AbbVie Gains EC Approval for SKYRIZI in Pediatric Plaque Psoriasis with New Weight-Based Pre-Filled Syringe

A new weight-based dosage form now requires fill-finish alignment across AbbVie's EU supply chain: the European Commission has approved risankizumab (SKYRIZI) for children and adolescents aged six and older with moderate to severe plaque psoriasis, adding a 55 mg pre-filled syringe (PFS) to the existing 150 mg adult presentation to support patients weighing less than 40 kg.

The approval rests on data from the Phase 3 OptIMMize-1 (NCT04435600) and OptIMMize-2 (NCT04862286) programs. OptIMMize-1 enrolled two lead-in pharmacokinetic cohorts: a randomized, efficacy assessor-blinded, active-controlled cohort covering ages 12 to under 18, and a single-arm open-label cohort covering ages 6 to under 12. OptIMMize-2 served as the open-label extension. In the combined pediatric population (n=137), the safety profile was consistent with the adult plaque psoriasis dataset, with no new safety signals identified.

For biologics manufacturers and QA leads tracking EMA pediatric regulatory pathways, the introduction of a distinct PFS format carries tangible fill-finish consequences. Weight-based dosing in a sub-40 kg population demands tighter fill-volume accuracy, container-closure integrity validation specific to the new presentation, and labeling controls that distinguish the 55 mg device from the 150 mg adult syringe at the point of dispensing. Process validation documentation under ICH Q10 and applicable 21 CFR Part 211 equivalents in EU GMP Annex 1 will need to reflect the separate manufacturing stream if the two presentations share fill lines.

The clinical context sharpens the regulatory rationale. Nearly one-third of people living with psoriasis develop symptoms before age 18, yet approximately 70% of pediatric patients remain on topical therapies alone, indicating a significant gap in systemic treatment access. The EC approval positions risankizumab as one of the few IL-23 inhibitors with a dedicated pediatric indication and a purpose-built delivery format in the EU market.

Risankizumab selectively blocks IL-23 by binding to its p19 subunit and holds EMA approval across four indications in adults: plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The pediatric psoriasis approval extends the label but does not alter the adult presentations currently in distribution.

The measurable checkpoint for supply and QA teams is successful commercial release of the 55 mg PFS against the validated specifications submitted in the EC dossier.

Source: AbbVie News Center via PR Newswire, 23 June 2026.