AbbVie Submit EMA Application for Risankizumab in Crohn’s Disease

A route-of-administration line extension for an already-approved biologic is now in front of the European Medicines Agency: AbbVie has filed for subcutaneous induction dosing of risankizumab (SKYRIZI) in adults with moderately to severely active Crohn's disease, adding a new manufacturing and device dimension to a product currently approved only for intravenous induction in the EU.

The submission is backed by the Phase 3 AFFIRM study (NCT06063967), a randomised, placebo-controlled, double-blind trial in 289 patients randomised 2:1 to risankizumab SC or placebo. Co-primary endpoints were CDAI Clinical Remission (CDAI <150) and endoscopic response at week 12. Notably, 65% of enrolled patients had previously failed advanced therapies, broadening the clinical relevance of the dataset across refractory populations.

For fill-finish and device manufacturing teams, the filing signals an expanding scope of work. SC delivery requires a distinct primary container closure system, injection device validation, and extractables and leachables profiling separate from the existing IV formulation. Quality units will need to confirm that any new presentation meets 21 CFR Part 211 and EMA GMP Annex 1 requirements for sterile drug-device combination products, with corresponding process validation packages aligned to ICH Q10 lifecycle principles.

Regulatory affairs leads tracking EMA timelines should note that risankizumab first gained EU approval for Crohn's disease in 2022 as the first specific IL-23 inhibitor in that indication. If the SC induction application clears the Committee for Medicinal Products for Human Use, patients would be able to choose between SC injection or IV infusion for induction, then continue SC maintenance dosing every eight weeks. That optionality introduces labelling complexity and post-approval change management obligations that QA and regulatory teams will need to plan for ahead of any opinion.

The AFFIRM study design includes a 52-week open-label extension period, meaning longer-term safety and efficacy data will continue to accumulate and could inform future label updates or post-marketing commitments under EMA's pharmacovigilance framework.

The measurable checkpoint for operations and regulatory teams is the EMA's formal validation of the submission and the subsequent CHMP review clock, which will set the timeline for any required manufacturing site readiness and device approval activities.

Source: AbbVie News Center via PR Newswire, 27 August 2026.