AbbVie Inc. — Skyrizi EMA EPAR variation assessment report (EMEA/H/C/004759, 2019)
AbbVie Inc. · 2019 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of Skyrizi (risankizumab) for pediatric plaque psoriasis (PsO) in patients aged 6 to under 18. Study M19-977 evaluated pharmacokinetics, safety, and efficacy, demonstrating sustained clinical improvement in PsO extent and severity over 52 weeks. The safety profile aligned with adult observations. An indication extension for pediatric PsO is anticipated in 2025.
Key findings — cited to the page
| Number of adolescents in Part 1 | 12 | M19-977 · p.5 |
| Ustekinumab SC dose for subjects 60 to < 100 kg (Part 2 Period A) | 45 mg | M19-977 · p.5 |
| Procedure number | EMA/PAM/0000265652 | Skyrizi (Risankizumab) · p.1 |
| Age range of patients in study M19-977 | 6 to less than 18 years | M19-977 · p.4 |
| Number of adolescents in Part 2 | 82 | M19-977 · p.5 |
| Ustekinumab SC dose for subjects < 60 kg (Part 2 Period A) | 0.75 mg/kg | M19-977 · p.5 |
| Submission date of completed paediatric study | 8 April 2025 | Skyrizi (risankizumab) · p.4 |
| Planned indication extension submission year | 2025 | risankizumab in paediatric PsO · p.4 |
| Risankizumab SC dose (Part 1) | 150 mg | M19-977 · p.4 |
| Risankizumab SC dose for subjects >= 40 kg (Parts 2, 3, 4) | 150 mg | M19-977 · p.4 |
| Risankizumab SC dose for subjects < 40 kg (Parts 2, 3, 4) | 55 mg | M19-977 · p.4 |
| Ustekinumab SC dose for subjects >= 100 kg (Part 2 Period A) | 90 mg | M19-977 · p.5 |
Source: AbbVie Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →