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
AbbVie Inc. submitted a variation for Skyrizi (risankizumab) to include a new 55 mg strength and a pediatric indication for moderate to severe plaque psoriasis in children aged 6 and older. Based on studies M19-977 and M19-973, the CHMP issued a positive opinion. The new 55 mg pre-filled syringe demonstrated comparable quality to existing formulations. Non-clinical data supported pediatric use without new animal studies. Clinical studies established pharmacokinetics, safety, and efficacy, supporting a weight-based dosing regimen (55 mg or 150 mg SC) achieving adult-equivalent exposures. Efficacy, measured by PASI 75/90/100 and sPGA 0/1, was maintained long-term. The safety profile was consistent with adult data, with no new concerns, and a positive benefit-risk balance was concluded.
Key findings — cited to the page
| Estimated median steady-state peak plasma concentration for risankizumab in pediatric subjects weighing < 40 kg | 11.1 µg/mL | · p.48 |
| Age range for Part 1 of Study M19-977 | 12 to <18 years | Study M19-977 Part 1 · p.49 |
| Risankizumab dose for pediatric patients weighing ≥ 40 kg | 150 mg SC | · p.48 |
| Estimated median steady-state trough plasma concentration for risankizumab in pediatric subjects weighing ≥ 40 kg | 2.3 µg/mL | · p.48 |
| Study M19-977 design | randomised, active-controlled, efficacy assessor-blinded | Study M19-977 · p.49 |
| Number of adolescents in Part 1 of Study M19-977 | 12 adolescents | Study M19-977 Part 1 · p.49 |
| Total subjects enrolled | 139 | Study M19-977 · Canada, Germany, Japan, Poland, Spain, United Kingdom, United States · p.61 |
| Age range of patients in Study M19-977 | 6 to <18 years | Study M19-977 · p.46 |
| Risankizumab dose for pediatric patients weighing < 40 kg | 55 mg SC | · p.48 |
| Estimated median steady-state peak plasma concentration for risankizumab in pediatric subjects weighing ≥ 40 kg | 15.7 µg/mL | · p.48 |
| Estimated median steady-state trough plasma concentration for risankizumab in pediatric subjects weighing < 40 kg | 1.6 µg/mL | · p.48 |
| Number of adolescents in Part 2 of Study M19-977 | 82 adolescents | Study M19-977 Part 2 · p.49 |
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 →