a number of chronic immune-mediated diseases
- Current EU Position: In 2022, SKYRIZI became the first specific IL-23 inhibitor approved in the European Union for Crohn’s disease, indicated for adult patients with moderately to severely active CD who have had inadequate response, lost response, or were intolerant to conventional or biologic therapy
- Approved Indications: Plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis — approved by both the U.S. Food and Drug Administration and the European Medicines Agency
Patient Treatment Pathway – Current vs. Proposed
| Phase | Current Regimen | If SC Induction Approved |
|---|---|---|
| Induction | IV infusion (or SC option where approved) | Choice of SC injection or IV infusion |
| Maintenance | Subcutaneous doses every eight weeks | Subcutaneous doses every eight weeks (unchanged) |
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. The all-subcutaneous pathway addresses a persistent patient preference for needle-based convenience over infusion-center visits in chronic IBD care.
Market Impact & Outlook
- Franchise Defense: The SC induction filing protects AbbVie’s established SKYRIZI franchise in Crohn’s disease against rivals advancing their own needle-free or subcutaneous induction strategies
- Patient Preference Economics: Offering a choice between SC injection and IV infusion at induction broadens addressable uptake among patients and clinicians seeking to minimize infusion-center dependency
- IL-23 Class Leadership: As the first specific IL-23 inhibitor approved for CD in the EU, SKYRIZI holds the incumbency advantage; streamlined dosing reinforces that first-mover position
- Cross-Indication Synergy: With approvals spanning plaque psoriasis, psoriatic arthritis, CD, and ulcerative colitis from both the FDA and EMA, AbbVie leverages a single molecule across multiple immune-mediated markets
Forward‑Looking Statements – This brief contains forward-looking statements regarding regulatory review, approval timing, and commercial potential. Regulatory submissions may not result in approval. Actual results may differ materially. Not investment advice.-Fineline Info & Tech